PSC Column: Record Retention in Clinical Trials. . . . Where are they now?
Written by Erin McCaig, RN, BSN, Lead Clinical Research Nurse, Cancer Research for the Ozarks, Springfield, MO; and
Mary Gulzow, CCRP, Office of Research Sponsored Programs, CommonSpirit Health, Englewood, CO
Have you ever wondered where those heavy, multivolume paper filled charts are? Or have you ever visited your research chart storage facility to locate an archived chart? Or have you ever wondered, what is the purpose of keeping these dusty charts anyway?
Retention of research records refers to the practice of storing and preserving research data and documents for a specified period of time after the completion of a research project. This typically follows guidelines set by federal agencies, ethics boards and institutional policies. The guidelines may vary depending on the type of research. Record retention is required for potential future analysis, verification, grant monitoring and audit purposes. Researchers have a responsibility to maintain accurate and complete research records that comply with legal and ethical standards especially when dealing with human subjects and sensitive data. Maintaining the records allows for proper review and access to study data in case of post-market analysis, regulatory inquiries or legal allegations.
What are the records to be retained?
Relevant study documents of participants such as case histories, signed informed consents, medical records, drug disposition records, films, photographs, audio recordings, protocols, as well as all regulatory compliance and study activity requirements, should be retained until the complete retention period has been obtained.
What are the retention periods?
Research record retention guidance time periods are exceedingly difficult to provide and should be reviewed on a specific study basis. Researchers must comply with the longest applicable standard.
There are several factors and agencies that influence the retention period.
- Regulatory Agency requirements: Food and Drug Administration (FDA), National Institutes of Health (NIH), Office of Human Research Protections (OHRP), U.S. Department of Health and Human Services (HHS), Department of Veteran’s Affairs (VA)
- Research Type: Investigational new drugs and devices versus minimum risk or exempt.
- Domestic versus international research
- Funding Agency guidelines: Grant funding
- Good Clinical Practice (GCP)
- Health Insurance Portability and Accountability Act (HIPAA)
- State laws
- Institutional Review Boards (IRB)
- Independent Ethics Committees (IEC)
- Sponsor requirements and policies
- Institutional policies
| Food and Drug Administration (FDA) | 2 years following the date a market application is approved for the drug in the investigated indication or 2 years after the investigation is discontinued and FDA is notified |
| Office of Human Research Protections (OHRP) | 3 years after the completion of the research (45CFR46) |
| Department of Veteran’s Affairs (VA) | Research that involves the VA must be retained INDEFINITELY. This may change if regulators establish a national policy. |
| Health Insurance Portability and Accountability Act (HIPAA) | Minimum of 6 years for research that involves collecting identifiable health information |
| National Institute of Health (NIH) | 3 years after grant application completed including all litigations, claims and audit findings |
| National Cancer Institute IRB (CIRB) | 3 years after the completion of the research |
| NRG Oncology | 2 years after approval for the indication for investigation new drug/device and study termination for non-IND studies |
| Sponsor: International Breast Cancer Study Group (IBCSG) | 15 years after trial completion or written notice from IBCSG |
Though many state laws vary, most providers in the United States are required to keep adult medical records for seven years.
How to manage research record retention?
Records must be accurate, complete, legible, and maintained in a way that preserves their integrity throughout the retention period. Trial master files should be kept in a secure and accessible storage method appropriate for the data type. Records may be on several means of electronic and digital storage media as well as archival long term storage of paper. Since facilities and research sites have had several software and electronic medical record program changes as well as multiple physical location changes, care should be taken to provide detailed location of records and access. Allowable personnel access is required to be managed and maintained according to policy while still restricting access to sensitive data.
Records should be stored in a secure location with proper environmental controls to prevent damage from temperature fluctuations, humidity, or natural disasters. For example, if your site is working with monitor strips on slick paper, you should consider a means of safeguarding the information so that the media does not deteriorate. A good practice is to consider the available options of the information as digital or physically tangible. As always, clear site standard operations for secondary means of the original documentation will be required.
Once a study is officially closed, some sites may elect or be required to transfer paper records—such as patient charts, regulatory binders, and pharmacy files—to an off‑site storage facility. Institutions often formalize this process in a written standard operating procedure (SOP) that outlines key details, including the storage vendor used; requirements for inventorying and labeling records; procedures for scheduling document pickup; methods for requesting records if retrieval is needed; and the physical address where documents are stored.
NRG Oncology published a guidance May 8, 2024, titled, “NRG Oncology Records Retention Guidance for NCTN & NCORP Trials.” References are provided in the document for Record Retention for IND Studies, Record Retention for Non-IND studies and Record Retention for sites in Canada. Please inquire with your local and state agencies as well as the study sponsor for appropriate study record retention.
https://nrgoncology.org/wp-content/uploads/2025/09/NRG-Record-Retention-Guidance-08May2024.pdf
8.4.2 Record Retention and Access
Record Retention | Johns Hopkins Medicine
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