How long to retain clinial trial records by investigators?

How long to retain clinial trial records by investigators?

The investigator should agree to archive the documentation (both electronic and paper-based records) during the retention period as required according to GCP 5.5.11 – 5.5.12. General practice is 15 years after end of trial or longer. If the investigator cannot archive the documents at the trial site, an independent archive provider can be used.

Subject’s medical records should be kept for the maximum period permitted by the hospital, institution or private practice.

The investigator should  be able to access his/her trial documents at all time without involving the sponsor in any way.

Site-specific CRFs and other subject data (in an electronic readable format or as paper copies or prints) will be provided to the investigator before access is revoked to the systems and/or electronic devices supplied by the sponsor. These data should be retained by the trial site.

If the provided data (e.g. the CD-ROM) is not readable during the entire storage period, the investigator should be able to request a new copy.

The investigator should not destroy any documents without prior permission from the sponsor.

A recent FDA warning letter highlights how the loss of source documents might be a violation of the regulations. Failing to retain the clinical trial records jeopardises subject safety and welfare, and also compromises the validity and integrity of the data collected at the site.

After receiving the sponsor’s approval for destruction at end of retention periode, the destruction process must also ensure confidentiality of data and in accordance with local regulatory requirements.

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