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Documentation of the IRB activities

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

  1. IRB members’ records
  2. Appointment letters of each IRB member
  3. Acceptance letters of each IRB member
  4. Signed and dated recent Curriculum Vitae of each IRB member
  5. Confidentiality agreement letters of each IRB member
  6. Training records for each IRB member
  7. Documentation of resignation / termination of membership
  8. IRB membership roster
  9. IRB attendance register
  10. IRB meeting agenda and minutes
  11. Standard operating procedures
  12. Annual reports

12.5.Β  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.

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