All documentation and communication of an Ethics Committee are to be dated, filed and preserved according to the standard operating procedures. It is the responsibility of IEC staff to ensure that all study files are prepared, maintained, and kept securely for a period of not less than five years (both in soft and hard copy) form the date of study completion or termination. Approved protocols are assigned unique identifier that ensures confidentiality and facilitates retrieval at any time. Strict confidentiality must be maintained during access and retrieval procedures. Records should be maintained for the following namely:

• The constitution and composition of the IEC.
• The curriculum vitae of all IEC members.
• Standard operating procedures followed by the IEC.
• National and international guidelines.
• Copies of the protocol, data collection formats, CRFs, investigational brochures etc. submitted for review.
• All correspondence with IEC members and investigators regarding application, decision and follow up.
• Agenda of all IEC meetings.
• Minutes of all IEC meetings with signature of the Chairperson/Member Secretary.
• Copies of decisions communicated to the applicants.
• Record of all notification issued for premature termination of a study with a summary of the reasons.
• Final report of the study including microfilms, CDs and Video-recordings. All closed study files will be separately archived. After completion of archival period the closed files will be shredded and disposed of. A log book of disposed documents will be maintained.