C.1.1 Many records are generated before and during the conduct of a clinical trial. The nature and extent of those records generated and maintained are dependent on the trial design, its conduct, application of risk proportionate approaches and the importance and relevance of that record to the trial
C.1.2 Determining which records are essential will be based on consideration of the guidance in this appendix.
C.1.3 The essential records permit and contribute to the evaluation of the conduct of a trial in relation to the compliance of the investigator and sponsor with Good Clinical Practice (GCP) and applicable regulatory requirements and the reliability of the results produced. The essential records are used as part of the investigator oversight and sponsor oversight (including monitoring) of the trial. These records are used by the sponsor’s independent audit function and during inspections by regulatory authority(ies) to assess the trial conduct and the reliability of the trial results. Certain essential records may also be reviewed by the institutional review board/independent ethics committee (IRB/IEC) in accordance with applicable regulatory requirements. The investigator/institution should have access to and the ability to maintain the essential records generated by the investigator/institution before and during the conduct of the trial and retain them in accordance with applicable regulatory requirements