RECORDS MAINTAINED BY ETHICS COMMITTEE

MODULE 6

All documentation and communication of an ethics committee are to be dated, filed and preserved according to the standard operative procedures. Strict confidentiality is to be maintained during access and retrieval procedures. Records should be maintained for the following:-

  • The constitution and composition of the ethics committee;
  • The curriculum vitae of all the committee members;
  • Standard operating procedure followed by the committee;
  • National and international guidelines;
  • Copies of the protocol data collection formats, case report forms, investigational brochures etc. submitted for review;
  • All correspondence with committee members and investigators regarding application decision and follow up;
  • Agenda of all ethics committee meetings;
  • Minutes of all ethics committee meetings with signature of the chair person
  • Copies of decision communicated to the applicants;
  • Records of all notification issued for premature termination of a study with a summary of the reasons;
  • Final reports of the study including microfilms, compact disks and / or video – recordings.
  • All records must be safely maintained and after the completion/ termination of the study for not less than five years from the date of completion or termination of the trial.

The ethics committee shall open for inspections by the officers of central drugs standard control organization to verify compliance to the requirements of schedule Y, Good Clinical Practices guidelines and other applicable regulations.
Records Keeping: The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 5 years after completion of the trial and make them available upon request from the regulatory authorities.