NATIONAL COMMITTEE ON RESEARCH IN THE SOCIAL SCIENCES AND HUMANITIES (NCRSH)

 SOP NO.9: Standard Operating Procedure for Annual Continuing Review

Purpose

This SOP describes how annual continuing reviews of protocols are managed by NCRSH.

 Scope

The SOP applies to the conducting of continuing review of approved study protocols at intervals appropriate to the degree of risk but not less than once per annual period if the study is to implemented for a period over twelve months. The purpose of the annual continuing review is to review the progress of the entire study and not just changes in it in order to ensure the continued protection of the safety, rights and well-being of the research participants. Continuing review of a study may not be conducted through an expedited review procedure, unless

• The study was eligible for, and initially reviewed through an expedited review procedure; or
• The study has changed such that the only activities remaining are eligible for expedited review

The usage of this SOP applies to NCRSH members, secretariat and investigators

 Allowable Exceptions

This SOP is meant to be followed without deviation

 Specific Procedure

• NCRSH approval is valid for a maximum period of twelve months. Therefore, all approved protocols shall apply for continual review every twelve months (for studies taking longer than twelve months to be finalised)

• Investigators submit an application for continuing review using a NCRSH Continuing Review Form.  The application for continuing review shall be accompanied by a progress report.

• In the case of students, proof of continued affiliation to the study programme must accompany the application package
• Upon receipt of the application package, secretariat performs an administrative screening to check for completeness of the package
• Basing on the determination by secretariat, review shall be done either through full committee review (SOP No3) or through expedited review procedure (SOP No.4).

• Feedback to investigator shall be in accordance with the standard operating procedure determined for the annual continuing review of that protocol and as guided under the scope section of this SOP.