Title: Intervention in Protocol Deviation/Non-compliance/Violation
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1 Page No. 1 of 5 Title: Intervention in Protocol Deviation/ SOP Code : SOP/11/V1.0
2 Page No. 2 of 5 Table of Contents No. Contents Page No. 1. Purpose 3 2. Scope 3 3. Responsibility 3 4. Flow Chart 3 5. Detailed instructions Whenever protocol deviation / non-compliance / violation 3 has been observed: 5.2 The IEC Decision Notify the investigator Keep records and follow up 4 6. Glossary 4 7. References 4 8. ANNEX 4 ANNEX 1 Deviation / Non-Compliance / Violation Record 5
3 Page No. 3 of 5 1. Purpose To provide instructions for taking action and maintaining records that identify investigators/institutes who fail to follow the procedures written in the approved protocol or to comply with national / international guidelines for the conduct of human research, including those who fail to respond to the IEC requests. 2. Scope This SOP applies to all IEC approved research protocols involving human participants. 3. Responsibility The designated member of the Secretariat is responsible for collecting and recording the noncompliance list (AF/EC/01/11/V1.0). 4. Flow chart No. Activity 1 Noting protocol deviation / noncompliance / violation Responsibility IEC members and Chairperson 2 Ethics Committee s discussion and decision IEC members and Chairperson 3 Notify the investigator IEC Secretariat, members and Chairperson 4 Keep records and follow up IEC Secretariat 5. Detailed instructions 5.1 Whenever protocol deviation / non-compliance / violation has been observed: Ensure that the project in which non-compliance has been observed is included in the agenda of the IEC meeting. Maintain a file that identifies projects that are found to be non-compliant with national/international regulations or investigators who fail to follow protocol approval stipulations or fail to respond to the IEC request for information/action. Note: The Ethics Committee shall withhold at their discretion the approval of current studies or refuse subsequent applications from the investigators cited. Such decisions are recorded in the minutes.
4 Page No. 4 of The IEC Decision The Chairperson notifies the investigator regarding the IEC s action in writing, when the full board Ethics Committee withholds at their discretion the approval of current studies or refuse subsequent applications from the investigators cited or refuses subsequent applications from an investigator cited for noncompliance. 5.3 Notify the investigator The IEC Secretariat members record the IEC s decision. Draft and type a notification letter. Request the Chairperson to sign and date the letter. Make four copies of the notification letter. Send the original copy of the notification to the investigator. 5.4 Keep records and follow up Keep a copy of the notification letter in the non-compliance file. Store the file in the shelf with an appropriate label. Follow up the action after a time period as suggested by the Ethic Committee. 6. Glossary Deviation / Non - compliance / Violation : The IEC monitors whether investigators do not perform the study in compliance with the approved protocol, ICH GCP, FDA regulations and/or fail to respond to the IECs request for information/action. 7. References 7.1 World Health Organization, Operational Guidelines for Ethics Committees that Review Biomedical Research, International Conference on Harmonization, Guidance on Good Clinical Practice (ICHGCP) Forum for Ethical Review Committees in Asia and the Western Pacific SOPs ANNEX ANNEX 1 AF/EC/01/11/V1.0 Deviation/Non-Compliance/Violation Record
5 Page No. 5 of 5 ANNEX 1 AF/EC/01/11/V1.0 Deviation / Non-Compliance / Violation Record Application Number: / - Date: Study Title: Investigator Institution: Sponsor: Deviation from protocol Non-Compliance Major Minor Violation Description: IEC Decision: Actions taken: Outcome: Reported by:. Date:.
Title: Audit and Inspection of the IEC. SOP Code: SOP/24/V1.0. Effective date: 03/05/2013
Page 1 of 6 Title: Effective date: 03/05/2013 1 Page 2 of 6 Table of Contents No. Content Page No. 1 Purpose 3 2 Scope 3 3 Responsibility 3 4 Flow chart 3 5 Detailed instructions 3 5.1 Call for an Audit
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