Structure LinkId Text Cardinality Type Flags Description & Constraints SIRBInitiateAStudyQuestionnaire Initiate a Study Questionnaire Questionnaire http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire-populate#1.0.0 in1 Research Study Details 0..1 group in1.1 Study Title 1..1 string in1.1_help The official title of a protocol used to identify a clinical study.Include phase (e.g. pilot proof of concept study, phase I, phase II, etc.), design (e.g. randomized, double blind, placebo controlled, etc.), if the study is multi-center, the investigational agent (drug, device, biologic, vaccine, procedural and/or behavioral etc., and target disease(s) 0..1 display in1.2 Study Title (Short) 1..1 string in1.2_help A short study title written in language intended for the lay public. 0..1 display in1.3 IRB Protocol Number 1..1 string in1.3_help The Protocol Number assigned by the sIRB 0..1 display in1.4 Study Type 1..1 choice Options: 2 options in1.4_help Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional) 0..1 display DIVIDER1 null 0..1 display in5 Other Organization(s) Involved 0..* group in5.1 Relationship Type 1..1 choice Options: 2 options in5.1_help Select the organization's type of involvement in the study 0..1 display in5.2 Organization Name 1..1 string in5.2_help e.g. NIH or company name 0..1 display in5.3 Phone 0..1 string in5.3_help 10 digit phone number, including area code 0..1 display in5.4 Sponsor or Funding Source Protocol Number, if applicable 0..1 string in5.4_help Unique Protocol Identification Number used by the sponsor, if applicable 0..1 display in5.5 Other Organization Name, Relationship Type, Phone and Protocol Number (read-only) 0..1 string Expressions: Calculated Value: %combinedOtherOrgUniqueOneRepetition in5.6 Protocol Number with Organization Name (read-only) 0..1 string Expressions: Calculated Value: %otherOrgProtocolWithNameOneRepetition DIVIDER2 null 0..1 display in6 sIRB (Reviewing Institution) 0..1 group in6.1 sIRB (Reviewing Institution) Name 1..1 string in6.1_help Name of the sIRB (Reviewing Institution) 0..1 display in6.10 Department Name or Division 0..1 string in6.10_help The department name or division of the sIRB, if applicable 0..1 display in6.3 Institution Street Address 1..1 string in6.3_help Physical address of the sIRB (Reviewing Institution) 0..1 display in6.4 Institution City 1..1 string in6.5 Institution State 1..1 string in6.6 Institution Zip Code 1..1 string in6.7 Institution Country 0..1 string Initial Value: string = United States in6.8 Is a Federal Wide Assurance (FWA) Number assigned? 1..1 choice Options: 4 options in6.8_help DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information". 0..1 display in6.9 Federal Wide Assurance Number (if assigned) 0..1 integer Enable When: in6.8 = Yes (expandedYes-NoIndicator#Y) in6.9_help If assigned, enter just numeric value of FWA. 0..1 display in6.11 Is the sIRB a 3rd party institution? 0..1 choice Options: 2 options in6.11_help Is the sIRB an external 3rd party institution, outside of the lead Principal Investigator institution? 0..1 display DIVIDER3 null 0..1 display in7 Lead Principal Investigator 0..1 group in7.1 Lead Principal Investigator Institution 0..1 group in7.1.1 Lead Principal Investigator Institution Name 1..1 string in7.1.1_help Name of institution for the lead principal investigator 0..1 display in7.1.10 Department Name or Division 0..1 string in7.1.10_help The department name or division of the lead principal investigator 0..1 display in7.1.3 Institution Phone 0..1 string in7.1.3_help 10-digit phone number, including area code, for the institution of the lead principal investigator 0..1 display in7.1.4 Is a Federal Wide Assurance (FWA) Number assigned? 1..1 choice Options: 4 options in7.1.4_help DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information". 0..1 display in7.1.5 Federal Wide Assurance Number (if assigned) 0..1 integer Enable When: in7.1.4 = Yes (expandedYes-NoIndicator#Y) in7.1.5_help If assigned, enter just numeric value of FWA. 0..1 display in7.3 Lead Principal Investigator 0..1 group in7.3.1 Lead Principal Investigator First Name 1..1 string in7.3.1_help First Name or Given Name of the lead PI responsible for the overall study 0..1 display in7.3.2 Lead Principal Investigator Last Name 1..1 string in7.3.2_help Last name, surname or family name of the lead PI responsible for the overall study 0..1 display in7.3.3 Lead Principal Investigator Suffix 0..1 string in7.3.3_help Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. 0..1 display in7.3.4 Academic and Professional Degrees associated with the Lead Principal Investigator 1..1 string in7.3.4_help Academic and Professional degrees associated with the lead principal investigator 0..1 display in7.3.10 Department Name or Division 0..1 string in7.3.10_help The department name or division of the lead PI 0..1 display in7.3.5 Phone 0..1 string in7.3.5_help 10-digit phone number, including area code, for the lead principal investigator 0..1 display in7.3.6 Email address 0..1 string in7.3.6_help Email address associated with the lead principal investigator 0..1 display in7.3.7 Address of Lead Principal Investigator 0..1 group in7.3.7.1 Street Address 0..1 string in7.3.7.1_help Physical address 0..1 display in7.3.7.2 City 1..1 string in7.3.7.3 State 1..1 string in7.3.7.4 Zip Code 0..1 string in7.3.7.5 Country 0..1 string Initial Value: string = United States in7.9 Lead Principal Investigator Unique Site (read-only) 0..1 string Expressions: Calculated Value: %combinedLeadPIUniqueSite in7.10 Lead Principal Investigator Full Name, Suffix and Degrees 0..1 string Expressions: Calculated Value: %fullNameDSLeadPI DIVIDER4 null 0..1 display in8 Relying Site(s) 0..* group in8.5 Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator 0..1 group in8.5.1 Is this relying site at the same institution as where the lead principal investigator is conducting the study? 0..1 choice Options: 2 options in8.5.1_help This question is optional. It can be used to pre-populate the lead principal investigator institution details if this relying site is at the same institution as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank. 0..1 display in8.5.2 Is this relying site at the same site as where the lead principal investigator is conducting the study? 0..1 choice Enable When: in8.5.1 = Yes (expandedYes-NoIndicator#Y) Options: 2 options in8.5.2_help This question is optional. It can be used to pre-populate the lead principal investigator site details if this relying site is at the same site as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank. 0..1 display in8.5.3 Is the relying site PI for this site the same PI as the lead principal investigator conducting the study? 0..1 choice Options: 2 options in8.5.3_help This question is optional. It can be used to pre-populate the lead principal investigator details if this relying site PI is the same PI as the lead principal investigator conducting the study. If you do not want pre-population to occur, you may leave this question blank. 0..1 display in8.5.4 Is this relying site also considered to be the lead site for the study? 1..1 choice Options: 2 options in8.5.4_help Indicator that the lead PI site where the study is being conducted is also participating as this relying site 0..1 display in8.1 Relying Site Institution 0..1 group in8.1.1 Relying Institution Name 1..1 string Expressions: Calculated Value: iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.1').answer.value) in8.1.1_help Name of Institution for which their IRB agrees to rely on the decisions of the reviewing IRB at their own institutions. 0..1 display in8.1.10 Department Name or Division 0..1 string Expressions: Calculated Value: iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.10').answer.value) in8.1.10_help The department name or division for the relying site 0..1 display in8.1.3 Relying Institution Phone 0..1 string Expressions: Calculated Value: iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.3').answer.value) in8.1.3_help 10-digit phone number, including area code, for the relying institution 0..1 display in8.1.4 Is a Federal Wide Assurance (FWA) Number assigned? 1..1 choice Options: 4 options Expressions: Calculated Value: iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.4').answer.valueCoding) in8.1.4_help DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information". 0..1 display in8.1.5 Federal Wide Assurance Number (if assigned) 0..1 integer Enable When: in8.1.4 = Yes (expandedYes-NoIndicator#Y) Expressions: Calculated Value: iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.5').answer.value) in8.1.5_help If assigned, enter just numeric value of FWA. 0..1 display in8.1.6 Reliance Status 1..1 choice Options: 5 options in8.1.6_help Status of the reliance agreement 0..1 display in8.1_help Institution whose IRB agrees to rely on oversite by the sIRB (Reviewing IRB) 0..1 display in8.3 Relying Site Principal Investigator 0..1 group in8.3.1 Relying Site Principal Investigator First Name 1..1 string Expressions: Calculated Value: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.1').answer.value) in8.3.1_help First Name or Given Name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution 0..1 display in8.3.2 Relying Site Principal Investigator Last Name 1..1 string Expressions: Calculated Value: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.2').answer.value) in8.3.2_help Last name, surname or family name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution 0..1 display in8.3.3 Relying Site Principal Investigator Suffix 0..1 string Expressions: Calculated Value: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.3').answer.value) in8.3.3_help Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. 0..1 display in8.3.4 Academic and Professional Degrees associated with the Relying Site Principal Investigator 0..1 string Expressions: Calculated Value: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.4').answer.value) in8.3.4_help Academic and Professional degrees associated with the relying site principal investigator 0..1 display in8.3.10 Department Name or Division 0..1 string Expressions: Calculated Value: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.10').answer.value) in8.3.10_help The department name or division for the relying site PI 0..1 display in8.3.5 Phone 0..1 string Expressions: Calculated Value: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.5').answer.value) in8.3.5_help 10-digit phone number, including area code, for the relying site principal investigator 0..1 display in8.3.6 Email address 0..1 string Expressions: Calculated Value: iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.6').answer.value) in8.3.6_help Email address associated with the relying site principal investigator 0..1 display in8.3.7 Address of Relying Site Principal Investigator 0..1 group in8.3.7.1 Street Address 0..1 string Expressions: Calculated Value: iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.1').answer.value) in8.3.7.1_help Physical address 0..1 display in8.3.7.2 City 0..1 string Expressions: Calculated Value: iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.2').answer.value) in8.3.7.3 State 0..1 string Expressions: Calculated Value: iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.3').answer.value) in8.3.7.4 Zip Code 0..1 string Expressions: Calculated Value: iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.4').answer.value) in8.3.7.5 Country 0..1 string Initial Value: string = United States in8.3_help Principal Investigator responsible for the conduct of the study at a specific relying site research location. 0..1 display in8.9 Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only) 0..1 string Expressions: Calculated Value: %combinedSitePIUniqueSiteOneRepetition in8.10 Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only) 0..1 string Expressions: Calculated Value: %fullNameDSSitePIOneRepetition in8_help The research site(s) where the Lead Principal Investigator is conducting research should also be entered as relying site(s) here, even if at the same institution as entered above for the Lead Principal Investigator. If the Lead Principal Investigator is only managing a coordinating center or other administrative office for the study, do not enter the site again here. 0..1 display DIVIDER5 null 0..1 display in9 FDA exemption and IDE/IND Number 0..1 group in9.1 Does this study require a FDA exemption? 0..1 choice Options: 2 options in9.1_help Indicator for use of FDA regulated product 0..1 display in9.2 Is an IND or IDE being used in this study? 0..1 choice Options: 2 options in9.2_help Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used? 0..1 display in9.4 Please select IND or IDE: 0..1 choice Enable When: in9.2 = Yes (expandedYes-NoIndicator#Y) Options: 2 options in9.4_help Select IND for Investigational New Drug or IDE for Investigational Device Exemption 0..1 display in9.3 IND/IDE Number 0..1 string Enable When: in9.2 = Yes (expandedYes-NoIndicator#Y) DIVIDER6 null 0..1 display in10 Questionnaire Version Details 0..1 group in10.1 Questionnaire Version 1..1 string Initial Value: string = 2 in10.2 Questionnaire Version Date 1..1 date Initial Value: date = 2021-10-18 DIVIDER7 null 0..1 display ADMIN00 Administrative Use Only (will be hidden in the future) 0..1 group ADMIN01 Link ID prefix 0..1 string Initial Value: string = in ADMIN02 Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any 0..1 string Initial Value: string = temporarily unavailable ADMIN03 ID of the Research Study FHIR Resource associated with the study Questionnaire Responses 0..1 string Initial Value: string = temporarily unavailable ADMIN04 Questionnaire Response ID of the local considerations Questionnaire Response, if any 0..1 string Documentation for this format Option Sets Answer options for in1.4 http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#INT ("Interventional") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#OBS ("Observational") Answer options for in5.1 http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#SFS ("Sponsor or Funding Source") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#CRO ("Contract Research Organization (CRO)") Answer options for in6.8 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") http://terminology.hl7.org/CodeSystem/v2-0532#NI ("No Information") http://terminology.hl7.org/CodeSystem/v2-0532#NAV ("temporarily unavailable") Answer options for in6.11 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for in7.1.4 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") http://terminology.hl7.org/CodeSystem/v2-0532#NI ("No Information") http://terminology.hl7.org/CodeSystem/v2-0532#NAV ("temporarily unavailable") Answer options for in8.5.1 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for in8.5.2 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for in8.5.3 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for in8.5.4 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for in8.1.4 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") http://terminology.hl7.org/CodeSystem/v2-0532#NI ("No Information") http://terminology.hl7.org/CodeSystem/v2-0532#NAV ("temporarily unavailable") Answer options for in8.1.6 http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#APPROVED ("Approved for reliance") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DENIED ("Denied reliance") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#POSSIBLE ("Potential/possible") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#CANCELLED ("Cancelled or not participating") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#ONHOLD ("Temporarily on hold") Answer options for in9.1 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for in9.2 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for in9.4 http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IND ("IND") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IDE ("IDE")
HL7 International - Biomedical Research and Regulation
The official title of a protocol used to identify a clinical study.Include phase (e.g. pilot proof of concept study, phase I, phase II, etc.), design (e.g. randomized, double blind, placebo controlled, etc.), if the study is multi-center, the investigational agent (drug, device, biologic, vaccine, procedural and/or behavioral etc., and target disease(s)
A short study title written in language intended for the lay public.
The Protocol Number assigned by the sIRB
Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)
iif(item.where(linkId = 'in5.1').answer.valueCoding.display.exists(), item.where(linkId = 'in5.1').answer.valueCoding.display, ' ')
iif(item.where(linkId = 'in5.2').answer.valueString.exists(), item.where(linkId = 'in5.2').answer.valueString, ' ')
iif(item.where(linkId = 'in5.3').answer.valueString.exists(), item.where(linkId = 'in5.3').answer.valueString, ' ')
iif(item.where(linkId = 'in5.4').answer.valueString.exists(), item.where(linkId = 'in5.4').answer.valueString, ' ')
combination of Other Org fields to make unique identifier
%otherOrgNameOneRepetition + ' | ' + %otherOrgPhoneOneRepetition + ' | ' + %otherOrgProtocolOneRepetition + ' | ' + %otherOrgRelTypeOneRepetition
Funding Source/Sponsor Protocol and Funding Source/Sponsor Name
%otherOrgProtocolOneRepetition + ' (' + %otherOrgNameOneRepetition + ')'
Select the organization's type of involvement in the study
10 digit phone number, including area code
Sponsor or Funding Source Protocol Number, if applicable
Unique Protocol Identification Number used by the sponsor, if applicable
Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)
Protocol Number with Organization Name (read-only)
Name of the sIRB (Reviewing Institution)
The department name or division of the sIRB, if applicable
Physical address of the sIRB (Reviewing Institution)
Is a Federal Wide Assurance (FWA) Number assigned?
DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information".
Federal Wide Assurance Number (if assigned)
If assigned, enter just numeric value of FWA.
Is the sIRB an external 3rd party institution, outside of the lead Principal Investigator institution?
iif(%resource.descendants().where(linkId = 'in7.1.1').answer.value.exists(), %resource.descendants().where(linkId = 'in7.1.1').answer.value, ' ')
iif(%resource.descendants().where(linkId = 'in7.1.10').answer.value.exists(), %resource.descendants().where(linkId = 'in7.1.10').answer.value, ' ')
iif(%resource.descendants().where(linkId = 'in7.3.1').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.1').answer.value, ' ')
iif(%resource.descendants().where(linkId = 'in7.3.2').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.2').answer.value, ' ')
iif(%resource.descendants().where(linkId = 'in7.3.3').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.3').answer.value, ' ')
iif(%resource.descendants().where(linkId = 'in7.3.4').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.4').answer.value, ' ')
iif(%resource.descendants().where(linkId = 'in7.3.7.2').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.7.2').answer.value, ' ')
iif(%resource.descendants().where(linkId = 'in7.3.7.3').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.7.3').answer.value, ' ')
full name, suffix and degrees for the lead PI
%leadPIFirstName + ' ' + %leadPILastName + ', ' + iif(%leadPISuffix = ' ', '', %leadPISuffix+ ', ') + %leadPIDegrees
iif(%resource.descendants().where(linkId = 'in7.3.7.2').answer.value.exists(), %leadPICity, ' ') + ', ' + iif(%resource.descendants().where(linkId = 'in7.3.7.3').answer.value.exists(), %leadPIState, ' ')
full name, suffix and degrees for the lead PI with the lead PI institution and lead PI dept
%leadPIInstitutionName + ' | ' + %leadPIDept + ' | ' + %fullNameDSLeadPI + ' | ' + %leadPILocation
Lead Principal Investigator Institution Name
Name of institution for the lead principal investigator
The department name or division of the lead principal investigator
10-digit phone number, including area code, for the institution of the lead principal investigator
First Name or Given Name of the lead PI responsible for the overall study
Last name, surname or family name of the lead PI responsible for the overall study
Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.
Academic and Professional Degrees associated with the Lead Principal Investigator
Academic and Professional degrees associated with the lead principal investigator
The department name or division of the lead PI
10-digit phone number, including area code, for the lead principal investigator
Email address associated with the lead principal investigator
Lead Principal Investigator Unique Site (read-only)
Lead Principal Investigator Full Name, Suffix and Degrees
is this relying site at the lead PI institution
item.descendants().where(linkId = 'in8.5.1').answer.valueCoding.code
is this relying site the same as the lead PI site
item.descendants().where(linkId = 'in8.5.2').answer.valueCoding.code
is this relying site PI the same as the lead PI
item.descendants().where(linkId = 'in8.5.3').answer.valueCoding.code
iif(item.descendants().where(linkId = 'in8.1.1').answer.valueString.exists(), item.descendants().where(linkId = 'in8.1.1').answer.valueString, ' ')
iif(item.descendants().where(linkId = 'in8.1.10').answer.valueString.exists(), item.descendants().where(linkId = 'in8.1.10').answer.valueString, ' ')
iif(item.descendants().where(linkId = 'in8.3.1').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.1').answer.valueString, ' ')
iif(item.descendants().where(linkId = 'in8.3.2').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.2').answer.valueString, ' ')
iif(item.descendants().where(linkId = 'in8.3.3').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.3').answer.valueString, ' ')
iif(item.descendants().where(linkId = 'in8.3.4').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.4').answer.valueString, ' ')
iif(item.descendants().where(linkId = 'in8.3.7.2').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.7.2').answer.valueString, ' ')
iif(item.descendants().where(linkId = 'in8.3.7.3').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.7.3').answer.valueString, ' ')
full name, suffix and degrees for this relying site PI
%sitePIFirstNameOneRepetition + ' ' + %sitePILastNameOneRepetition + ', ' + iif(%sitePISuffixOneRepetition = ' ', '', %sitePISuffixOneRepetition + ', ') + %sitePIDegreesOneRepetition
%sitePICityOneRepetition + ', ' + %sitePIStateOneRepetition
full name, suffix and degrees for this relying site PI and the relying site PI institution and dept
%sitePIInstitutionNameOneRepetition + ' | ' + %sitePIDeptOneRepetition + ' | ' + %fullNameDSSitePIOneRepetition + ' | ' + %sitePILocationOneRepetition
Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator
Is this relying site at the same institution as where the lead principal investigator is conducting the study?
This question is optional. It can be used to pre-populate the lead principal investigator institution details if this relying site is at the same institution as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.
Is this relying site at the same site as where the lead principal investigator is conducting the study?
This question is optional. It can be used to pre-populate the lead principal investigator site details if this relying site is at the same site as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.
Is the relying site PI for this site the same PI as the lead principal investigator conducting the study?
This question is optional. It can be used to pre-populate the lead principal investigator details if this relying site PI is the same PI as the lead principal investigator conducting the study. If you do not want pre-population to occur, you may leave this question blank.
Is this relying site also considered to be the lead site for the study?
Indicator that the lead PI site where the study is being conducted is also participating as this relying site
iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.1').answer.value)
Name of Institution for which their IRB agrees to rely on the decisions of the reviewing IRB at their own institutions.
iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.10').answer.value)
The department name or division for the relying site
iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.3').answer.value)
10-digit phone number, including area code, for the relying institution
iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.4').answer.valueCoding)
iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.5').answer.value)
Institution whose IRB agrees to rely on oversite by the sIRB (Reviewing IRB)
iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.1').answer.value)
Relying Site Principal Investigator First Name
First Name or Given Name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution
iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.2').answer.value)
Relying Site Principal Investigator Last Name
Last name, surname or family name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution
iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.3').answer.value)
Relying Site Principal Investigator Suffix
iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.4').answer.value)
Academic and Professional Degrees associated with the Relying Site Principal Investigator
Academic and Professional degrees associated with the relying site principal investigator
iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.10').answer.value)
The department name or division for the relying site PI
iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.5').answer.value)
10-digit phone number, including area code, for the relying site principal investigator
iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.6').answer.value)
Email address associated with the relying site principal investigator
Address of Relying Site Principal Investigator
iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.1').answer.value)
iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.2').answer.value)
iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.3').answer.value)
iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.4').answer.value)
Principal Investigator responsible for the conduct of the study at a specific relying site research location.
Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)
Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)
The research site(s) where the Lead Principal Investigator is conducting research should also be entered as relying site(s) here, even if at the same institution as entered above for the Lead Principal Investigator. If the Lead Principal Investigator is only managing a coordinating center or other administrative office for the study, do not enter the site again here.
Does this study require a FDA exemption?
Indicator for use of FDA regulated product
Is an IND or IDE being used in this study?
Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?
Select IND for Investigational New Drug or IDE for Investigational Device Exemption
Administrative Use Only (will be hidden in the future)
Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
ID of the Research Study FHIR Resource associated with the study Questionnaire Responses
Questionnaire Response ID of the local considerations Questionnaire Response, if any