What is new and what stays in?
"...they must stay complete, readable, secure, and protected from unauthorised changes."
What stays the same.
Responsibility for Retention
The sponsor is still legally responsible for making sure essential trial records are kept for the required period. Investigators must also keep their site records, and although tasks can be delegated to vendors, overall responsibility does not transfer.
What Records Must Be Kept
The same types of records must still be retained. This includes the Trial Master File (TMF), Investigator Site File (ISF), essential documents, and participants’ medical records. These records must allow regulators to review and understand the trial.
Inspection and Accessibility
Records must remain organised and accessible for the entire retention period. Regulators can request and inspect them at any time.
Format and Data Integrity
Records can be paper or electronic, but they must stay complete, readable, secure, and protected from unauthorised changes. Electronic systems must continue to maintain audit trails and preserve data integrity.
"These records must allow regulators to review and understand the trial."
"...structured data, metadata, and system audit trails may be considered part of the trial record"
What is new.
Extended Retention Period
The minimum retention period increases from 5 years to 25 years under Regulation 31A. The 25-year period starts the day after the trial officially ends and applies to the TMF, documents that have been in the TMF, and participants’ medical records.
"Retention of the essential records within the TMF (including the investigator site file) and the medical records of trial participants is a legal requirement as described in Regulation 31A.
The sponsor and the investigator, and any delegated service providers, must ensure that the documents contained, or that have been contained, in the TMF, as well as the medical files of trial participants are retained for at least 25 years beginning the day after the conclusion of the trial."
- MHRA
Alignment to ICH E6(R3)
The Medicines and Healthcare products Regulatory Agency has formally aligned the definition of essential records with ICH E6(R3). This reinforces that structured data, metadata, and system audit trails may be considered part of the trial record where they are needed to reconstruct the study.
Clearer Recognition of Metadata and System Records
The update makes it clearer that electronic system data, logs, and related metadata may need to be retained as part of the essential record. This reflects modern electronic trial systems rather than introducing a completely new obligation.
"Ensure that the documents contained... are retained for at least 25 years"
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