{
"title": "Site Recruitment Questionnaire",
"pages": [{
"name": "General",
"elements": [{
"type": "radiogroup",
"name": "If your site is selected: Do you agree to be listed as a study site on clinical trials.gov?_118",
"title": "If your site is selected: Do you agree to be listed as a study site on clinical trials.gov?",
"valueName": "If your site is selected: Do you agree to be listed as a study site on clinical trials gov?_118",
"qstRecId": "118",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}],
"title": "General"
}, {
"name": "Site Experience",
"elements": [{
"type": "text",
"name": "How many clinical studies in patients with advanced/metastatic solid tumors have you conducted in the last 5 years?_1597175793012",
"title": "How many clinical studies in patients with advanced/metastatic solid tumors have you conducted in the last 5 years?",
"isRequired": true,
"qstRecId": 1597175793012,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Please indicate the total number of phase I dose escalation studies that you have conducted in the last 5 years. _1597267399801",
"title": "Please indicate the total number of phase I dose escalation studies that you have conducted in the last 5 years. ",
"valueName": "Please indicate the total number of phase I dose escalation trials that you have conducted in the last 5 years _1597267399801",
"isRequired": true,
"qstRecId": 1597267399801,
"questionType": "Yes/No",
"choices": ["0", "1 - 5 studies", "6+ studies"]
}, {
"type": "radiogroup",
"name": "Please indicate the total number of studies in patients with sarcoma (including, but not limited to Ewing’s sarcoma and alveolar rhabdomyosarcoma) you have participated in within the last 5 years?_1613126530598",
"title": "Please indicate the total number of studies in patients with sarcoma (including, but not limited to Ewing’s sarcoma and alveolar rhabdomyosarcoma) you have participated in within the last 5 years?",
"isRequired": true,
"qstRecId": 1613126530598,
"questionType": "Yes/No",
"choices": ["0 studies", "1-3 studies", "4-5 studies", "6+ studies"]
}, {
"type": "text",
"name": "Please share the details of the 5 most recent phase I/Ib clinical studies in oncology that you have conducted in the last 5 years. (ex: Year enrollment achieved, Study Phase, Indication, # of patients enrolled. Please do not include protocol number/sponsor name)_1613515382897",
"title": "Please share the details of the 5 most recent phase I/Ib clinical studies in oncology that you have conducted in the last 5 years. (ex: Year enrollment achieved, Study Phase, Indication, # of patients enrolled. Please do not include protocol number/sponsor name)",
"valueName": "Please share the details of the 5 most recent phase I/Ib clinical studies in oncology that you have conducted in the last 5 years (ex: Year enrollment achieved, Study Phase, Indication, # of patients enrolled Please do not include protocol number/sponsor name)_1613515382897",
"isRequired": true,
"qstRecId": 1613515382897,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Have you ever participated in a First in Human (FIH) study?_158",
"title": "Have you ever participated in a First in Human (FIH) study?",
"valueName": "This is a First in Human (FIH) trial Have you ever participated in a FIH trial?_158",
"isRequired": true,
"qstRecId": "158",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please specify how many FIH studies you have participated in in the last 5 years._147",
"visibleIf": "{This is a First in Human (FIH) trial Have you ever participated in a FIH trial?_158} = \"Yes\"",
"startWithNewLine": false,
"title": "Please specify how many FIH studies you have participated in in the last 5 years.",
"valueName": "Please specify how many FIH studies you have participated in in the last 5 years _147",
"enableIf": "{This is a First in Human (FIH) trial Have you ever participated in a FIH trial?_158} = \"Yes\"",
"isRequired": true,
"validators": [{
"type": "numeric",
"minValue": 0
}],
"qstRecId": "147",
"isFromLib": true,
"questionType": "Number",
"inputType": "number"
}, {
"type": "radiogroup",
"name": "How many clinical studies with a PK/Biomarker component have you participated in within the last 5 years?_1597176777400",
"title": "How many clinical studies with a PK/Biomarker component have you participated in within the last 5 years?",
"isRequired": true,
"qstRecId": 1597176777400,
"questionType": "Yes/No",
"choices": ["0 studies", "1-3 studies", "4-5 studies", "6+ studies"]
}],
"title": "Site Experience"
}, {
"name": "Protocol Feasibility",
"elements": [{
"type": "panel",
"name": "Patient Population",
"elements": [{
"type": "radiogroup",
"name": "Would this study compete with other clinical studies at your center based on the subject selection criteria?_1597268808999",
"title": "Would this study compete with other clinical studies at your center based on the subject selection criteria?",
"isRequired": true,
"qstRecId": 1597268808999,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "How many competing studies do you currently have ongoing at your center?_1597669926168",
"visibleIf": "{Would this study compete with other clinical studies at your center based on the subject selection criteria?_1597268808999} = \"Yes\"",
"startWithNewLine": false,
"title": "How many competing studies do you currently have ongoing at your center?",
"enableIf": "{Would this study compete with other clinical studies at your center based on the subject selection criteria?_1597268808999} = \"Yes\"",
"isRequired": true,
"qstRecId": 1597669926168,
"questionType": "Text"
}, {
"type": "text",
"name": "When does recruitment end for the competing study(ies)?_a8X0y000000PPBf",
"visibleIf": "{Would this study compete with other clinical studies at your center based on the subject selection criteria?_1597268808999} = \"Yes\"",
"startWithNewLine": false,
"title": "When does recruitment end for the competing study(ies)?",
"enableIf": "{Would this study compete with other clinical studies at your center based on the subject selection criteria?_1597268808999} = \"Yes\"",
"isRequired": true,
"qstRecId": "a8X0y000000PPBf",
"isFromLib": true,
"questionType": "Date",
"inputType": "date"
}],
"title": "Patient Population"
}, {
"type": "panel",
"name": "Approximately how many new patients with each of the tumor types below are seen per year at your institution by the principal investigator and any planned sub-investigators? (Include patients with locally advanced/metastatic disease only)Enter '0' if you do not treat the population.",
"elements": [{
"type": "text",
"name": "Relapsed or refracted Solid Tumors (all histologies) seen per year?_1597177361484",
"title": "Relapsed or refracted Solid Tumors (all histologies) seen per year?",
"isRequired": true,
"qstRecId": 1597177361484,
"questionType": "Text"
}, {
"type": "text",
"name": "Non-small cell lung cancer seen per year?_1597177518357",
"startWithNewLine": false,
"title": "Non-small cell lung cancer seen per year?",
"isRequired": true,
"qstRecId": 1597177518357,
"questionType": "Text"
}, {
"type": "text",
"name": "Triple negative breast cancer seen per year?_1597177623406",
"startWithNewLine": false,
"title": "Triple negative breast cancer seen per year?",
"isRequired": true,
"qstRecId": 1597177623406,
"questionType": "Text"
}, {
"type": "text",
"name": "Gastric/GE junction adenocarcinoma seen per year?_1597177630978",
"startWithNewLine": false,
"title": "Gastric/GE junction adenocarcinoma seen per year?",
"isRequired": true,
"qstRecId": 1597177630978,
"questionType": "Text"
}, {
"type": "text",
"name": "Chordoma seen per year?_1597177633656",
"title": "Chordoma seen per year?",
"isRequired": true,
"qstRecId": 1597177633656,
"questionType": "Text"
}, {
"type": "text",
"name": "Ewing's sarcoma seen per year?_1597177641430",
"startWithNewLine": false,
"title": "Ewing's sarcoma seen per year?",
"isRequired": true,
"qstRecId": 1597177641430,
"questionType": "Text"
}, {
"type": "text",
"name": "Alveolar rhabdomyosarcoma seen per year?_1597269864484",
"startWithNewLine": false,
"title": "Alveolar rhabdomyosarcoma seen per year?",
"isRequired": true,
"qstRecId": 1597269864484,
"questionType": "Text"
}, {
"type": "text",
"name": "Midline NUT carcinoma seen per year?_1597177637484",
"startWithNewLine": false,
"title": "Midline NUT carcinoma seen per year?",
"isRequired": true,
"qstRecId": 1597177637484,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "What is the basis for your estimates above?_1597177938773",
"title": "What is the basis for your estimates above?",
"isRequired": true,
"qstRecId": 1597177938773,
"questionType": "Yes/No",
"choices": ["Patient database or billing information", "Estimates by recall", "Other"]
}, {
"type": "text",
"name": "Please specify basis for treatment estimates._1597863810072",
"visibleIf": "{What is the basis for your estimates above?_1597177938773} = \"Other\"",
"startWithNewLine": false,
"title": "Please specify basis for treatment estimates.",
"valueName": "Please specify basis for treatment estimates _1597863810072",
"enableIf": "{What is the basis for your estimates above?_1597177938773} = \"Other\"",
"isRequired": true,
"qstRecId": 1597863810072,
"questionType": "Text"
}],
"title": "Approximately how many new patients with each of the tumor types below are seen per year at your institution by the principal investigator and any planned sub-investigators? (Include patients with locally advanced/metastatic disease only)Enter '0' if you do not treat the population."
}, {
"type": "panel",
"name": "Subject Recruitment: Part 2: Dose Expansion",
"elements": [{
"type": "text",
"name": "Based on your experience and considering the inclusion and exclusion criteria, and the planned enrollment period (approximately 12 months), please estimate your enrollment potential (dosed) for Part 2 Cohort A: Dose Expansion._1597178450319",
"title": "Based on your experience and considering the inclusion and exclusion criteria, and the planned enrollment period (approximately 12 months), please estimate your enrollment potential (dosed) for Part 2 Cohort A: Dose Expansion.",
"valueName": "Based on your experience and considering the inclusion and exclusion criteria, and the planned enrollment period (approximately 12 months), please estimate your enrollment potential (dosed) for Part 2 Cohort A: Dose Expansion _1597178450319",
"isRequired": true,
"qstRecId": 1597178450319,
"questionType": "Text"
}, {
"type": "text",
"name": "Based on your experience and considering the inclusion and exclusion criteria, and the planned enrollment period (approximately 12 months), please estimate your enrollment potential (dosed) for Part 2 Cohort B: Dose Expansion._1613127030807",
"title": "Based on your experience and considering the inclusion and exclusion criteria, and the planned enrollment period (approximately 12 months), please estimate your enrollment potential (dosed) for Part 2 Cohort B: Dose Expansion.",
"valueName": "Based on your experience and considering the inclusion and exclusion criteria, and the planned enrollment period (approximately 12 months), please estimate your enrollment potential (dosed) for Part 2 Cohort B: Dose Expansion _1613127030807",
"isRequired": true,
"qstRecId": 1613127030807,
"questionType": "Text"
}, {
"type": "text",
"name": "Comments regarding Part 2: Dose Expansion enrollment estimates._1597863962892",
"title": "Comments regarding Part 2: Dose Expansion enrollment estimates.",
"valueName": "Comments regarding Part 2: Dose Expansion enrollment estimates _1597863962892",
"qstRecId": 1597863962892,
"questionType": "Text"
}, {
"type": "checkbox",
"name": "How do you plan to recruit subjects?_1613499940960",
"title": "How do you plan to recruit subjects?",
"isRequired": true,
"qstRecId": 1613499940960,
"questionType": "Multi-picklist",
"choices": ["Database", "Patient Referrals", "Advertising", "Other, please specify"],
"choicesOrder": "asc"
}, {
"type": "text",
"name": "Please specify recruitment plans._1613500038997",
"visibleIf": "{How do you plan to recruit subjects?_1613499940960} contains \"Other, please specify\"",
"startWithNewLine": false,
"title": "Please specify recruitment plans.",
"valueName": "Please specify recruitment plans _1613500038997",
"isRequired": true,
"qstRecId": 1613500038997,
"questionType": "Text"
}],
"title": "Subject Recruitment: Part 2: Dose Expansion"
}, {
"type": "panel",
"name": "Please estimate the number of patients your site would be likely to enroll with each of the listed histologies in a 12 month period. Please estimate conservatively. If you are not confident in your ability to enroll in a given disease type, please enter '0'.",
"elements": [{
"type": "text",
"name": "Relapsed/Refractory Non-small cell lung cancer patients able to enroll in 12 months?_1597178664606",
"title": "Relapsed/Refractory Non-small cell lung cancer patients able to enroll in 12 months?",
"isRequired": true,
"qstRecId": 1597178664606,
"questionType": "Text"
}, {
"type": "text",
"name": "Relapsed/Refractory Triple negative breast cancer patients able to enroll in 12 months?_1597178662671",
"startWithNewLine": false,
"title": "Relapsed/Refractory Triple negative breast cancer patients able to enroll in 12 months?",
"isRequired": true,
"qstRecId": 1597178662671,
"questionType": "Text"
}, {
"type": "text",
"name": "Relapsed/Refractory Gastric/GE junction adenocarcinoma patients able to enroll in 12 months?_1597178658987",
"startWithNewLine": false,
"title": "Relapsed/Refractory Gastric/GE junction adenocarcinoma patients able to enroll in 12 months?",
"isRequired": true,
"qstRecId": 1597178658987,
"questionType": "Text"
}, {
"type": "text",
"name": "Relapsed/Refractory Chordoma patients able to enroll in 12 months?_1597178660812",
"startWithNewLine": false,
"title": "Relapsed/Refractory Chordoma patients able to enroll in 12 months?",
"isRequired": true,
"qstRecId": 1597178660812,
"questionType": "Text"
}, {
"type": "text",
"name": "Relapsed/Refractory Ewing's sarcoma patients able to enroll in 12 months?_1597178638515",
"title": "Relapsed/Refractory Ewing's sarcoma patients able to enroll in 12 months?",
"isRequired": true,
"qstRecId": 1597178638515,
"questionType": "Text"
}, {
"type": "text",
"name": "Relapsed/Refractory Alveolar rhabdomyosarcoma patients able to enroll in 12 months?_1597178656884",
"startWithNewLine": false,
"title": "Relapsed/Refractory Alveolar rhabdomyosarcoma patients able to enroll in 12 months?",
"isRequired": true,
"qstRecId": 1597178656884,
"questionType": "Text"
}, {
"type": "text",
"name": "Relapsed/Refractory Midline NUT carcinoma patients able to enroll in 12 months?_1597178651191",
"startWithNewLine": false,
"title": "Relapsed/Refractory Midline NUT carcinoma patients able to enroll in 12 months?",
"isRequired": true,
"qstRecId": 1597178651191,
"questionType": "Text"
}],
"title": "Please estimate the number of patients your site would be likely to enroll with each of the listed histologies in a 12 month period. Please estimate conservatively. If you are not confident in your ability to enroll in a given disease type, please enter '0'."
}, {
"type": "panel",
"name": "Protocol Feedback",
"elements": [{
"type": "radiogroup",
"name": "Do you anticipate any challenges with the current study design?_1597179011440",
"title": "Do you anticipate any challenges with the current study design?",
"isRequired": true,
"qstRecId": 1597179011440,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please comment on study design challenges._1597864132425",
"visibleIf": "{Do you anticipate any challenges with the current study design?_1597179011440} = \"Yes\"",
"startWithNewLine": false,
"title": "Please comment on study design challenges.",
"valueName": "Please comment on study design challenges _1597864132425",
"enableIf": "{Do you anticipate any challenges with the current study design?_1597179011440} = \"Yes\"",
"qstRecId": 1597864132425,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "In your opinion, is there any particular inclusion criterion that may present a significant recruitment obstacle for this study?_1597179518496",
"title": "In your opinion, is there any particular inclusion criterion that may present a significant recruitment obstacle for this study?",
"isRequired": true,
"qstRecId": 1597179518496,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please provide inclusion criterion number and comments._1597864267073",
"visibleIf": "{In your opinion, is there any particular inclusion criterion that may present a significant recruitment obstacle for this study?_1597179518496} = \"Yes\"",
"startWithNewLine": false,
"title": "Please provide inclusion criterion number and comments.",
"valueName": "Please provide inclusion criterion number and comments _1597864267073",
"enableIf": "{In your opinion, is there any particular inclusion criterion that may present a significant recruitment obstacle for this study?_1597179518496} = \"Yes\"",
"qstRecId": 1597864267073,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "In your opinion, is there any particular exclusion criterion that may present a significant recruitment obstacle for this study?_1597179639858",
"title": "In your opinion, is there any particular exclusion criterion that may present a significant recruitment obstacle for this study?",
"isRequired": true,
"qstRecId": 1597179639858,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please provide exclusion criterion number and comments._1597864313072",
"visibleIf": "{In your opinion, is there any particular exclusion criterion that may present a significant recruitment obstacle for this study?_1597179639858} = \"Yes\"",
"startWithNewLine": false,
"title": "Please provide exclusion criterion number and comments.",
"valueName": "Please provide exclusion criterion number and comments _1597864313072",
"enableIf": "{In your opinion, is there any particular exclusion criterion that may present a significant recruitment obstacle for this study?_1597179639858} = \"Yes\"",
"qstRecId": 1597864313072,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Based on your review of the protocol synopsis, do you foresee any additional issues or challenges that might affect accrual in this study (new treatments, change in staff, etc.)?_1597179751050",
"title": "Based on your review of the protocol synopsis, do you foresee any additional issues or challenges that might affect accrual in this study (new treatments, change in staff, etc.)?",
"valueName": "Based on your review of the protocol synopsis, do you foresee any additional issues or challenges that might affect accrual in this study (new treatments, change in staff, etc )?_1597179751050",
"isRequired": true,
"qstRecId": 1597179751050,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please comment on additional issues or challenges._1597864354598",
"visibleIf": "{Based on your review of the protocol synopsis, do you foresee any additional issues or challenges that might affect accrual in this study (new treatments, change in staff, etc )?_1597179751050} = \"Yes\"",
"startWithNewLine": false,
"title": "Please comment on additional issues or challenges.",
"valueName": "Please comment on additional issues or challenges _1597864354598",
"enableIf": "{Based on your review of the protocol synopsis, do you foresee any additional issues or challenges that might affect accrual in this study (new treatments, change in staff, etc )?_1597179751050} = \"Yes\"",
"isRequired": true,
"qstRecId": 1597864354598,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Do you foresee any issues with the visit timepoints/frequency of visits in enrollment?_1613128484281",
"title": "Do you foresee any issues with the visit timepoints/frequency of visits in enrollment?",
"isRequired": true,
"qstRecId": 1613128484281,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please comment on potential issues with visit frequency._1613128523849",
"visibleIf": "{Do you foresee any issues with the visit timepoints/frequency of visits in enrollment?_1613128484281} = \"Yes\"",
"startWithNewLine": false,
"title": "Please comment on potential issues with visit frequency.",
"valueName": "Please comment on potential issues with visit frequency _1613128523849",
"isRequired": true,
"qstRecId": 1613128523849,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Due to sample stability, C1D1 can only occur on Mondays or Tuesdays. Do you foresee any recruitment challenges?_1613128568880",
"title": "Due to sample stability, C1D1 can only occur on Mondays or Tuesdays. Do you foresee any recruitment challenges?",
"valueName": "Due to sample stability, C1D1 can only occur on Mondays or Tuesdays Do you foresee any recruitment challenges?_1613128568880",
"isRequired": true,
"qstRecId": 1613128568880,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please comment on recruitment challenge due to requirement for C1D1 to occur on Mondays or Tuesdays._1613128595588",
"visibleIf": "{Due to sample stability, C1D1 can only occur on Mondays or Tuesdays Do you foresee any recruitment challenges?_1613128568880} = \"Yes\"",
"startWithNewLine": false,
"title": "Please comment on recruitment challenge due to requirement for C1D1 to occur on Mondays or Tuesdays.",
"valueName": "Please comment on recruitment challenge due to requirement for C1D1 to occur on Mondays or Tuesdays _1613128595588",
"isRequired": true,
"qstRecId": 1613128595588,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Is the imaging for the study as noted in the protocol considered standard of care at your institution?_1613128654508",
"title": "Is the imaging for the study as noted in the protocol considered standard of care at your institution?",
"isRequired": true,
"qstRecId": 1613128654508,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please comment on imaging at your institution._1613128681122",
"visibleIf": "{Is the imaging for the study as noted in the protocol considered standard of care at your institution?_1613128654508} = \"No\"",
"startWithNewLine": false,
"title": "Please comment on imaging at your institution.",
"valueName": "Please comment on imaging at your institution _1613128681122",
"isRequired": true,
"qstRecId": 1613128681122,
"questionType": "Text"
}],
"title": "Protocol Feedback"
}],
"title": "Protocol Feasibility"
}, {
"name": "Study Site Feasibility",
"elements": [{
"type": "panel",
"name": "COVID-19 Implications",
"elements": [{
"type": "radiogroup",
"name": "With the ongoing global COVID-19 pandemic, can your site engage in new clinical studies?_1597179910412",
"title": "With the ongoing global COVID-19 pandemic, can your site engage in new clinical studies?",
"isRequired": true,
"qstRecId": 1597179910412,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "Please try to estimate how soon your site may have the bandwidth and availability to accept new clinical studies._1597179959012",
"visibleIf": "{With the ongoing global COVID-19 pandemic, can your site engage in new clinical studies?_1597179910412} = \"No\"",
"startWithNewLine": false,
"title": "Please try to estimate how soon your site may have the bandwidth and availability to accept new clinical studies.",
"valueName": "Please try to estimate how soon your site may have the bandwidth and availability to accept new clinical studies _1597179959012",
"isRequired": true,
"qstRecId": 1597179959012,
"questionType": "Yes/No",
"choices": ["1-2 months", "3-4 months", "5+ months"]
}, {
"type": "radiogroup",
"name": "With the ongoing global COVID-19 pandemic, is patient recruitment impacted?_1597180047179",
"title": "With the ongoing global COVID-19 pandemic, is patient recruitment impacted?",
"isRequired": true,
"qstRecId": 1597180047179,
"questionType": "Yes/No",
"choices": ["Yes, no recruitment activities are taking place", "No, recruitment is ongoing"]
}, {
"type": "radiogroup",
"name": "With the ongoing global COVID-19 pandemic, is patient access to the site impacted? _1597180089130",
"title": "With the ongoing global COVID-19 pandemic, is patient access to the site impacted? ",
"isRequired": true,
"qstRecId": 1597180089130,
"questionType": "Yes/No",
"choices": ["Yes, patients only come for essential visits (dosing, CT scans etc.)", "Yes, at the moment study patients are not allowed at site and all activities are done remotely", "No, patients are coming for all planned study visits"]
}, {
"type": "radiogroup",
"name": "Due to COVID-19, are any research related procedures not being performed (i.e. biopsies, imaging for research only, etc.)?_1597180155108",
"title": "Due to COVID-19, are any research related procedures not being performed (i.e. biopsies, imaging for research only, etc.)?",
"valueName": "Due to COVID-19, are any research related procedures not being performed (i e biopsies, imaging for research only, etc )?_1597180155108",
"isRequired": true,
"qstRecId": 1597180155108,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please specify procedures not being performed._1597864421131",
"visibleIf": "{Due to COVID-19, are any research related procedures not being performed (i e biopsies, imaging for research only, etc )?_1597180155108} = \"Yes\"",
"startWithNewLine": false,
"title": "Please specify procedures not being performed.",
"valueName": "Please specify procedures not being performed _1597864421131",
"enableIf": "{Due to COVID-19, are any research related procedures not being performed (i e biopsies, imaging for research only, etc )?_1597180155108} = \"Yes\"",
"isRequired": true,
"qstRecId": 1597864421131,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Considering the ongoing global COVID-19 pandemic, is CRA access impacted?_1597180256800",
"title": "Considering the ongoing global COVID-19 pandemic, is CRA access impacted?",
"isRequired": true,
"qstRecId": 1597180256800,
"questionType": "Yes/No",
"choices": ["Yes, CRAs are not allowed on site", "No, on-site visits are taking place"]
}, {
"type": "radiogroup",
"name": "Is remote monitoring and/or remote source data verification (SDV) allowed?_1597180250699",
"title": "Is remote monitoring and/or remote source data verification (SDV) allowed?",
"isRequired": true,
"qstRecId": 1597180250699,
"questionType": "Yes/No",
"choices": ["Yes, remote SDV is possible", "Yes, remote monitoring is allowed but not remote SDV", "No"]
}, {
"type": "checkbox",
"name": "Are you currently granting CRA remote access for study monitoring via the following: (Select all that apply)_1613128794828",
"title": "Are you currently granting CRA remote access for study monitoring via the following: (Select all that apply)",
"isRequired": true,
"qstRecId": 1613128794828,
"questionType": "Multi-picklist",
"choices": ["Direct EMR Access", "Site Portal", "Virtual Meeting (WebEx)", "None"]
}, {
"type": "radiogroup",
"name": "Does the site portal meet all standards for use per national, regional and institutional requirements, laws, regulations, guidance, etc. for remote access to source documents that may contain personally identifiable and clinical data and has the site or institution performed an assessment against industry accepted standards?_1613128860997",
"visibleIf": "{Are you currently granting CRA remote access for study monitoring via the following: (Select all that apply)_1613128794828} contains \"Site Portal\"",
"startWithNewLine": false,
"title": "Does the site portal meet all standards for use per national, regional and institutional requirements, laws, regulations, guidance, etc. for remote access to source documents that may contain personally identifiable and clinical data and has the site or institution performed an assessment against industry accepted standards?",
"valueName": "Does the site portal meet all standards for use per national, regional and institutional requirements, laws, regulations, guidance, etc for remote access to source documents that may contain personally identifiable and clinical data and has the site or institution performed an assessment against industry accepted standards?_1613128860997",
"isRequired": true,
"qstRecId": 1613128860997,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "Did you previously restrict remote study monitoring access to the CRAs?_1613128897105",
"title": "Did you previously restrict remote study monitoring access to the CRAs?",
"isRequired": true,
"qstRecId": 1613128897105,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "checkbox",
"name": "What records will be available to the CRA remotely?_1613128938151",
"title": "What records will be available to the CRA remotely?",
"isRequired": true,
"qstRecId": 1613128938151,
"questionType": "Multi-picklist",
"choices": ["EMRs (Electronic Medical Records)", "Investigator Site File", "Pharmacy Documents (accountability logs, temperature logs, etc.)", "Informed Consent Forms (ICFs)", "Patient Diaries "]
}, {
"type": "radiogroup",
"name": "With the ongoing global COVID-19 pandemic, has your staffing been impacted? _1597180365071",
"title": "With the ongoing global COVID-19 pandemic, has your staffing been impacted? ",
"isRequired": true,
"qstRecId": 1597180365071,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "What staff are on limited availability? Please specify._1597864502977",
"visibleIf": "{With the ongoing global COVID-19 pandemic, has your staffing been impacted? _1597180365071} = \"Yes\"",
"startWithNewLine": false,
"title": "What staff are on limited availability? Please specify.",
"valueName": "What staff are on limited availability? Please specify _1597864502977",
"enableIf": "{With the ongoing global COVID-19 pandemic, has your staffing been impacted? _1597180365071} = \"Yes\"",
"qstRecId": 1597864502977,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Does the site have contingency plans such as home health for protocol required blood draws, or telehealth for visits if the subject is unable to return to the clinic?_1597180617021",
"title": "Does the site have contingency plans such as home health for protocol required blood draws, or telehealth for visits if the subject is unable to return to the clinic?",
"isRequired": true,
"qstRecId": 1597180617021,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}],
"title": "COVID-19 Implications"
}],
"title": "Study Site Feasibility"
}, {
"name": "Research Staff",
"elements": [{
"type": "checkbox",
"name": "What type of dedicated staff do you have to assist in research? (Check all that apply) Please ensure all staff have been added to the Site Staff tab._121",
"title": "What type of dedicated staff do you have to assist in research? (Check all that apply) Please ensure all staff have been added to the Site Staff tab.",
"valueName": "What type of dedicated staff do you have to assist in research? (Check all that apply) Please ensure all staff have been added to the Site Staff tab _121",
"isRequired": true,
"qstRecId": "121",
"isFromLib": true,
"questionType": "Multi-picklist",
"choices": ["None", "Study Coordinator", "Data Manager", "Sub-Investigator", "Pharmacist", "Study Nurse", "Nurse (Other)", "Lab Personnel", "Other"]
}, {
"type": "text",
"name": "Please specify other staff._99",
"visibleIf": "{What type of dedicated staff do you have to assist in research? (Check all that apply) Please ensure all staff have been added to the Site Staff tab _121} contains \"Other\"",
"startWithNewLine": false,
"title": "Please specify other staff.",
"valueName": "Please specify other staff _99",
"isRequired": true,
"qstRecId": "99",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Is a pediatrician part of your study team? _150",
"title": "Is a pediatrician part of your study team? ",
"isRequired": true,
"qstRecId": "150",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}],
"title": "Research Staff"
}, {
"name": "Site Capabilities",
"elements": [{
"type": "radiogroup",
"name": "Does your site have suitable facilities, procedures and personnel to run FIH and Phase 1 studies, including risk assessment procedures, appropriate emergency procedures and equipment?_1597181346555",
"title": "Does your site have suitable facilities, procedures and personnel to run FIH and Phase 1 studies, including risk assessment procedures, appropriate emergency procedures and equipment?",
"valueName": "Does your site have suitable facilities, procedures and personnel to run FIH and phase1 studies, including risk assessment procedures, appropriate emergency procedures and equipment (e g resuscitating equipment, diagnostic equipment and supportive care/medications such as oxygen, antihistamines, acetaminophen, corticosteroids, epinephrine, and bronchodilators readily available)?_1597181346555",
"isRequired": true,
"qstRecId": 1597181346555,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please comment on FIH capabilities at your site._1597864592871",
"visibleIf": "{Does your site have suitable facilities, procedures and personnel to run FIH and phase1 studies, including risk assessment procedures, appropriate emergency procedures and equipment (e g resuscitating equipment, diagnostic equipment and supportive care/medications such as oxygen, antihistamines, acetaminophen, corticosteroids, epinephrine, and bronchodilators readily available)?_1597181346555} = \"No\"",
"startWithNewLine": false,
"title": "Please comment on FIH capabilities at your site.",
"valueName": "Please comment on FIH capabilities at your site _1597864592871",
"enableIf": "{Does your site have suitable facilities, procedures and personnel to run FIH and phase1 studies, including risk assessment procedures, appropriate emergency procedures and equipment (e g resuscitating equipment, diagnostic equipment and supportive care/medications such as oxygen, antihistamines, acetaminophen, corticosteroids, epinephrine, and bronchodilators readily available)?_1597181346555} = \"No\"",
"isRequired": true,
"qstRecId": 1597864592871,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Are you aware of any requirements for a phase I accreditation in your country? _131",
"title": "Are you aware of any requirements for a phase I accreditation in your country? ",
"isRequired": true,
"qstRecId": "131",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "Do you or your site have the required phase I accreditation?_46",
"title": "Do you or your site have the required phase I accreditation?",
"isRequired": true,
"qstRecId": "46",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "checkbox",
"name": "First in Human trial have special requirements for the conduct of FIH trials with the aim of minimizing the risks to subject safety. Which of the following does your site have in accordance with FIH trial requirements and local / national guidelines for FIH trials? (Select all that apply)_77",
"title": "First in Human trial have special requirements for the conduct of FIH trials with the aim of minimizing the risks to subject safety. Which of the following does your site have in accordance with FIH trial requirements and local / national guidelines for FIH trials? (Select all that apply)",
"valueName": "First in Human trial have special requirements for the conduct of FIH trials with the aim of minimizing the risks to subject safety Which of the following does your site have in accordance with FIH trial requirements and local / national guidelines for FIH trials? (Select all that apply)_77",
"isRequired": true,
"qstRecId": "77",
"isFromLib": true,
"questionType": "Multi-picklist",
"choices": ["Suitable facilities for study drug administration, subject observation", "Staff trained in FIH trial requirements (dose administration, emergency protocol and procedures)", "Emergency strategies ", "Emergency equipment"]
}, {
"type": "dropdown",
"name": "Does your country have any special tissue license or other requirements that would need to be met so this trial can be conducted in your country?_259",
"title": "Does your country have any special tissue license or other requirements that would need to be met so this trial can be conducted in your country?",
"isRequired": true,
"qstRecId": "259",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "Would your site be able to provide blood samples for biomarker testing?_1597181476002",
"title": "Would your site be able to provide blood samples for biomarker testing?",
"isRequired": true,
"qstRecId": 1597181476002,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please comment on why your site would not be able to provide blood samples._1597864635762",
"visibleIf": "{Would your site be able to provide blood samples for biomarker testing?_1597181476002} = \"No\"",
"startWithNewLine": false,
"title": "Please comment on why your site would not be able to provide blood samples.",
"valueName": "Please comment on why your site would not be able to provide blood samples _1597864635762",
"enableIf": "{Would your site be able to provide blood samples for biomarker testing?_1597181476002} = \"No\"",
"isRequired": true,
"qstRecId": 1597864635762,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Does your site routinely or commonly perform next generation sequencing for patients with the tumor types included in this trial?_1613129333580",
"title": "Does your site routinely or commonly perform next generation sequencing for patients with the tumor types included in this trial?",
"isRequired": true,
"qstRecId": 1613129333580,
"questionType": "Yes/No",
"choices": ["Yes", "Yes, for some tumor types", "No"]
}, {
"type": "text",
"name": "Please specify which tumor types._1613129371431",
"visibleIf": "{Does your site routinely or commonly perform next generation sequencing for patients with the tumor types included in this trial?_1613129333580} = \"Yes, for some tumor types\"",
"startWithNewLine": false,
"title": "Please specify which tumor types.",
"valueName": "Please specify which tumor types _1613129371431",
"isRequired": true,
"qstRecId": 1613129371431,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Is the next generation sequencing performed at your own institution or is it sent to an outside reference lab?_1613129423151",
"title": "Is the next generation sequencing performed at your own institution or is it sent to an outside reference lab?",
"isRequired": true,
"qstRecId": 1613129423151,
"questionType": "Yes/No",
"choices": ["Own institution", "Outside reference lab"]
}, {
"type": "text",
"name": "Please provide the name of the reference lab(s) you most commonly use._1613129463021",
"visibleIf": "{Is the next generation sequencing performed at your own institution or is it sent to an outside reference lab?_1613129423151} = \"Outside reference lab\"",
"startWithNewLine": false,
"title": "Please provide the name of the reference lab(s) you most commonly use.",
"valueName": "Please provide the name of the reference lab(s) you most commonly use _1613129463021",
"isRequired": true,
"qstRecId": 1613129463021,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Do the next generation sequencing panels you receive generally provide an estimate of MYC copy number?_1613129518924",
"title": "Do the next generation sequencing panels you receive generally provide an estimate of MYC copy number?",
"isRequired": true,
"qstRecId": 1613129518924,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please comment on estimate of MYC copy number._1613129546228",
"visibleIf": "{Do the next generation sequencing panels you receive generally provide an estimate of MYC copy number?_1613129518924} = \"No\"",
"startWithNewLine": false,
"title": "Please comment on estimate of MYC copy number.",
"valueName": "Please comment on estimate of MYC copy number _1613129546228",
"isRequired": true,
"qstRecId": 1613129546228,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Does your Site or ethics committee have any limitations on blood volume (per day, month, week, etc)?_1613129644206",
"title": "Does your Site or ethics committee have any limitations on blood volume (per day, month, week, etc)?",
"isRequired": true,
"qstRecId": 1613129644206,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please comment on blood volume restrictions._1613129708276",
"visibleIf": "{Does your Site or ethics committee have any limitations on blood volume (per day, month, week, etc)?_1613129644206} = \"Yes\"",
"startWithNewLine": false,
"title": "Please comment on blood volume restrictions.",
"valueName": "Please comment on blood volume restrictions _1613129708276",
"isRequired": true,
"qstRecId": 1613129708276,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Part 2 requires the first 10 subjects in each Cohort A and Cohort B with accessible tumor tissue to undergo paired biopsies at screening and between Days 22 and 24 of Cycle 1. Do you foresee any challenges? _1613129801913",
"title": "Part 2 requires the first 10 subjects in each Cohort A and Cohort B with accessible tumor tissue to undergo paired biopsies at screening and between Days 22 and 24 of Cycle 1. Do you foresee any challenges? ",
"valueName": "Part 2 requires the first 10 subjects in each Cohort A and Cohort B with accessible tumor tissue to undergo paired biopsies at screening and between Days 22 and 24 of Cycle 1 Do you foresee any challenges? _1613129801913",
"isRequired": true,
"qstRecId": 1613129801913,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please comment on challenges related to paired biopsies._1613129838796",
"visibleIf": "{Part 2 requires the first 10 subjects in each Cohort A and Cohort B with accessible tumor tissue to undergo paired biopsies at screening and between Days 22 and 24 of Cycle 1 Do you foresee any challenges? _1613129801913} = \"Yes\"",
"startWithNewLine": false,
"title": "Please comment on challenges related to paired biopsies.",
"valueName": "Please comment on challenges related to paired biopsies _1613129838796",
"isRequired": true,
"qstRecId": 1613129838796,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Is your site able to embed fresh tissue to create FFPE?_1613129910375",
"title": "Is your site able to embed fresh tissue to create FFPE?",
"isRequired": true,
"qstRecId": 1613129910375,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "If no, do you have a facility that can embed the tissue?_1613129941705",
"visibleIf": "{Is your site able to embed fresh tissue to create FFPE?_1613129910375} = \"No\"",
"startWithNewLine": false,
"title": "If no, do you have a facility that can embed the tissue?",
"isRequired": true,
"qstRecId": 1613129941705,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "Is your site able to send a minimum of 12 unstained slides?_1613129994142",
"title": "Is your site able to send a minimum of 12 unstained slides?",
"isRequired": true,
"qstRecId": 1613129994142,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "If no, what is the minimum number of unstained slides? _1613130027907",
"visibleIf": "{Is your site able to send a minimum of 12 unstained slides?_1613129994142} = \"No\"",
"startWithNewLine": false,
"title": "If no, what is the minimum number of unstained slides? ",
"isRequired": true,
"qstRecId": 1613130027907,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Can tissue biopsies be performed on site?_1597181659276",
"title": "Can tissue biopsies be performed on site?",
"isRequired": true,
"qstRecId": 1597181659276,
"questionType": "Yes/No",
"choices": ["Yes", "No, but we have a contracted affiliate", "No, we would need to identify and contract an affiliate"]
}, {
"type": "text",
"name": "Please specify the amount of lead time required for requesting a biopsy slot._1597181725682",
"title": "Please specify the amount of lead time required for requesting a biopsy slot.",
"valueName": "Please specify the amount of lead time required for requesting a biopsy slot _1597181725682",
"isRequired": true,
"qstRecId": 1597181725682,
"questionType": "Text"
}, {
"type": "text",
"name": "How are tumor measurements documented? Please describe._1597864687640",
"title": "How are tumor measurements documented? Please describe.",
"valueName": "How are tumor measurements documented? Please describe _1597864687640",
"isRequired": true,
"qstRecId": 1597864687640,
"questionType": "Text"
}, {
"type": "text",
"name": "Who is completing the final grading and outcome assessment (RECIST 1.1) and how/where/when is this documented? Please describe._1597864732866",
"title": "Who is completing the final grading and outcome assessment (RECIST 1.1) and how/where/when is this documented? Please describe.",
"valueName": "Who is completing the final grading and outcome assessment (RECIST 1 1) and how/where/when is this documented? Please describe _1597864732866",
"isRequired": true,
"qstRecId": 1597864732866,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Are CLIA and CAP certifications available for the laboratory used for this protocol?_218",
"title": "Are CLIA and CAP certifications available for the laboratory used for this protocol?",
"isRequired": true,
"qstRecId": "218",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "panel",
"name": "Do you have access to the following supplies/equipment with current documentation of maintenance/calibration required for this study?",
"elements": [{
"type": "radiogroup",
"name": "Dry Ice_17",
"title": "Dry Ice",
"isRequired": true,
"qstRecId": "17",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "IATA Certified Personnel_9",
"startWithNewLine": false,
"title": "IATA Certified Personnel",
"isRequired": true,
"qstRecId": "9",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "Centrifuge which can hold 5mL tubes and can go up to at least 2000x g for PK samples_211",
"startWithNewLine": false,
"title": "Centrifuge which can hold 5mL tubes and can go up to at least 2000x g for PK samples",
"isRequired": true,
"qstRecId": "211",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "-80 Celsius frost-free freezer_1613131068369",
"title": "-80 Celsius frost-free freezer",
"isRequired": true,
"qstRecId": 1613131068369,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "-70 Celsius frost-free freezer_8",
"startWithNewLine": false,
"title": "-70 Celsius frost-free freezer",
"isRequired": true,
"qstRecId": "8",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "-20 Celsius frost-free freezer_18",
"startWithNewLine": false,
"title": "-20 Celsius frost-free freezer",
"isRequired": true,
"qstRecId": "18",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "4 Celsius refrigerator_1613130931314",
"title": "4 Celsius refrigerator",
"isRequired": true,
"qstRecId": 1613130931314,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "checkbox",
"name": "What type of radiographic tests are you capable of providing? (i.e. MRI, X-Rays)?_76",
"startWithNewLine": false,
"title": "What type of radiographic tests are you capable of providing? (i.e. MRI, X-Rays)?",
"valueName": "What type of radiographic tests are you capable of providing? (i e MRI, X-Rays)?_76",
"isRequired": true,
"qstRecId": "76",
"isFromLib": true,
"questionType": "Multi-picklist",
"choices": ["CT", "MRI", "X-Ray"]
}, {
"type": "radiogroup",
"name": "If your site does not have access to CT/MRI scan, can you access in a separate facility?_1613131474857",
"startWithNewLine": false,
"title": "If your site does not have access to CT/MRI scan, can you access in a separate facility?",
"isRequired": true,
"qstRecId": 1613131474857,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "If yes, please note if you foresee any logistical issues with patient scheduling and/or performing assessments with this equipment._1613131587051",
"visibleIf": "{If your site does not have access to CT/MRI scan, can you access in a separate facility?_1613131474857} = \"Yes\"",
"title": "If yes, please note if you foresee any logistical issues with patient scheduling and/or performing assessments with this equipment.",
"valueName": "If yes, please note if you foresee any logistical issues with patient scheduling and/or performing assessments with this equipment _1613131587051",
"qstRecId": 1613131587051,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Does your facility have access to Multigated acquisition (MUGA) scan or ECHO?_1613131647463",
"title": "Does your facility have access to Multigated acquisition (MUGA) scan or ECHO?",
"isRequired": true,
"qstRecId": 1613131647463,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "Can your site use central ECG vendor and transmit ECG via internet?_1613131828374",
"title": "Can your site use central ECG vendor and transmit ECG via internet?",
"isRequired": true,
"qstRecId": 1613131828374,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please comment on why a central ECG vendor cannot be used by your site._1613131871697",
"visibleIf": "{Can your site use central ECG vendor and transmit ECG via internet?_1613131828374} = \"No\"",
"startWithNewLine": false,
"title": "Please comment on why a central ECG vendor cannot be used by your site.",
"valueName": "Please comment on why a central ECG vendor cannot be used by your site _1613131871697",
"isRequired": true,
"qstRecId": 1613131871697,
"questionType": "Text"
}],
"title": "Do you have access to the following supplies/equipment with current documentation of maintenance/calibration required for this study?"
}, {
"type": "radiogroup",
"name": "Does the site data coordination staff have the ability to enter all data, including AEs and concomitant medications within 5 days of a visits so that data can be available for data review?_1597182810297",
"title": "Does the site data coordination staff have the ability to enter all data, including AEs and concomitant medications within 5 days of a visits so that data can be available for data review?",
"qstRecId": 1597182810297,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please comment on why data cannot be entered within 5 days of a visit._1597865266108",
"visibleIf": "{Does the site data coordination staff have the ability to enter all data, including AEs and concomitant medications within 5 days of a visits so that data can be available for data review?_1597182810297} = \"No\"",
"startWithNewLine": false,
"title": "Please comment on why data cannot be entered within 5 days of a visit.",
"valueName": "Please comment on why data cannot be entered within 5 days of a visit _1597865266108",
"isRequired": true,
"qstRecId": 1597865266108,
"questionType": "Text"
}, {
"type": "text",
"name": "Who consents patients for clinical trials at your site? Please describe the patient consent procedure followed at your site._1597865304685",
"title": "Who consents patients for clinical trials at your site? Please describe the patient consent procedure followed at your site.",
"valueName": "Who consents patients for clinical trials at your site? Please describe the patient consent procedure followed at your site _1597865304685",
"isRequired": true,
"qstRecId": 1597865304685,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Will you be using any additional facilities (labs, radiology, imaging centers, etc.) to conduct this study?_1613132782751",
"title": "Will you be using any additional facilities (labs, radiology, imaging centers, etc.) to conduct this study?",
"valueName": "Will you be using any additional facilities (labs, radiology, imaging centers, etc ) to conduct this study?_1613132782751",
"isRequired": true,
"qstRecId": 1613132782751,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "If Yes, please specify number of additional facilities and ensure each facility has been added to the list of Addresses to be used for the study._1613133044144",
"visibleIf": "{Will you be using any additional facilities (labs, radiology, imaging centers, etc ) to conduct this study?_1613132782751} = \"Yes\"",
"startWithNewLine": false,
"title": "If Yes, please specify number of additional facilities and ensure each facility has been added to the list of Addresses to be used for the study.",
"valueName": "If Yes, please specify number of additional facilities and ensure each facility has been added to the list of Addresses to be used for the study _1613133044144",
"isRequired": true,
"qstRecId": 1613133044144,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Will a separate contract between the CRO and the facility be required?_1613133147304",
"visibleIf": "{Will you be using any additional facilities (labs, radiology, imaging centers, etc ) to conduct this study?_1613132782751} = \"Yes\"",
"startWithNewLine": false,
"title": "Will a separate contract between the CRO and the facility be required?",
"isRequired": true,
"qstRecId": 1613133147304,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "panel",
"name": "Pharmacy",
"elements": [{
"type": "radiogroup",
"name": "Do you have a (local) pharmacy (or other secure location) to store and dispense trial drug? If Yes, please ensure pharmacy has been added to the list of Addresses to be used for the study and ticked for Drug Address._141",
"title": "Do you have a (local) pharmacy (or other secure location) to store and dispense trial drug? If Yes, please ensure pharmacy has been added to the list of Addresses to be used for the study and ticked for Drug Address.",
"valueName": "Do you have a (local) pharmacy (or other secure location) to store and dispense trial drug? If Yes, please ensure pharmacy has been added to the list of Addresses to be used for the study and ticked for Drug Address _141",
"isRequired": true,
"qstRecId": "140",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Where does the pharmacy store the refrigerated (2-8C) IP?_1597272702656",
"visibleIf": "{Do you have a (local) pharmacy (or other secure location) to store and dispense trial drug? If Yes, please ensure pharmacy has been added to the list of Addresses to be used for the study and ticked for Drug Address _141} = \"Yes\"",
"title": "Where does the pharmacy store the refrigerated (2-8C) IP?",
"enableIf": "{Do you have a (local) pharmacy (or other secure location) to store and dispense trial drug? If Yes, please ensure pharmacy has been added to the list of Addresses to be used for the study and ticked for Drug Address _141} = \"Yes\"",
"isRequired": true,
"qstRecId": 1597272702656,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "A daily temperature log of the drug storage area must be maintained every working day. Do you have a calibrated refrigerated (2-8C) IP temperature monitoring device?_1613133561850",
"title": "A daily temperature log of the drug storage area must be maintained every working day. Do you have a calibrated refrigerated (2-8C) IP temperature monitoring device?",
"valueName": "A daily temperature log of the drug storage area must be maintained every working day Do you have a calibrated refrigerated (2-8C) IP temperature monitoring device?_1613133561850",
"isRequired": true,
"qstRecId": 1613133561850,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}],
"title": "Pharmacy"
}, {
"type": "panel",
"name": "Audit History",
"elements": [{
"type": "radiogroup",
"name": "Has your site/center(s) been inspected by health/regulatory authorities?_32",
"title": "Has your site/center(s) been inspected by health/regulatory authorities?",
"isRequired": true,
"qstRecId": "32",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "When did the inspection(s) occur? (MMM/YYYY)_35",
"visibleIf": "{Has your site/center(s) been inspected by health/regulatory authorities?_32} = \"Yes\"",
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"title": "When did the inspection(s) occur? (MMM/YYYY)",
"enableIf": "{Has your site/center(s) been inspected by health/regulatory authorities?_32} = \"Yes\"",
"isRequired": true,
"qstRecId": "35",
"isFromLib": true,
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}, {
"type": "text",
"name": "Who conducted the inspection(s) (e. g. regulatory authority, CRO, sponsor)?_34",
"visibleIf": "{Has your site/center(s) been inspected by health/regulatory authorities?_32} = \"Yes\"",
"title": "Who conducted the inspection(s) (e. g. regulatory authority, CRO, sponsor)?",
"valueName": "Who conducted the inspection(s) (e g regulatory authority, CRO, sponsor)?_34",
"enableIf": "{Has your site/center(s) been inspected by health/regulatory authorities?_32} = \"Yes\"",
"isRequired": true,
"qstRecId": "34",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "text",
"name": "What were the results of the inspection(s)? _142",
"visibleIf": "{Has your site/center(s) been inspected by health/regulatory authorities?_32} = \"Yes\"",
"title": "What were the results of the inspection(s)? ",
"enableIf": "{Has your site/center(s) been inspected by health/regulatory authorities?_32} = \"Yes\"",
"isRequired": true,
"qstRecId": "142",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Has your site ever been issued a FDA Form 483 warning letter?_98",
"visibleIf": "{Has your site/center(s) been inspected by health/regulatory authorities?_32} = \"Yes\"",
"title": "Has your site ever been issued a FDA Form 483 warning letter?",
"enableIf": "{Has your site/center(s) been inspected by health/regulatory authorities?_32} = \"Yes\"",
"isRequired": true,
"qstRecId": "98",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}],
"title": "Audit History"
}],
"title": "Site Capabilities"
}, {
"name": "Regional Start-up Requirements",
"elements": [{
"type": "radiogroup",
"name": "Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229",
"title": "Please select your region to be directed to the relevant questions regarding start-up requirements:",
"isRequired": true,
"qstRecId": 1597326206229,
"questionType": "Yes/No",
"choices": ["United States/US Territories subject to FDA regulations and Canada", "Europe/Asia-pacific/Africa/Latin America"]
}, {
"type": "panel",
"name": "Central and/or Local Institutional Review Boards / Independent Ethics Committees (United States/Canada) Please make sure an IRB/IEC contact is added to the Site Staff tab along with their contact information.",
"elements": [{
"type": "radiogroup",
"name": "Will your site use a Central or Local IRB for this study?_1597256953819",
"visibleIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"United States/US Territories subject to FDA regulations and Canada\"",
"title": "Will your site use a Central or Local IRB for this study?",
"enableIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"United States/US Territories subject to FDA regulations and Canada\"",
"isRequired": true,
"qstRecId": 1597256953819,
"questionType": "Yes/No",
"choices": ["Central", "Local"]
}, {
"type": "dropdown",
"name": "Is your site able to use Advarra as the Central IRB for this study?_294",
"visibleIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Central\"",
"title": "Is your site able to use Advarra as the Central IRB for this study?",
"valueName": "Sites are expected to utilize the contracted Central IRB <XXXX> for this study Is your site able to use <XXXX>?",
"enableIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Central\"",
"isRequired": true,
"qstRecId": "294",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please indicate the name of the Central IRB your site is able to use for the study._251",
"visibleIf": "{Sites are expected to utilize the contracted Central IRB <XXXX> for this study Is your site able to use <XXXX>?} = \"No\"",
"startWithNewLine": false,
"title": "Please indicate the name of the Central IRB your site is able to use for the study.",
"valueName": "Please indicate the name of the Central IRB your site is able to use for the study _251",
"enableIf": "{Sites are expected to utilize the contracted Central IRB <XXXX> for this study Is your site able to use <XXXX>?} = \"No\"",
"qstRecId": "251",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "How often does your Local IRB/IEC meet? ",
"visibleIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"title": "How often does your Local IRB/IEC meet? ",
"enableIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"isRequired": true,
"qstRecId": "204",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["Weekly", "Twice a month", "Monthly", "As needed", "Other"]
}, {
"type": "text",
"name": "If Other, please further specify IRB/IEC meeting frequency._184",
"visibleIf": "{How often does your Local IRB/IEC meet? } = \"Other\"",
"startWithNewLine": false,
"title": "If Other, please further specify IRB/IEC meeting frequency.",
"valueName": "If Other, please further specify IRB/IEC meeting frequency _184",
"enableIf": "{How often does your Local IRB/IEC meet? _204} = \"Other\"",
"isRequired": true,
"qstRecId": "184",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "How long before Local IRB/IEC meetings must you submit protocol documents?",
"visibleIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"title": "How long before Local IRB/IEC meetings must you submit protocol documents?",
"enableIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"isRequired": true,
"qstRecId": "14",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["7 days", "8 – 14 days", "15 – 21 days", "22 – 28 days", "> 28 days"]
}, {
"type": "text",
"name": "If more than 28 days for document submission, please specify number of days.1",
"visibleIf": "{How long before Local IRB/IEC meetings must you submit protocol documents?} = \"> 28 days\"",
"startWithNewLine": false,
"title": "If more than 28 days for document submission, please specify number of days.",
"valueName": "If more than 28 days for document submission, please specify number of days 1",
"enableIf": "{How long before Local IRB/IEC meetings must you submit protocol documents?} = \"> 28 days\"",
"isRequired": true,
"qstRecId": "23",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "What is the average time from the Local IRB/IEC meeting to having approval documentation in hand?",
"visibleIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"title": "What is the average time from the Local IRB/IEC meeting to having approval documentation in hand?",
"enableIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"isRequired": true,
"qstRecId": "190",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["7 days", "8 – 14 days", "15 – 21 days", "22 – 28 days", "> 28 days"]
}, {
"type": "text",
"name": "If more than 28 days for approval, please specify number of days.",
"visibleIf": "{What is the average time from the Local IRB/IEC meeting to having approval documentation in hand?} = \"> 28 days\"",
"startWithNewLine": false,
"title": "If more than 28 days for approval, please specify number of days.",
"valueName": "If more than 28 days for approval, please specify number of days",
"enableIf": "{What is the average time from the Local IRB/IEC meeting to having approval documentation in hand?} = \"> 28 days\"",
"isRequired": true,
"qstRecId": "170",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "What is expected turnaround time on ICF reviews in preparation for IRB/IEC submissions?_1597257778710",
"visibleIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"title": "What is expected turnaround time on ICF reviews in preparation for IRB/IEC submissions?",
"enableIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"isRequired": true,
"qstRecId": 1597257778710,
"questionType": "Picklist",
"choices": ["7 days", "8 - 14 days", "15 - 21 days", "22 - 28 days", "> 28 days"]
}, {
"type": "text",
"name": "If more than 28 days for ICF review turnaround time, please specify number of days._1597327040899",
"visibleIf": "{What is expected turnaround time on ICF reviews in preparation for IRB/IEC submissions?_1597257778710} = \"> 28 days\"",
"startWithNewLine": false,
"title": "If more than 28 days for ICF review turnaround time, please specify number of days.",
"valueName": "If more than 28 days for ICF review turnaround time, please specify number of days _1597327040899",
"enableIf": "{What is expected turnaround time on ICF reviews in preparation for IRB/IEC submissions?_1597257778710} = \"> 28 days\"",
"isRequired": true,
"qstRecId": 1597327040899,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Does the Local IRB/IEC require a fully executed Clinical Trial Agreement prior to reviewing protocol/consent?_31",
"visibleIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"title": "Does the Local IRB/IEC require a fully executed Clinical Trial Agreement prior to reviewing protocol/consent?",
"enableIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"isRequired": true,
"qstRecId": "31",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "Does the Local IRB/IEC require a fully executed Clinical Trial Agreement prior to releasing Local IRB approval documentation? _188",
"visibleIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"title": "Does the Local IRB/IEC require a fully executed Clinical Trial Agreement prior to releasing Local IRB approval documentation? ",
"enableIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"isRequired": true,
"qstRecId": "188",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "Does the Local IRB/IEC allow expedited approval for minor changes? ",
"visibleIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"title": "Does the Local IRB/IEC allow expedited approval for minor changes? ",
"enableIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"isRequired": true,
"qstRecId": "205",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Which documents are required for Local IRB/IEC submission? (laboratory manual, etc) Enter N/A if there are no specific document requirements._1597258114990",
"visibleIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"title": "Which documents are required for Local IRB/IEC submission? (laboratory manual, etc) Enter N/A if there are no specific document requirements.",
"valueName": "Which documents are required for Local IRB/IEC submission? (laboratory manual, etc) Enter N/A if there are no specific document requirements _1597258114990",
"enableIf": "{Will your site use a Central or Local IRB for this study?_1597256953819} = \"Local\"",
"isRequired": true,
"qstRecId": 1597258114990,
"questionType": "Text"
}],
"visibleIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"United States/US Territories subject to FDA regulations and Canada\"",
"title": "Central and/or Local Institutional Review Boards / Independent Ethics Committees (United States/Canada) Please make sure an IRB/IEC contact is added to the Site Staff tab along with their contact information."
}, {
"type": "panel",
"name": "Central and/or Local Ethics Committees (Europe) Please make sure an IRB/IEC contact is added to the Site Staff tab along with their contact information.",
"elements": [{
"type": "checkbox",
"name": "Which Ethics Committees (ECs) must approve the study before you can start? Please select all that apply.",
"visibleIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"title": "Which Ethics Committees (ECs) must approve the study before you can start? Please select all that apply.",
"valueName": "Which IRB or Ethic Committees (IECs) must approve the study before you can start? Please tick all that apply [Select all that apply]",
"enableIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"isRequired": true,
"qstRecId": "197",
"isFromLib": true,
"questionType": "Multi-picklist",
"choices": ["Local IRB/IEC", "Central IRB/IEC", "Coordinating IEC"]
}, {
"type": "dropdown",
"name": "How often does your Local IRB/IEC meet? _204",
"visibleIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"title": "How often does your Local IRB/IEC meet? ",
"enableIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"isRequired": true,
"qstRecId": "204",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["Weekly", "Twice a month", "Monthly", "As needed", "Other"]
}, {
"type": "text",
"name": "Please further specify IRB/IEC meeting frequency._184",
"visibleIf": "{How often does your Local IRB/IEC meet? _204} = \"Other\"",
"startWithNewLine": false,
"title": "Please further specify IRB/IEC meeting frequency.",
"valueName": "Please further specify IRB/IEC meeting frequency _184",
"enableIf": "{How often does your Local IRB/IEC meet? _204} = \"Other\"",
"qstRecId": "184",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "How long before Local IRB/IEC meetings must you submit protocol documents?_14",
"visibleIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"title": "How long before Local IRB/IEC meetings must you submit protocol documents?",
"enableIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"isRequired": true,
"qstRecId": "14",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["7 days", "8 – 14 days", "15 – 21 days", "22 – 28 days", "> 28 days"]
}, {
"type": "text",
"name": "If more than 28 days for document submission, please specify number of days._23",
"visibleIf": "{How long before Local IRB/IEC meetings must you submit protocol documents?_14} = \"> 28 days\"",
"startWithNewLine": false,
"title": "If more than 28 days for document submission, please specify number of days.",
"valueName": "If more than 28 days for document submission, please specify number of days _23",
"enableIf": "{How long before Local IRB/IEC meetings must you submit protocol documents?_14} = \"> 28 days\"",
"isRequired": true,
"qstRecId": "23",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "What is the average time from the Local IRB/IEC meeting to having approval documentation in hand?_190",
"visibleIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"title": "What is the average time from the Local IRB/IEC meeting to having approval documentation in hand?",
"enableIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"isRequired": true,
"qstRecId": "190",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["7 days", "8 – 14 days", "15 – 21 days", "22 – 28 days", "> 28 days"]
}, {
"type": "text",
"name": "If more than 28 days for approval, please specify number of days.1",
"visibleIf": "{What is the average time from the Local IRB/IEC meeting to having approval documentation in hand?_190} = \"> 28 days\"",
"startWithNewLine": false,
"title": "If more than 28 days for approval, please specify number of days.",
"valueName": "If more than 28 days for approval, please specify number of days 1",
"enableIf": "{What is the average time from the Local IRB/IEC meeting to having approval documentation in hand?_190} = \"> 28 days\"",
"isRequired": true,
"qstRecId": "170",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Does the Local IRB/IEC allow expedited approval for minor changes? 1",
"visibleIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"title": "Does the Local IRB/IEC allow expedited approval for minor changes? ",
"enableIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"isRequired": true,
"qstRecId": "205",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "Does the Local IRB/IEC require a fully executed Clinical Trial Agreement prior to reviewing protocol/consent?",
"visibleIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"title": "Does the Local IRB/IEC require a fully executed Clinical Trial Agreement prior to reviewing protocol/consent?",
"enableIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"isRequired": true,
"qstRecId": "31",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "radiogroup",
"name": "Does the Local IRB/IEC require a fully executed Clinical Trial Agreement prior to releasing Local EC approval documentation?",
"visibleIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"title": "Does the Local IRB/IEC require a fully executed Clinical Trial Agreement prior to releasing Local EC approval documentation?",
"enableIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"isRequired": true,
"qstRecId": "188",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Which documents are required for local EC submission? (laboratory manual, etc) Enter N/A if there are no specific document requirements._1597259992902",
"visibleIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"title": "Which documents are required for local EC submission? (laboratory manual, etc) Enter N/A if there are no specific document requirements.",
"valueName": "Which documents are required for local EC submission? (laboratory manual, etc) Enter N/A if there are no specific document requirements _1597259992902",
"enableIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"isRequired": true,
"qstRecId": 1597259992902,
"questionType": "Text"
}],
"visibleIf": "{Please select your region to be directed to the relevant questions regarding start-up requirements:_1597326206229} = \"Europe/Asia-pacific/Africa/Latin America\"",
"title": "Central and/or Local Ethics Committees (Europe) Please make sure an IRB/IEC contact is added to the Site Staff tab along with their contact information."
}],
"title": "Regional Start-up Requirements"
}, {
"name": "Additional Review Departments/Committees",
"elements": [{
"type": "radiogroup",
"name": "Are there any other departments/committees involved in the protocol review process? ",
"title": "Are there any other departments/committees involved in the protocol review process? ",
"qstRecId": "189",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "dropdown",
"name": "Do these additional department/committee procedures affect the contract and budget approvals? _203",
"visibleIf": "{Are there any other departments/committees involved in the protocol review process? } = \"Yes\"",
"title": "Do these additional department/committee procedures affect the contract and budget approvals? ",
"qstRecId": "203",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["No", "Yes"]
}, {
"type": "text",
"name": "Please explain affect on contract and budget approvals.",
"visibleIf": "{Do these additional department/committee procedures affect the contract and budget approvals? _203} = \"Yes\"",
"startWithNewLine": false,
"title": "Please explain affect on contract and budget approvals.",
"valueName": "Please explain affect on contract and budget approvals",
"qstRecId": "15",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "panel",
"name": "Department/Committee #1",
"elements": [{
"type": "text",
"name": "Please indicate name of department/committee #1:",
"title": "Please indicate name of department/committee #1:",
"enableIf": "{Are there any other departments/committees involved in the protocol review process? } = \"Yes\"",
"qstRecId": "198",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "How often does department/committee #1 meet?",
"title": "How often does department/committee #1 meet?",
"enableIf": "{Are there any other departments/committees involved in the protocol review process? } = \"Yes\"",
"qstRecId": "206",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["Weekly", "Twice a month", "Monthly", "Other"]
}, {
"type": "text",
"name": "Please specify meeting frequency of department/committee #1.",
"visibleIf": "{How often does department/committee #1 meet?} = \"Other\"",
"startWithNewLine": false,
"title": "Please specify meeting frequency of department/committee #1.",
"valueName": "Please specify meeting frequency of department/committee #1",
"qstRecId": "22",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "How much lead time does department/committee #1 require for submitting documents?",
"title": "How much lead time does department/committee #1 require for submitting documents?",
"enableIf": "{Are there any other departments/committees involved in the protocol review process? } = \"Yes\"",
"qstRecId": "172",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["< 2 weeks", "2 weeks", "2 weeks to 1 month", "1 to 2 months", ">2 months", "Other"]
}, {
"type": "text",
"name": "Please specify lead time for submitting documents for department/committee #1.",
"visibleIf": "{How much lead time does department/committee #1 require for submitting documents?} = \"Other\" or {How much lead time does department/committee #1 require for submitting documents?} = \">2 months\"",
"startWithNewLine": false,
"title": "Please specify lead time for submitting documents for department/committee #1.",
"valueName": "Please specify lead time for submitting documents for department/committee #1",
"enableIf": "{How much lead time does department/committee #1 require for submitting documents?} = \"Other\" or {How much lead time does department/committee #1 require for submitting documents?} = \">2 months\"",
"qstRecId": "12",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "What is the average time from the department/committee #1 meeting to having approval documentation in hand?",
"title": "What is the average time from the department/committee #1 meeting to having approval documentation in hand?",
"enableIf": "{Are there any other departments/committees involved in the protocol review process? } = \"Yes\"",
"qstRecId": "196",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["< 2 weeks", "2 weeks", "2 weeks to 1 month", "1 to 2 months", ">2 months", "Other"]
}, {
"type": "text",
"name": "Please specify average time from meeting to approval for department/committee #1._6",
"visibleIf": "{What is the average time from the department/committee #1 meeting to having approval documentation in hand?} = \">2 months\" or {What is the average time from the department/committee #1 meeting to having approval documentation in hand?} = \"Other\"",
"startWithNewLine": false,
"title": "Please specify average time from meeting to approval for department/committee #1.",
"valueName": "Please specify average time from meeting to approval for department/committee #1 _6",
"enableIf": "{What is the average time from the department/committee #1 meeting to having approval documentation in hand?} = \">2 months\" or {What is the average time from the department/committee #1 meeting to having approval documentation in hand?} = \"Other\"",
"qstRecId": "6",
"isFromLib": true,
"questionType": "Text"
}],
"visibleIf": "{Are there any other departments/committees involved in the protocol review process? } = \"Yes\"",
"title": "Department/Committee #1"
}, {
"type": "panel",
"name": "Department/Committee #2",
"elements": [{
"type": "text",
"name": "Please indicate name of department/committee #2:",
"title": "Please indicate name of department/committee #2:",
"qstRecId": "19",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "How often does department/committee #2 meet?",
"title": "How often does department/committee #2 meet?",
"qstRecId": "175",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["Weekly", "Twice a month", "Monthly", "Other"]
}, {
"type": "text",
"name": "Please specify meeting frequency of department/committee #2.",
"visibleIf": "{How often does department/committee #2 meet?} = \"Other\"",
"startWithNewLine": false,
"title": "Please specify meeting frequency of department/committee #2.",
"valueName": "Please specify meeting frequency of department/committee #2",
"qstRecId": "5",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "How much lead time does department/committee #2 require for submitting documents?",
"title": "How much lead time does department/committee #2 require for submitting documents?",
"qstRecId": "194",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["< 2 weeks", "2 weeks", "2 weeks to 1 month", "1 to 2 months", ">2 months", "Other"]
}, {
"type": "text",
"name": "Please specify lead time for submitting documents for department/committee #2.",
"visibleIf": "{How much lead time does department/committee #2 require for submitting documents?} = \"Other\" or {How much lead time does department/committee #2 require for submitting documents?} = \">2 months\"",
"startWithNewLine": false,
"title": "Please specify lead time for submitting documents for department/committee #2.",
"valueName": "Please specify lead time for submitting documents for department/committee #2",
"enableIf": "{How much lead time does department/committee #2 require for submitting documents?} = \"Other\" or {How much lead time does department/committee #2 require for submitting documents?} = \">2 months\"",
"qstRecId": "13",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "What is the average time from the department/committee #2 meeting to having approval documentation in hand?",
"title": "What is the average time from the department/committee #2 meeting to having approval documentation in hand?",
"qstRecId": "185",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["< 2 weeks", "2 weeks", "2 weeks to 1 month", "1 to 2 months", ">2 months", "Other"]
}, {
"type": "text",
"name": "Please specify average time from meeting to approval for department/committee #2._7",
"visibleIf": "{What is the average time from the department/committee #2 meeting to having approval documentation in hand?} = \">2 months\" or {What is the average time from the department/committee #2 meeting to having approval documentation in hand?} = \"Other\"",
"startWithNewLine": false,
"title": "Please specify average time from meeting to approval for department/committee #2.",
"valueName": "Please specify average time from meeting to approval for department/committee #2 _7",
"enableIf": "{What is the average time from the department/committee #2 meeting to having approval documentation in hand?} = \">2 months\" or {What is the average time from the department/committee #2 meeting to having approval documentation in hand?} = \"Other\"",
"qstRecId": "7",
"isFromLib": true,
"questionType": "Text"
}],
"visibleIf": "{Are there any other departments/committees involved in the protocol review process? } = \"Yes\"",
"title": "Department/Committee #2"
}, {
"type": "panel",
"name": "Department/Committee #3",
"elements": [{
"type": "text",
"name": "Please indicate name of department/committee #3:",
"title": "Please indicate name of department/committee #3:",
"qstRecId": "20",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "How often does department/committee #3 meet?",
"title": "How often does department/committee #3 meet?",
"qstRecId": "193",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["Weekly", "Twice a month", "Monthly", "Other"]
}, {
"type": "text",
"name": "Please specify meeting frequency of department/committee #3.",
"visibleIf": "{How often does department/committee #3 meet?} = \"Other\"",
"startWithNewLine": false,
"title": "Please specify meeting frequency of department/committee #3.",
"valueName": "Please specify meeting frequency of department/committee #3",
"qstRecId": "21",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "How much lead time does department/committee #3 require for submitting documents?",
"title": "How much lead time does department/committee #3 require for submitting documents?",
"qstRecId": "207",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["< 2 weeks", "2 weeks", "2 weeks to 1 month", "1 to 2 months", ">2 months", "Other"]
}, {
"type": "text",
"name": "Please specify lead time for submitting documents for department/committee #3.",
"visibleIf": "{How much lead time does department/committee #3 require for submitting documents?} = \"Other\" or {How much lead time does department/committee #3 require for submitting documents?} = \">2 months\"",
"startWithNewLine": false,
"title": "Please specify lead time for submitting documents for department/committee #3.",
"valueName": "Please specify lead time for submitting documents for department/committee #3",
"enableIf": "{How much lead time does department/committee #3 require for submitting documents?} = \"Other\" or {How much lead time does department/committee #3 require for submitting documents?} = \">2 months\"",
"qstRecId": "11",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "What is the average time from the department/committee #3 meeting to having approval documentation in hand?",
"title": "What is the average time from the department/committee #3 meeting to having approval documentation in hand?",
"qstRecId": "195",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["< 2 weeks", "2 weeks", "2 weeks to 1 month", "1 to 2 months", ">2 months", "Other"]
}, {
"type": "text",
"name": "Please specify average time from meeting to approval for department/committee #3._3",
"visibleIf": "{What is the average time from the department/committee #3 meeting to having approval documentation in hand?} = \">2 months\" or {What is the average time from the department/committee #3 meeting to having approval documentation in hand?} = \"Other\"",
"startWithNewLine": false,
"title": "Please specify average time from meeting to approval for department/committee #3.",
"valueName": "Please specify average time from meeting to approval for department/committee #3 _3",
"enableIf": "{What is the average time from the department/committee #3 meeting to having approval documentation in hand?} = \">2 months\" or {What is the average time from the department/committee #3 meeting to having approval documentation in hand?} = \"Other\"",
"qstRecId": "3",
"isFromLib": true,
"questionType": "Text"
}],
"visibleIf": "{Are there any other departments/committees involved in the protocol review process? } = \"Yes\"",
"title": "Department/Committee #3"
}],
"title": "Additional Review Departments/Committees"
}, {
"name": "Contracts and Trial Agreements",
"elements": [{
"type": "panel",
"name": "Please make sure contract and budget contacts are added to the Site Staff tab along with their contact information.",
"elements": [{
"type": "dropdown",
"name": "If you are selected to be National Coordinating Investigator (NCI), how quickly can your site begin NCI negotiations?_179",
"title": "If you are selected to be National Coordinating Investigator (NCI), how quickly can your site begin NCI negotiations?",
"isRequired": true,
"qstRecId": "179",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["< 4 weeks", "4 – 8 weeks", "8 – 12 weeks", "12 – 16 weeks", ">16 weeks"]
}, {
"type": "text",
"name": "Please specify how quickly can your site begin NCI negotiations._180",
"title": "Please specify how quickly can your site begin NCI negotiations.",
"valueName": "Please specify how quickly can your site begin NCI negotiations _180",
"isRequired": true,
"qstRecId": "180",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "Is a separate NCI agreement required or may a section regarding the NCI role be incorporated into the Clinical Trial Agreement? _177",
"title": "Is a separate NCI agreement required or may a section regarding the NCI role be incorporated into the Clinical Trial Agreement? ",
"isRequired": true,
"qstRecId": "177",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["Separate NCI agreement required", "Section regarding the NCI role will be incorporated into the Clinical Trial Agreement", "Unknown"]
}, {
"type": "dropdown",
"name": "If you have previously worked with the Sponsor, are you willing to clone the previously-negotiated language and budget fees?_178",
"title": "If you have previously worked with the Sponsor, are you willing to clone the previously-negotiated language and budget fees?",
"isRequired": true,
"qstRecId": "178",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["Not worked with Sponsor previously", "Yes", "No", "Unknown"]
}, {
"type": "text",
"name": "Please identify if there are any processes that are required prior to working on the contract and budget._1597261587355",
"title": "Please identify if there are any processes that are required prior to working on the contract and budget.",
"valueName": "Please identify if there are any processes that are required prior to working on the contract and budget _1597261587355",
"qstRecId": 1597261587355,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Are there any advance/start up fees to be paid before negotiations can begin? ",
"title": "Are there any advance/start up fees to be paid before negotiations can begin? ",
"isRequired": true,
"qstRecId": "191",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Specify any advance/start up fees to be paid before negotiations can begin.",
"visibleIf": "{Are there any advance/start up fees to be paid before negotiations can begin? } = \"Yes\"",
"startWithNewLine": false,
"title": "Specify any advance/start up fees to be paid before negotiations can begin.",
"valueName": "Specify any advance/start up fees to be paid before negotiations can begin",
"enableIf": "{Are there any advance/start up fees to be paid before negotiations can begin? } = \"Yes\"",
"isRequired": true,
"qstRecId": "187",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Does your site require a final budget or fully-executed Clinical Trial Agreement before IRB/EC submission? ",
"title": "Does your site require a final budget or fully-executed Clinical Trial Agreement before IRB/EC submission? ",
"qstRecId": "199",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Specify which is required (final budget or fully executed CTA) or indicate both.",
"visibleIf": "{Does your site require a final budget or fully-executed Clinical Trial Agreement before IRB/EC submission? } = \"Yes\"",
"startWithNewLine": false,
"title": "Specify which is required (final budget or fully executed CTA) or indicate both.",
"valueName": "Specify which is required (final budget or fully executed CTA) or indicate both",
"enableIf": "{Does your site require a final budget or fully-executed Clinical Trial Agreement before IRB/EC submission? } = \"Yes\"",
"qstRecId": "200",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Do you need IRB/EC submission or approval before contract negotiations can start?",
"title": "Do you need IRB/EC submission or approval before contract negotiations can start?",
"qstRecId": "192",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Specify which is required (submission or approval). ",
"visibleIf": "{Do you need IRB/EC submission or approval before contract negotiations can start?} = \"Yes\"",
"startWithNewLine": false,
"title": "Specify which is required (submission or approval). ",
"valueName": "Specify which is required (submission or approval)",
"enableIf": "{Do you need IRB/EC submission or approval before contract negotiations can start?} = \"Yes\"",
"qstRecId": "301",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Does your site require a fully executed CTA prior to working on regulatory documents?_1597261763876",
"title": "Does your site require a fully executed CTA prior to working on regulatory documents?",
"qstRecId": 1597261763876,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "dropdown",
"name": "What is your best estimate for the contract negotiation timeframes at your site?",
"title": "What is your best estimate for the contract negotiation timeframes at your site?",
"isRequired": true,
"qstRecId": "176",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["< 4 weeks", "4 – 8 weeks", "8 – 12 weeks", "12 – 16 weeks", ">16 weeks"]
}, {
"type": "text",
"name": "Please specify duration of the contract negotiation timeframes at your site.",
"visibleIf": "{What is your best estimate for the contract negotiation timeframes at your site?} = \">16 weeks\"",
"startWithNewLine": false,
"title": "Please specify duration of the contract negotiation timeframes at your site.",
"valueName": "Please specify duration of the contract negotiation timeframes at your site",
"enableIf": "{What is your best estimate for the contract negotiation timeframes at your site?} = \">16 weeks\"",
"isRequired": true,
"qstRecId": "28",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "radiogroup",
"name": "Are any other contract approvals required?",
"title": "Are any other contract approvals required?",
"isRequired": true,
"qstRecId": "174",
"isFromLib": true,
"questionType": "Yes/No",
"choices": ["Yes", "No"]
}, {
"type": "text",
"name": "Please specify any other contract approvals required.",
"visibleIf": "{Are any other contract approvals required?} = \"Yes\"",
"startWithNewLine": false,
"title": "Please specify any other contract approvals required.",
"valueName": "Please specify any other contract approvals required",
"enableIf": "{Are any other contract approvals required?} = \"Yes\"",
"isRequired": true,
"qstRecId": "181",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "How long is the signature process from the time that the contract and budget are finalized? ",
"title": "How long is the signature process from the time that the contract and budget are finalized? ",
"isRequired": true,
"qstRecId": "173",
"isFromLib": true,
"questionType": "Picklist",
"choices": ["< 3 days", "3 – 7 days", "1 – 2 weeks", "2 – 3 weeks", ">3 weeks"]
}, {
"type": "text",
"name": "Please specify duration of the signature process from the time that the contract and budget are finalized.",
"visibleIf": "{How long is the signature process from the time that the contract and budget are finalized? } = \">3 weeks\"",
"startWithNewLine": false,
"title": "Please specify duration of the signature process from the time that the contract and budget are finalized.",
"valueName": "Please specify duration of the signature process from the time that the contract and budget are finalized",
"enableIf": "{How long is the signature process from the time that the contract and budget are finalized? } = \">3 weeks\"",
"isRequired": true,
"qstRecId": "24",
"isFromLib": true,
"questionType": "Text"
}, {
"type": "dropdown",
"name": "Please indicate the overall expected timelines to study commencement (including all administrative, legal/contractual and governance approval)._1597262264496",
"title": "Please indicate the overall expected timelines to study commencement (including all administrative, legal/contractual and governance approval).",
"valueName": "Please indicate the overall expected timelines to study commencement (including all administrative, legal/contractual and governance approval) _1597262264496",
"qstRecId": 1597262264496,
"questionType": "Picklist",
"choices": ["< 3 months", "4 – 6 months", "7 – 9 months", "10 – 12 months", "> 12 months"]
}],
"title": "Please make sure contract and budget contacts are added to the Site Staff tab along with their contact information."
}],
"title": "Contracts and Trial Agreements"
}, {
"name": "Additional Information",
"elements": [{
"type": "text",
"name": "Include any additional institution steps (if not already addressed) that must be completed prior to activation._1597865460700",
"title": "Include any additional institution steps (if not already addressed) that must be completed prior to activation.",
"valueName": "Include any additional institution steps (if not already addressed) that must be completed prior to activation _1597865460700",
"qstRecId": 1597865460700,
"questionType": "Text"
}],
"title": "Additional Information"
}],
"showProgressBar": "top",
"completeText": "Submit for Review"
}