12.1 Purpose
To outline the procedures for documenting the IRB activities.
12.2 Scope
This SOP will apply to all biomedical and health research activities done through IRB CIHSR, without regard to the source of funding.
12.3 Responsibility
It is the responsibility of IRB Secretary to maintain IRB files at IRB office.
12.4 Detailed instructions
12.4.1 IRB records will include the following
- IRB members’ records
- Appointment letters of each IRB member
- Acceptance letters of each IRB member
- Signed and dated recent Curriculum Vitae of each IRB member
- Confidentiality agreement letters of each IRB member
- Training records for each IRB member
- Documentation of resignation/termination of membership
- IRB membership roster
- IRB attendance register
- IRB meeting agenda and minutes
- Standard operating procedures
- Annual reports
12.5. RECORD KEEPING AND ARCHIVING
12.5.1 All documentation and communication of the IRB will be dated, filed and preserved in the designated computer kept in the IRB office.
12.5.2 Confidentiality will be maintained during access and retrieval procedures and will be done through the IRB secretary.
12.5.3 All active and inactive (closed) files will be appropriately labelled and archived separately in designated
12.5.4 Records will be maintained in hard copies as well as soft
12.5..5 All records will be archived for a period of at least 5 years after the completion/ termination of the
12.5.6 Documents related to regulatory clinical trials must be archived for 5 years after the completion/termination of the study or as per
12.5.7 Records may be archived for a longer period, if required by the sponsors/regulatory bodies.
12.5.8 IRB will also maintain electronic storage of records for all studies conducted.
12.6 Documents to be maintained by IRB for record
Table 3 showing the various categories of documents and the specifics
Documentation of the IRB activities
| Type of document | Document specifics |
| Administrative documents | Constitution and Composition of the IRB Appointment letters Signed and dated copies of the most recent curriculum vitae of all IRB members Signed confidentiality agreements COI declarations of members Training records of IRB members Financial records of IRB Registration/accreditation documents, as required A copy of national and international guidelines and applicable regulations Regulatory notifications Meeting-related documents Agenda and minutes All communications received or made by the IRB SOPs |
| Proposal-related documents | One hard copy and a soft copy of the initial research proposal and all related documents Decision letters Any amendments submitted for review and approval Regulatory approvals SAE, AE reports Protocol deviations/violations Progress reports, continuing review activities, site monitoring reports All correspondence between the EC and researchers Record of notification issued for premature termination of a study with a summary of the reasons Final report of the study Publications, if any |
12.7 Access to the IRB records
IRB records will be made available for inspection and copying by authorized representatives of regulatory bodies after receiving a formal request in writing.