Review of study completion reports

13.1 Purpose

The purpose of this SOP is to provide instructions on how to review the study completion report for every study, previously approved by the IRB.

13.2 Scope

This SOP applies to the review of the study completion written report which is a mandatory review of each PI/ Investigator’s activities presented to the IRB as a written report at the completion of the study.

13.3 Responsibility

It is the responsibility of the IRB to review the study completion report and notify it or request further information/ clarification, if necessary.

13.4 Detailed instructions

13.4.1 Before each IRB meeting

  • The secretariat will receive study completion reports from the PIs as per the strength of an IRB sitting.
  • The Secretariat reviews the report for completeness, before tabling it for an IRB meeting.
  • The IRB Secretariat should keep the study completion reports on the agenda for  that particular IRB meeting

13.4.2 Before and during the IRB meeting

  • IRB member(s) should review the full copy of the final report.
  • The members will discuss pertinent points emerging from the report in the IRB meeting.
  • Wherever appropriate, the chairperson may call for consensus to accept it or request further information/clarification or take any other action as suggested by IRB.

13.4.3 After the IRB meeting

  • The secretariat will note the decision in the meeting minutes and the study will be considered as closed if the final report document is accepted as it is.
  • The IRB’s decision is communicated to the PI/investigator. In case further information/action is requested, the same should be followed by the PI and communicated to the IRB office within 30 days.
  • Upon receipt of a satisfactorily completed final report, the secretariat will accept and file the final report in the project master file.
  • The IRB secretariat will archive the entire study protocol and the report for a period of 5 years from the date of the acceptance of the final report.