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Research records should be stored according to the Partners Human Research Committee (PHRC) Record Keeping and Record Retention Requirements for at least seven years after the completion of the research study, or longer if required by the sponsor. After seven years, contact your industry sponsors at least annually to find out when study documents can be destroyed.

United States Food and Drug Administration (FDA) regulations state that study records must be stored for at least two years past the date of approval of a new drug application (NDA) or discontinuation of the research study, if an NDA will not be submitted by the sponsor.

The industry standard for record retention is 15 years from the end of the study, which is based on the international region that takes the longest time to approve a new drug.

Considering the various record retention requirements that exist, your records must be kept for a minimum of seven years to satisfy PHRC requirements, and may be retained for up to 15 years if your study involved an investigational drug or device.

Be sure to include the cost of document storage in your study budget. Partners HealthCare’s current preferred vendor is Access.

Keep written documentation of the exact location of files in storage and who will have access to them. This will facilitate any needed retrieval in the case of study staff turnover.

Learn More

The Clinical Research Program (CRP) at Massachusetts General Hospital helps to connect investigators and study staff members to a variety of courses, services and resources that provide assistance with every step of the clinical research process. These include offerings from the CRP itself, as well as associated research institutions and organizations. Mass General resources are listed first; CRP programs are noted in parentheses.

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