LinkId Text Definition Answer continuing-review-populate-exampleQR QuestionnaireResponse cr1 Research Study cr1.1 Study Title Study of Drug A for arthritis cr1.2 IRB Protocol Number PRO098765 cr1.3 Enrollment Status Temporary Codes open: Open for enrollment cr1.4 Intervention Status Temporary Codes continue-meds: Continuing interventions cr1.5 Study Status ResearchStudyStatus active: Active cr1.6 Funding Source(check all that are applicable) Temporary Codes federal: Federal cr12 sIRB (Reviewing Institution) cr12.1 sIRB (Reviewing Institution) Name X Pharmaceutical Research IRB cr9 Submission Type cr9.1 Is this Continuing Review Form being submitted by the lead PI site on behalf of all of the relying sites? expandedYes-NoIndicator Y: Yes ExternalDataFor_cr9.2 External Data For linkId cr9.2 cr11 Site Principal Investigator Institution cr11.1 Site Principal Investigator Institution Name Sample University Medical Center cr2 Site Principal Investigator cr2.1 First Name Jane cr2.4 Last Name Doe cr2.6 Degree(s) MD cr2.10 Site Principal Investigator Department Name or Division Orthopedics cr2.2 Phone 567-123-1234 cr2.3 Email drjanedoe@sampleuniversity.edu cr3 Accrual of Participants cr3.1 Provide counts for the following cr3.1.1 Participants enrolled since activation cr3.1.1.1 Previous Accrual 10 cr3.1.1.2 Additional enrollees this approval period 20 cr3.1.1.3 Total 30 cr3.1.2 Participants enrolled since last approval cr3.1.2.1 Previous Accrual 10 cr3.1.2.2 Additional enrollees this approval period 10 cr3.1.2.3 Total 20 cr3.1.3 Participants approved to enroll cr3.1.3.1 Previous Accrual 10 cr3.1.3.2 Additional enrollees this approval period 10 cr3.1.3.3 Total 20 cr3.1.4 Participants consented cr3.1.4.1 Previous Accrual 10 cr3.1.4.2 Additional enrollees this approval period 10 cr3.1.4.3 Total 20 cr3.1.5 Participants withdrawn cr3.1.5.1 Previous Accrual 0 cr3.1.5.2 Additional enrollees this approval period 0 cr3.1.5.3 Total 0 cr3.1.6 Participants lost to contact cr3.1.6.1 Previous Accrual 0 cr3.1.6.2 Additional enrollees this approval period 0 cr3.1.6.3 Total 0 cr3.1.7 Participants with screen failures cr3.1.7.1 Previous Accrual 0 cr3.1.7.2 Additional enrollees this approval period 0 cr3.1.7.3 Total 0 cr3.1.8 Participants still active or follow-up cr3.1.8.1 Previous Accrual 10 cr3.1.8.2 Additional enrollees this approval period 10 cr3.1.8.3 Total 20 cr3.1.9 Participants completed study cr3.1.9.1 Previous Accrual 5 cr3.1.9.2 Additional enrollees this approval period 0 cr3.1.9.3 Total 5 cr3.1.10 By Sex cr3.1.10.1 Men cr3.1.10.1.1 Previous Accrual 6 cr3.1.10.1.2 Additional enrollees this approval period 5 cr3.1.10.1.3 Total 11 cr3.1.10.2 Women cr3.1.10.2.1 Previous Accrual 4 cr3.1.10.2.2 Additional enrollees this approval period 15 cr3.1.10.2.3 Total 19 cr3.1.11 By Race cr3.1.11.1 White cr3.1.11.1.1 Previous Accrual 3 cr3.1.11.1.2 Additional enrollees this approval period 3 cr3.1.11.1.3 Total 6 cr3.1.11.2 Black or African American cr3.1.11.2.1 Previous Accrual 3 cr3.1.11.2.2 Additional enrollees this approval period 4 cr3.1.11.2.3 Total 7 cr3.1.11.3 Asian cr3.1.11.3.1 Previous Accrual 2 cr3.1.11.3.2 Additional enrollees this approval period 3 cr3.1.11.3.3 Total 5 cr3.1.11.4 American Indian or Alaska Native cr3.1.11.4.1 Previous Accrual 1 cr3.1.11.4.2 Additional enrollees this approval period 0 cr3.1.11.4.3 Total 1 cr3.1.11.5 Native Hawaiian or other Pacific Islander cr3.1.11.5.1 Previous Accrual 0 cr3.1.11.5.2 Additional enrollees this approval period 1 cr3.1.11.5.3 Total 1 cr3.1.11.6 More than One Race cr3.1.11.6.1 Previous Accrual 2 cr3.1.11.6.2 Additional enrollees this approval period 0 cr3.1.11.6.3 Total 2 cr3.1.11.7 Unknown/Not Reported cr3.1.11.7.1 Previous Accrual 0 cr3.1.11.7.2 Additional enrollees this approval period 0 cr3.1.11.7.3 Total 0 cr3.1.12 By Ethnicity cr3.1.12.1 Hispanic or Latino cr3.1.12.1.1 Previous Accrual 4 cr3.1.12.1.2 Additional enrollees this approval period 5 cr3.1.12.1.3 Total 9 cr3.1.12.2 Not Hispanic or Latino cr3.1.12.2.1 Previous Accrual 4 cr3.1.12.2.2 Additional enrollees this approval period 5 cr3.1.12.2.3 Total 9 cr3.1.12.3 Unknown/Not Reported cr3.1.12.3.1 Previous Accrual 0 cr3.1.12.3.2 Additional enrollees this approval period 0 cr3.1.12.3.3 Total 0 cr3.2 Vulnerable Populations cr3.2.1 Number of potentially vulnerable participants enrolled cr3.2.1.1 Previous Accrual 0 cr3.2.1.2 Additional enrollees this approval period 0 cr3.2.1.3 Total 0 cr3.2.2 Check the applicable checkboxes if these groups are represented in the columns above cr3.2.2.3 Employees Temporary Codes AdditionalEnrollees: Additional enrollees this approval period cr3.2.2.8 Students Temporary Codes PreviousAccrual: Previous Accrual cr4 Study Report cr4.5 Since your last report: cr4.5.1 Summarize the study progress [answer] cr4.5.2 Have participants experienced any benefits? expandedYes-NoIndicator Y: Yes cr4.5.3 If yes, please summarize the benefits: [answer] cr4.5.4 Have participants been withdrawn from this study? expandedYes-NoIndicator Y: Yes cr4.5.5 If yes, please summarize the withdrawals: [answer] cr4.5.6 Have any participants or others complained about the research? expandedYes-NoIndicator Y: Yes cr4.5.7 If yes, please summarize the complaints: [answer] cr4.5.8 Has any new and relevant literature been published related to the risks or benefits associated with this research? expandedYes-NoIndicator Y: Yes cr4.5.9 If yes, please summarize relevance to study: [answer] cr4.5.10 Have there been any interim findings? expandedYes-NoIndicator Y: Yes cr4.5.11 If yes, please summarize findings: [answer] cr4.5.12 Have there been any multi-center trial reports? expandedYes-NoIndicator Y: Yes cr4.5.13 If yes, please summarize findings and recommendations [answer] cr4.5.14 Have there been any data safety monitoring board reports? expandedYes-NoIndicator Y: Yes cr4.5.15 If yes, please summarize findings and recommendations: [answer] cr4.5.16 In the opinion of the Principal Investigator, have the risks or potential benefits changed? expandedYes-NoIndicator Y: Yes cr4.5.17 If yes, please summarize the changes: [answer] cr4.5.18 Has an audit of the research been conducted by a federal agency or sponsor? expandedYes-NoIndicator Y: Yes cr4.5.19 Have there been any presentations or publications (including abstracts) from this research? expandedYes-NoIndicator Y: Yes cr4.5.20 Have there been any substantial changes to the study (protocol, consent forms, or other study documents) or to the risk-benefit assessment? expandedYes-NoIndicator Y: Yes cr4.5.21 If yes, please summarize the changes: [answer] cr4.5.22 Was informed consent obtained from all enrolled participants? expandedYes-NoIndicator N: No cr4.5.23 Has there been any other relevant information regarding this protocol? expandedYes-NoIndicator Y: Yes cr4.5.24 If yes, please summarize: [answer] cr5 Adverse Events cr5.1 Have there been any internal or local adverse events in the research? expandedYes-NoIndicator Y: Yes cr5.2 Did these adverse events occur at the frequency and level of severity expected? expandedYes-NoIndicator Y: Yes cr5.3 Have any protocol deviations or violations occurred in this study? expandedYes-NoIndicator Y: Yes cr5.13 If yes, please describe the protocol deviations or violations [answer] cr6 Conflict of Interest cr6.1 Has there been a change in the financial disclosure status of the Principal Investigator or other members of the Research Staff that has not been reported to the IRB? expandedYes-NoIndicator Y: Yes cr6.2 If yes, please explain: [answer] cr17 Attachments cr17.2 Attachment No display for Attachment ADMIN00 Administrative Use Only ADMIN01 Link ID prefix cr 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, if any ResearchStudyExample-sIRB Documentation for this format
Funding Source(check all that are applicable)
Is this Continuing Review Form being submitted by the lead PI site on behalf of all of the relying sites?
Sample University Medical Center | | Jane Doe, MD | Sample City, NC
Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA
Central Campus Test University | | Maria Smith, PhD | Central, MI
Site Principal Investigator Institution Name
Site Principal Investigator Department Name or Division
Additional enrollees this approval period
Participants enrolled since last approval
Native Hawaiian or other Pacific Islander
Number of potentially vulnerable participants enrolled
Check the applicable checkboxes if these groups are represented in the columns above
Have participants experienced any benefits?
Have participants been withdrawn from this study?
If yes, please summarize the withdrawals:
Have any participants or others complained about the research?
If yes, please summarize the complaints:
Has any new and relevant literature been published related to the risks or benefits associated with this research?
If yes, please summarize relevance to study:
Have there been any multi-center trial reports?
If yes, please summarize findings and recommendations
Have there been any data safety monitoring board reports?
If yes, please summarize findings and recommendations:
In the opinion of the Principal Investigator, have the risks or potential benefits changed?
Has an audit of the research been conducted by a federal agency or sponsor?
Have there been any presentations or publications (including abstracts) from this research?
Have there been any substantial changes to the study (protocol, consent forms, or other study documents) or to the risk-benefit assessment?
Was informed consent obtained from all enrolled participants?
Has there been any other relevant information regarding this protocol?
Have there been any internal or local adverse events in the research?
Did these adverse events occur at the frequency and level of severity expected?
Have any protocol deviations or violations occurred in this study?
If yes, please describe the protocol deviations or violations
Has there been a change in the financial disclosure status of the Principal Investigator or other members of the Research Staff that has not been reported to the IRB?
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, if any