Detailed List
Recommended for all IRB-approved research studies:
- Protocol - copy of the IRB-approved protocol. If the protocol has been modified during the course of the study, a copy of each IRB-approved modification of the protocol should be kept on file.
- Protocol Adherence Documentation (required) - subject records (research-related, such as case reports, medical records, etc.) that demonstrate adherence to the IRB-approved protocol.
- List of Study Participants (required) - data for each participant should include:
- Participant number
- Date consented
- Date intervention/participation began
- Signed Informed Consent Forms (required) - copies of the IRB-approved Informed Consent Document signed by each participant.
- Informed Consent Document - a copy of the stamped, IRB-approved Consent Form. If the Consent Form has been modified during the study, a copy of each IRB-approved modification of the Consent Form should be kept on file.
- IRB Correspondence - all correspondence between the Principal Investigator and the IRB, including letters of initial approval, modification, and renewal.
- Adverse Events Reports - copies of all correspondence related to the reporting of serious and unexpected adverse events to the IRB and, where applicable, the study sponsor and/or FDA.
- Research Team List (required) - a list of all members of the research team with a description of each member's responsibility; which member has authority to enter, delete or change data; and each member's printed name and signature.
- Education Certificates (required) - copies of certificates for IRB-required education in human subject protections for all investigators and personnel directly involved in the study.
- Final Report - when study has been closed, keep a copy on file with study records.
Investigators with Sponsored Studies should also keep on file:
- Sponsor Correspondence - all correspondence between the sponsor and Principal Investigator pertaining to the conduct of the study.
- Sponsor Monitoring Log/Reports - a record of the study sponsor monitor's site visits including monitoring correspondence.
Investigators with studies under FDA oversight (IND and IDE) are required to keep on file:
- FDA Correspondence - all correspondence between the FDA and Principal Investigator pertaining to the conduct of the study.
- Participant Screening Log - a list of all subjects who were consented and were screened to be a participant in the study, with documentation of subject eligibility/ineligibility. If determined ineligible, the reason for the subject's ineligibility should be documented.
- Laboratory Certification - current laboratory certification for all labs involved with the study.
- Range of Normal Values (if blood work is required) - the range of normal values recognized by the laboratory performing the analyses.
Investigational New Drug (IND) Applications Only:
- Investigator's Brochure
- Form FDA-1571
- Form FDA-1572
|
