Essential records

What are essential records

Many records are generated before and during the conduct of a clinical trial.

The nature and extent of records generated and maintained before and during the conduct of a clinical trial are dependent on:

• the trial design;

• its conduct;

• application of risk proportionate approaches; and

• the importance and relevance of that record to the trial.

Essential records are the documents and data (and relevant metadata), in any format, associated with a clinical trial that facilitate the ongoing management of the trial and collectively allow the evaluation of the methods used, the factors affecting a trial and the actions taken during the trial conduct to determine the reliability of the trial results produced and the verification that the trial was conducted in accordance with GCP and applicable regulatory requirements.

Assessing the essentiality of trial records

Please refer to Section C.3.1 of ICH E6 (R3) GCP Guideline to assess the essentiality of trial records.

Management of essential records

Essential records should (be):

• identifiable

• version controlled (when appropriate)

• include authors, reviewers and approvers as appropriate, along with date and signature (electronic or physical), where necessary

• maintained in repositories (e.g., Investigator Site File maintained by the Principal Investigator (PI), Trial Master File maintained by the sponsor)

• defined in a record of where essential records (including source records) are located

• maintained in a storage system during the trial and archival period, that provides appropriate identification, version history, search and retrieval of essential records

• collected and filed in a timely manner

• retained 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

• demonstrate that alterations are traceable

• certified as true copies when copies are made

Please note that the original essential records should generally be retained by the responsible party who generated them.

• In order to fulfil their responsibilities in the conduct of the trial, the sponsor and PI 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 respective essential records.

• In situations where the PI has to retain essential records that were maintained by the sponsor (e.g., Unexpected Serious Adverse Drug Reaction / USADR reports maintained via a sponsor's portal), these essential records should still be retained by the PI at the end of the trial.

Access to essential records

Essential records are reviewed during monitoring and audits by the sponsor, reviews by the IRB, and GCP inspections by Regulatory Authorities. Thus, direct access to essential records should be provided to Monitors, Auditors, IRB staff and Regulatory Authorities.

Retention of essential records

Essential records should be retained until the later or latest, as the case may be, of the following:

• the date where there is no more pending or contemplated application for product registration;

• the expiry of 2 years after the last of such registrations is granted;

• where the clinical trial is terminated, the expiry of 2 years after HSA has been informed of the termination of the trial;

• the expiry of 6 years after the conclusion of the clinical trial;

• where the record is of a clinical trial that involves an applicable Cell, Tissue or Gene Therapy product and relates to the traceability of that product — the expiry of 30 years after the expiry date of that product or any other shorter period that HSA allows in a particular case; or

• the expiry of such other period as HSA may direct in any particular case.

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