LinkId Text Definition Answer initiate-study-populate-exampleQR QuestionnaireResponse in1 Research Study Details in1.1 Study Title A clinical study of the efficacy of Drug A for arthritis in1.2 Study Title (Short) Study of Drug A for arthritis in1.3 IRB Protocol Number PRO098765 in1.4 Study Type Temporary Codes INT: Interventional in5 Other Organization(s) Involved in5.1 Relationship Type Temporary Codes SFS: Sponsor or Funding Source in5.2 Organization Name National Government Funder in5.3 Phone 800-123-1234 in5.4 Sponsor or Funding Source Protocol Number, if applicable Gov-123456 in5.5 Other Organization Name, Relationship Type, Phone and Protocol Number (read-only) National Government Funder | 800-123-1234 | Gov-123456 | Sponsor or Funding Source in5.6 Protocol Number with Organization Name (read-only) Gov-123456 (National Government Funder) in5 Other Organization(s) Involved in5.1 Relationship Type Temporary Codes SFS: Sponsor or Funding Source in5.2 Organization Name Organization of Arthritis Patients Foundation in5.3 Phone 123-123-1234 in5.5 Other Organization Name, Relationship Type, Phone and Protocol Number (read-only) Organization of Arthritis Patients Foundation | 123-123-1234 | | Sponsor or Funding Source in5.6 Protocol Number with Organization Name (read-only) (Organization of Arthritis Patients Foundation) in5 Other Organization(s) Involved in5.1 Relationship Type Temporary Codes CRO: Contract Research Organization (CRO) in5.2 Organization Name Sample CRO, Inc. in5.3 Phone 234-123-1234 in5.5 Other Organization Name, Relationship Type, Phone and Protocol Number (read-only) Sample CRO, Inc. | 234-123-1234 | | Contract Research Organization (CRO) in5.6 Protocol Number with Organization Name (read-only) (Sample CRO, Inc.) in6 sIRB (Reviewing Institution) in6.1 sIRB (Reviewing Institution) Name X Pharmaceutical Research IRB in6.3 Institution Street Address 210 Research Drive in6.4 Institution City Sample City in6.5 Institution State NC in6.6 Institution Zip Code 27612 in6.7 Institution Country United States in6.8 Is a Federal Wide Assurance (FWA) Number assigned? expandedYes-NoIndicator Y: Yes in6.9 Federal Wide Assurance Number (if assigned) 12345 in6.11 Is the sIRB a 3rd party institution? expandedYes-NoIndicator Y: Yes in7 Lead Principal Investigator in7.1 Lead Principal Investigator Institution in7.1.1 Lead Principal Investigator Institution Name Sample University Medical Center in7.1.4 Is a Federal Wide Assurance (FWA) Number assigned? expandedYes-NoIndicator Y: Yes in7.1.5 Federal Wide Assurance Number (if assigned) 56789 in7.3 Lead Principal Investigator in7.3.1 Lead Principal Investigator First Name Jane in7.3.2 Lead Principal Investigator Last Name Doe in7.3.4 Academic and Professional Degrees associated with the Lead Principal Investigator MD in7.3.10 Department Name or Division Orthopedics in7.3.5 Phone 567-123-1234 in7.3.6 Email address drjanedoe@sampleuniversity.edu in7.3.7 Address of Lead Principal Investigator in7.3.7.1 Street Address 105 Sample University Ct. in7.3.7.2 City Sample City in7.3.7.3 State NC in7.3.7.4 Zip Code 27612 in7.3.7.5 Country United States in7.9 Lead Principal Investigator Unique Site (read-only) Sample University Medical Center | | Jane Doe, MD | Sample City, NC in7.10 Lead Principal Investigator Full Name, Suffix and Degrees Jane Doe, MD in8 Relying Site(s) in8.5 Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator in8.5.1 Is this relying site at the same institution as where the lead principal investigator is conducting the study? expandedYes-NoIndicator Y: Yes in8.5.2 Is this relying site at the same site as where the lead principal investigator is conducting the study? expandedYes-NoIndicator Y: Yes in8.5.3 Is the relying site PI for this site the same PI as the lead principal investigator conducting the study? expandedYes-NoIndicator Y: Yes in8.5.4 Is this relying site also considered to be the lead site for the study? expandedYes-NoIndicator Y: Yes in8.1 Relying Site Institution in8.1.1 Relying Institution Name Sample University Medical Center in8.1.4 Is a Federal Wide Assurance (FWA) Number assigned? expandedYes-NoIndicator Y: Yes in8.1.5 Federal Wide Assurance Number (if assigned) 56789 in8.1.6 Reliance Status Temporary Codes APPROVED: Approved for reliance in8.3 Relying Site Principal Investigator in8.3.1 Relying Site Principal Investigator First Name Jane in8.3.2 Relying Site Principal Investigator Last Name Doe in8.3.4 Academic and Professional Degrees associated with the Relying Site Principal Investigator MD in8.3.10 Department Name or Division Orthopedics in8.3.5 Phone 567-123-1234 in8.3.6 Email address drjanedoe@sampleuniversity.edu in8.3.7 Address of Relying Site Principal Investigator in8.3.7.1 Street Address 105 Sample University Ct. in8.3.7.2 City Sample City in8.3.7.3 State NC in8.3.7.4 Zip Code 27612 in8.3.7.5 Country United States in8.9 Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only) Sample University Medical Center | | Jane Doe, MD | Sample City, NC in8.10 Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only) Jane Doe, MD in8 Relying Site(s) in8.5 Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator in8.5.1 Is this relying site at the same institution as where the lead principal investigator is conducting the study? expandedYes-NoIndicator N: No in8.5.3 Is the relying site PI for this site the same PI as the lead principal investigator conducting the study? expandedYes-NoIndicator N: No in8.5.4 Is this relying site also considered to be the lead site for the study? expandedYes-NoIndicator N: No in8.1 Relying Site Institution in8.1.1 Relying Institution Name Test Example University in8.1.3 Relying Institution Phone 6781233456 in8.1.4 Is a Federal Wide Assurance (FWA) Number assigned? expandedYes-NoIndicator Y: Yes in8.1.5 Federal Wide Assurance Number (if assigned) 34567 in8.1.6 Reliance Status Temporary Codes POSSIBLE: Potential/possible in8.3 Relying Site Principal Investigator in8.3.1 Relying Site Principal Investigator First Name Xi-Yang in8.3.2 Relying Site Principal Investigator Last Name Lee in8.3.3 Relying Site Principal Investigator Suffix Jr. in8.3.4 Academic and Professional Degrees associated with the Relying Site Principal Investigator MD, PhD in8.3.5 Phone 6781233456 in8.3.6 Email address XiYangLee@teu.med.edu in8.3.7 Address of Relying Site Principal Investigator in8.3.7.1 Street Address 200 Test Example Circle in8.3.7.2 City Example in8.3.7.3 State MA in8.3.7.4 Zip Code 67890 in8.3.7.5 Country United States in8.9 Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only) Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA in8.10 Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only) Xi-Yang Lee, Jr., MD, PhD in8 Relying Site(s) in8.5 Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator in8.5.1 Is this relying site at the same institution as where the lead principal investigator is conducting the study? expandedYes-NoIndicator N: No in8.5.3 Is the relying site PI for this site the same PI as the lead principal investigator conducting the study? expandedYes-NoIndicator N: No in8.5.4 Is this relying site also considered to be the lead site for the study? expandedYes-NoIndicator N: No in8.1 Relying Site Institution in8.1.1 Relying Institution Name Central Campus Test University in8.1.4 Is a Federal Wide Assurance (FWA) Number assigned? expandedYes-NoIndicator NI: No Information in8.1.6 Reliance Status Temporary Codes POSSIBLE: Potential/possible in8.3 Relying Site Principal Investigator in8.3.1 Relying Site Principal Investigator First Name Maria in8.3.2 Relying Site Principal Investigator Last Name Smith in8.3.4 Academic and Professional Degrees associated with the Relying Site Principal Investigator PhD in8.3.5 Phone 8901231234 in8.3.6 Email address maria.smith@CCTU.med.edu in8.3.7 Address of Relying Site Principal Investigator in8.3.7.1 Street Address 200 Central St. in8.3.7.2 City Central in8.3.7.3 State MI in8.3.7.4 Zip Code 23456 in8.3.7.5 Country United States in8.9 Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only) Central Campus Test University | | Maria Smith, PhD | Central, MI in8.10 Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only) Maria Smith, PhD in9 FDA exemption and IDE/IND Number in9.1 Does this study require a FDA exemption? expandedYes-NoIndicator Y: Yes in9.2 Is an IND or IDE being used in this study? expandedYes-NoIndicator Y: Yes in9.4 Please select IND or IDE: Temporary Codes IND: IND in9.3 IND/IDE Number 432fdw512432fqsdf in10 Questionnaire Version Details in10.1 Questionnaire Version 2 in10.2 Questionnaire Version Date 2021-10-18 ADMIN00 Administrative Use Only (will be hidden in the future) ADMIN01 Link ID prefix in ADMIN02 Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any initiate-study-populate-exampleQR ADMIN03 ID of the Research Study FHIR Resource associated with the study Questionnaire Responses ResearchStudyExample-sIRB Documentation for this format
A clinical study of the efficacy of Drug A for arthritis
Sponsor or Funding Source Protocol Number, if applicable
Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)
National Government Funder | 800-123-1234 | Gov-123456 | Sponsor or Funding Source
Protocol Number with Organization Name (read-only)
Gov-123456 (National Government Funder)
Organization of Arthritis Patients Foundation
Organization of Arthritis Patients Foundation | 123-123-1234 | | Sponsor or Funding Source
(Organization of Arthritis Patients Foundation)
Sample CRO, Inc. | 234-123-1234 | | Contract Research Organization (CRO)
Is a Federal Wide Assurance (FWA) Number assigned?
Federal Wide Assurance Number (if assigned)
Lead Principal Investigator Institution Name
Academic and Professional Degrees associated with the Lead Principal Investigator
Lead Principal Investigator Unique Site (read-only)
Sample University Medical Center | | Jane Doe, MD | Sample City, NC
Lead Principal Investigator Full Name, Suffix and Degrees
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?
Is this relying site at the same site as where the lead principal investigator is conducting the study?
Is the relying site PI for this site the same PI as the lead principal investigator conducting the study?
Is this relying site also considered to be the lead site for the study?
Relying Site Principal Investigator First Name
Relying Site Principal Investigator Last Name
Academic and Professional Degrees associated with the Relying Site Principal Investigator
Address of Relying Site Principal Investigator
Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)
Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)
Relying Site Principal Investigator Suffix
Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA
Central Campus Test University | | Maria Smith, PhD | Central, MI
Does this study require a FDA exemption?
Is an IND or IDE being used in this study?
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