The purpose of this SOP is to detail how the IRB manages any premature termination/ suspension/ discontinuation of a research study. Protocols are usually terminated at the recommendation of the IRB, PI, sponsor or other authorized bodies wherein subject enrolment and study follow-up are discontinued before the scheduled end of the study.
The SOP relates to any research or study that is recommended for suspension /recommendation/ discontinuation before its scheduled time of completion.
It is the duty of the chairperson, on recommendation of the IRB committee to terminate or suspend any previously approved study when the safety or benefit of the study participant is doubtful or at undue risk.
The IRB secretary is then given the responsibility of managing the premature termination/ suspension / discontinuation process.
14.4 Detailed Instructions:
14.4.1. Recommendation for study termination / suspension / Discontinuation.
- The IRB secretariat will be notified about any recommendation from PI, sponsors or other authorized bodies for the premature termination of research or study protocol.
- The IRB members reserves the right to prematurely terminate the research or study if the study protocol is non- complainant or violation is detected.
- SAE occurring at trial may require the study to be prematurely terminated in order to safeguard the study participants.
- The IRB secretariat will notify the PI to prepare and submit a premature termination report.
- The IRB secretariat will receive the premature termination report submitted by the PI and verify the contents of the report for completion.
- The report should include the following components:
- A brief report of the protocol with the relevant results and accrual data, which must be signed by the PI and dated.
- Date of IRB approval.
- Date of start of the Study.
- Date of Termination/Suspension.
- Brief report of the reason for termination/ suspension.
- Any action taken post suspension.
- Details of the study participant including the total no of participants, no of drop outs, no of participants lost to follow up including reasons for the same.
- Any SAE recorded during the study.
- The secretary will be responsible for checking the completeness
14.4.2 . Review and discuss the termination / suspension / discontinuation package
- IRB will review the termination report at regular full IRB meeting to discuss about the
- The member secretary in the meeting will inform the premature termination of the project and the IRB members will review the premature termination report
- If the premature termination report is unclear/more information is required from the PI, the secretariat is instructed to send a query to the
14.4.3 Notice to the PI:
- The secretary will issue a notification letter acknowledging the approval of termination or query letter to request information regarding the premature termination.
- The secretary will pass the notification letter to the PI for their records within14 days after the meeting.
14.4.4 Store the protocol documents
- The secretary will preserve the original copy of the premature termination report in the Protocol file and send the file to
- The protocol documents will be stored for a period of 5 years from the date of project
- If a query is sent to PI, on receipt of the reply letter, it is reviewed in the forthcoming full IRB meeting.