C.2.1 Records should be identifiable and version controlled (when appropriate) and should include authors, reviewers and approvers as appropriate, along with date and signature (electronic or physical), where necessary.
C.2.2 For activities that are transferred or delegated to service providers by the sponsor or investigator/institution, respectively, arrangements should be made for the access and management of the essential records throughout the trial and for their retention following completion of the trial.
C.2.3 These essential records should be maintained in or referred to from repositories held by the sponsor and by the investigator/institution for their respective records. These repositories may be referred to as a trial master file (TMF). The repository held by the investigator/institution may also be referred to as the investigator site file (ISF).
C.2.4 The sponsor and investigator/institution should maintain a record of where essential records are located, including source records. The storage system(s) used during the trial and for archiving (irrespective of the type of media used) should provide for appropriate identification, version history, search and retrieval of trial records.
C.2.5 The sponsor and investigator/institution should ensure that the essential records are collected and filed in a timely manner, which can greatly assist in the successful management of a trial. Some essential records should generally be in place prior to the start of the trial and may be subsequently updated during the trial.
C.2.6 The sponsor and investigator/institution should retain the essential records in a way that ensures that they remain complete, readable and readily available and are directly accessible upon request by regulatory authorities, monitors and auditors. Alteration to the essential records should be traceable.
C.2.7 The sponsor and investigator/institution should ensure the retention of the essential records required to fulfil their responsibility. The original records should generally be retained by the responsible party who generated them.
C.2.8 In order to fulfil their responsibilities in the conduct of the trial, the sponsor and investigator/institution may need access to or copies of one another’s relevant essential records before and during the conduct of the trial. At the end of the trial, each party should retain their essential records (see sections 2.12.11 and 3.16.3(a)). The record location may vary during the trial depending on the nature of the record. For example, the investigator may access relevant essential records from the sponsor (e.g., suspected unexpected serious adverse reactions (SUSAR) reports) via a sponsor-provided portal, and these essential records would need to be retained by the investigator/institution at the end of the trial.
C.2.9 When a copy is used to permanently replace the original essential record, the copy should fulfil the requirements for certified copies.
C.2.10 Some records are typically maintained and retained only by the sponsor (e.g., those related solely to sponsor activities such as data analysis) or only by the investigator/institution (e.g., those that contain confidential participant information). Some records may be retained by the sponsor and/or the investigator/institution.
C.2.11 Careful consideration should be given to the sharing of records when there are blinding considerations and when the records are subject to applicable data protection legislation. For the sharing of essential records with service providers, see section C.2.2.
C.2.12 Certain essential records may not be specific to a trial but may be related to the investigational product, facilities or processes and systems, including computerised systems, involved in running multiple trials and retained outside the trial-specific repositories (e.g., Investigator’s Brochure, master services agreements, standard operating procedures, validation records).