Reporting of Protocol Deviation

Reporting of Protocol Deviation / Non-Compliance/ Violation / Waiver

9.1 Purpose

This section provides the managements which includes taking action and maintaining records, when investigators/ trial sites, fail to –

  • Follow the procedures written in the approved protocol
  • Comply with national / international guidelines for the conduct of biomedical research, including those who fail to respond to the IRB requests.

9.2 Scope

This SOP applies to all IRB approved biomedical research protocols.

9.3 Responsibility

IRB secretariat is responsible for receiving deviations /violations/waiver reports submitted by the PI and placing it on agenda of the meeting.

IRB members should review and take action on such reports.

9.4 Detailed instruction

9.4.1 Detection of Protocol deviation/ non-compliance/ violation/waiver

9.4.1.a The IRB members monitoring the project at the trial site can

detect protocol deviation/non-compliance / violation, if the project is –

  • not conducted as per approved protocol / national / international regulations
  • when scrutinizing annual / periodic reports / SAE reports
  • any other communication received from the Investigator / trial site / sponsor /study monitor / CRO

9.4.3 IRB discussion, decision and action

  • If the protocol deviation / non-compliance / violation is detected by IRB member during monitoring visit   he/she   will   present   the   protocol   deviation   / noncompliance / violation information.
  • If detected by secretariat / forwarded by PI, the member secretary will present the protocol deviation / non-compliance / violation / waiver information.
  • The chairperson / IRB members will review the information available and take a decision depending on the seriousness of the violation.
  • The decision will be taken to ensure that the safety and rights of the research participants are safeguarded. The decision will be taken by consensus and if no consensus is arrived at, voting will be conducted

The actions taken by IRB could include one or more of the following:

  • Inform the PI that IRB has noted the violation / noncompliance / deviation and inform the PI to ensure that deviations / noncompliance / violations do not occur in future and follow IRB recommendations.
  • Enlist measures that the PI would undertake to ensure that deviations /noncompliance /violations do not occur in future.
  • Reprimand the PI
  • Call for additional information
  • Suspend the study till additional information is made available and is scrutinized.
  • Suspend the study till recommendations made by the IRB are implemented by the PI and found to be satisfactory by the IRB.
  • Suspend the study for a fixed duration of time.
  • Inform the Director, CIHSR
  • Revoke approval of the current study.
  • Inform DCGI / Other relevant regulatory authorities
  • Keep other research proposals from the PI/ Co-PI under abeyance
  • Review and / or inspect other studies undertaken by PI/Co-PI

9.4.4 Notify the investigator

  • The IRB secretariat records the IRB decision, drafts and types a notification letter.
  • The chairperson / member secretary signs and dates the letter.
  • The IRB secretariat makes four copies of the notification letter.
  • The IRB secretariat sends the original copy of the notification to the investigator
  • The IRB secretariat sends a copy of the notification to the relevant national authorities and other trial sites, in case of multi-centric trial.
  • The IRB secretariat sends the fourth copy to the sponsor or the CRO of the study.

9.4.5 Records and follow up to be kept by IRB secretariat

  • Keeps the last copy of the notification letter in the “non-compliance’ file.
  • Stores the file on the shelf with an appropriate label.
  • Follows up the action after a reasonable time.
  • Maintains a file that identifies investigators who are found to be non-compliant with national/international regulations or who fail to follow protocol approval stipulations or fail to respond to the IRB request for information/action