25.2 Retention, Destruction and Long-Term Access

Retention, Destruction and Long-Term Access

A site may hold source in an EHR, administrative records in an electronic ISF and laboratory outputs through another system. A sponsor may hold trial-level records in several controlled repositories. Record locations and links need to remain understandable. Unnecessary duplicate copies can create version confusion, while a broken reference can make essential evidence unavailable.

Original records generally remain with the responsible party that generated them. Some records belong only with the investigator/institution because they contain confidential participant information; some concern sponsor activities; others are relevant to both. Determine what each party needs to retain rather than forcing every repository to mirror the others. Preserve confidentiality and blinding when sharing relevant records.

Paper and electronic preservation

When a certified copy permanently replaces an original essential record, it should preserve the same information, including relevant context, content and structure. A PDF export may omit attachments, electronic signatures, audit history or dynamic information. Assess what is necessary and verify the conversion or migration. A visible page count alone is weak proof of a complete record.

A portal-closure example

A sponsor notifies a site that its study portal will close next month. The portal contains safety communications the investigator needs to retain and relevant training records. The site should identify what must be preserved, establish the authorised export/retention method, verify completeness and readability, and document the location. Downloading a few screenshots at the last minute can lose context and leave no reliable retrieval index.

If the portal also contains material the site should not receive, use an appropriately scoped transfer rather than a full unrestricted export. Preserve necessary attribution, dates and version history. The sponsor and institution should agree responsibilities and resolve failures before access ends. A closed vendor account is not an explanation that makes missing essential records acceptable.

Custodian and organisation changes

Investigators retire, institutions merge and service providers change. Maintain a current responsible contact and update relevant parties when custody or record location changes. The retention obligation should survive staff turnover. A personal laptop or former employee's password is not a durable institutional archive.

If sponsorship changes, preserve ownership/transfer records and inform the relevant parties as required. Verify that source access, trial data and ongoing participant support are not interrupted. A new sponsor should be able to understand the history rather than receiving only the latest cleaned-up documents. The CRA can identify and track gaps while responsible sponsor/institutional functions manage the transfer.

Controlled destruction

Before disposal, establish that applicable periods, sponsor needs and relevant holds have ended. Obtain required authorisation, identify the records and method, protect confidential information and document the disposition. Sponsor release cannot override a longer applicable legal requirement. Storage cost, a closed trial account or an expired software subscription does not itself authorise deletion.

Data and metadata may have linked retention needs. Deleting an audit trail while retaining final values can destroy the ability to explain corrections. Destroying specimen material and destroying associated clinical records are separate decisions. Follow the protocol, consent, applicable requirements and authorised retention process for each.

Monitoring verification

At close-out, verify more than an address on a checklist. Ask how a record will be requested, who will approve access, how retrieval will work and how electronic readability will be maintained. Review documentation supporting any migration and outstanding issues. Record the custodian and escalation route so a later inspection can obtain reliable evidence.

A sound archive preserves an honest history, including deviations and unresolved limitations. Do not remove superseded versions, signed forms or inconvenient correspondence to reduce storage. Traceability and appropriate accessibility are the purpose of retention; a neat binder that no longer explains the trial does not meet that purpose.

Testing future retrieval

An archive plan should be practical for someone who did not work on the trial. Select a representative record and establish how an authorised reviewer would locate it, request access and interpret the relevant attachments and metadata. Verify that the responsible institution can support the process after staff or vendors change. A backup demonstrates a potential recovery copy; it does not by itself establish that the record can be read and reconstructed. Appropriate testing and documented resolution of retrieval problems provide stronger assurance than a storage address or an untested promise of continued access.

Official sources

Checked October 18, 2026: ICH E6(R3), Principles and Annex 1.