Adhere to storage requirements
- 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.
- 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 a NDA will not be submitted by the sponsor.
- The industry standard for record retention is 15 years, 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 7 years to satisfy PHRC (Partners IRB) requirements, and may be retained for up to 15 years if your study involved an investigational drug or device.
- Be sure to include document storage in your study budget. Partners' current preferred vendor is Access.
- Keep written documentation of exact location of files in storage and who will have access to them. This will facilitate any needed retrieval despite study staff turnover.
▪ Code of Federal Regulations: Investigational New Drug Investigator Record Keeping and Retention (21CRF312.62)
▪ Code of Federal Regulations: Investigational New Drug Record Keeping and Retention (21CFR312.57)
▪ ICH E6 Good Clinical Practice
▪ Partners Human Research Committee Guidance for Investigators: Recordkeeping and Record Retention Requirements