Version Date: November 2023
AAHRPP Element III.2.A
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HUMAN RESEARCH AFFAIRS
RECORDKEEPING AND RECORD RETENTION
REQUIREMENTS
GENERAL GUIDANCE
Investigators are required to maintain records of their human research activities. Good
recordkeeping is essential for verifying the integrity of study data produced and for
demonstrating investigator compliance with applicable regulations, and institutional policies and
procedures. The recordkeeping procedures outlined in this guidance document cover the
following two types of files:
A. Regulatory document files
B. Individual research subject files
A. Regulatory Document Files
Regulatory documents, also called Regulatory Binder or Essential Documents, must be
maintained for all research involving human subjects, which includes obtaining data through:
• Intervention or interaction with subjects;
• Access to identifiable private information in health/medical records; and/or
• Access to human materials/tissue collected for non-research purposes.
Regulatory document files serve as a central location for maintaining study management
documents and when complete and appropriately maintained/updated,they demonstrate
compliance with applicable regulations, and institutional policies and procedures. A separate
regulatory document file should be maintained for each study.
Note: The Mass General Brigham Compliance & Education Office provides tools and
resources for assembling and maintaining regulatory document files/Regulatory Binder.
For more information, visit the C&E Office website or email
All studies involving human subjects
Investigators must maintain the following study-specific documents for every research
study that involves human subjects:
1. A complete history of Mass General Brigham IRB submissions and correspondence
from initial application through study close out, including, when applicable, but not
limited to:
eIRB application forms
Protocol(s)
Protocol Amendments
Protocol Summary
Consent Form(s)
Recruitment materials
Any other documents approved by the Mass General Brigham IRB
Mass General Brigham IRB review notification letters
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Investigator response to review notification letters
Any other correspondence between investigator and Mass General Brigham
Note: Records of all Insight/eIRB submissions and related IRB review notification letters
created and submitted after April 6, 2013 are maintained in Insight, with limited
exceptions. Exceptions include, among others, records of IRB reviews ceded to another
institution or entity, original review notification letters when new letters are reissued and
replace the original in Insight, and documents or communications submitted outside
Insight. The IRB maintains copies of originals of reissued letters and can provide copies
upon request.
2. Sample case report forms (CRFs) and/or data collection forms
3. Completed study management logs or equivalent documentation of the following:
Delegation of responsibility / signature log
Enrollment/health/medical records/excess human materials (for studies limited to
accessing individually private information or samples)
Internal and if applicable, external monitoring activities
Protocol deviations and unanticipated problems including adverse events
4. Correspondence and/or communications with study sponsor, funding agency, regulatory
agencies, research collaborators (e.g., data use agreements, materials transfer
agreements, etc.)
5. Financial disclosure forms submitted by study staff responsible for the design, conduct
or reporting of the research (of note, the eCOI forms are only available in Insight and
only to the individual and the IRB, not to everyone on the study)
Studies that involve an intervention or interaction with subjects
In addition to documents 1-5 above, investigators must maintain the following documents
for studies that involve an intervention or interaction with subjects:
6. Completed study management logs or equivalent documentation of the following, as
applicable:
Pre-screening
Adverse events
7. Study staff qualifications
CVs of all study staff, dated
Current licensure and board certifications of professional staff
Safety or other training (e.g., infection control, laser safety, CITI, etc.)
Study specific training
8. Clinical laboratory certification (e.g., CLIA/CAP certificate) and normal reference ranges,
and research laboratory director’s CV, when applicable.
9. Correspondence and/or communications with collaborating sites (multi-site research)
Note: Study staff CVs, professional study staff licensure and board certifications, safety or
other training and laboratory certification and normal reference ranges that support more
than one study may be filed centrally for a research group/department.
Studies that involve FDA regulated drugs/biologics or medical devices
In addition to documents 1-9 above, investigators should maintain the following documents
for studies of FDA-approved or unapproved (investigational) drugs/biologics or FDA-
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approved/cleared or unapproved (investigational) medical devices:
10. Product information, to include, when applicable:
10.1 FDA-approved drugs/biologics or approved/cleared medical devices
Drug package insert
Device manual / Instructions for Use
10.2 IND drugs/biologics or IDE medical devices
Investigator’s Brochure (IB)
Device information / Report of prior investigations
11. FDA Forms, Submissions and Correspondence
11.1 IND/IDE Clinical Investigators (IND/IDE held by company, NIH or other
entity)
Form FDA 1572/Statement of Investigator (IND Investigator)
Investigator’s Agreement (IDE Investigator)
11.2 Sponsor-Investigators (IND/IDE held by Investigator)
IND/IDE submission
IND protocol amendments / IDE supplements
IND/IDE safety reports
IND/IDE annual reports
IDE updated list of investigators
Form FDA 1571/IND Application
Form FDA 3455/Disclosure: Financial Interests and Arrangements
of Clinical Investigators
Form FDA 3674/Certification of Compliance, with Requirements of
ClinicalTrials.gov
12. Drug/device accountability, to include, when applicable, records of:
Shipping and receipt
Dispensing to subjects
Return of drug/medical device by subjects
Return of drug/medical device to sponsor
Destruction of drug/medical device, when destroyed at the investigative site
Note: The research pharmacy maintains these records for most drug studies.
Investigators are expected to maintain investigational product accountability for each
subject as well as for the study overall. Sponsor-Investigators have additional
responsibilities related to the management and oversight of the investigational product
as outlined in the Sponsor-Investigator Responsibilities Guidance. When the study
does not utilize the research pharmacy, the above must be maintained by the
investigator. Areas, such as the operating room or catheterization lab, may maintain
records of medical device shipments, receipts and use. When someone other than the
investigator maintains information about medical device accountability, document this in
a signed and dated note-to-file.
B. Individual Subject Files
Investigators must maintain the following study-specific documents in a separate file for
each subject who signs the consent form or provides oral consent (written documentation of
informed consent is waived), as applicable:
All original signed and dated consent forms
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Documentation of informed consent when written informed consent is waived
Documentation of the informed consent process, whether consent was provided with
a signature or orally
Documentation of subject eligibility and study procedures
All case report forms (CRF) and data forms, signed, dated and complete
All instruments, questionnaires, diaries, or other documents completed by subjects
and/or study staff
Correspondence, emails or phone calls to subjects
Adequate and accurate source documents and trial records. Source data should be
attributable, legible, contemporaneous, original, accurate and complete.
For studies limited to health/medical records, excess human material, secondary use, or a
data or tissue repository, subject files may be more limited in nature, depending on the
protocol.
Note: Research subjects cannot request that study data be “deleted” or “erased” once it has
been collected. Contact the Human Research Office for guidance should a subject request
that data collected about them be destroyed.
Record Storage and Retention
Study documentation may be collected, recorded and stored in physical (paper) or electronic
form. Regardless of the form, investigators are responsible for storing study documentation
securely to preserve the integrity of the records, protect identifiable health information and
maintain the confidentiality of the data. Access to study documentation should be limited to
study staff. Study documentation must be available for internal audits, external monitoring, or
inspection by regulatory agencies.
Physical (paper) records should be stored in a secure area, such as in a locked file cabinet.
Electronic records may be stored on Mass General Brigham and Institutionally compliant
computers or mobile devices or other internally hosted services. Investigators should follow
Research Information Services & Computing (RISC) recommendations to safeguard electronic
protected health information (ePHI) when storing individual subject files electronically.
Research records should be retained for at least seven (7) years from the time the study was
completed, or longer as required by the sponsor. For FDA regulated clinical investigations
conducted under an IND/IDE, the sponsor of the IND/IDE is responsible for informing
investigators when the study records can be destroyed. If the investigator leaves the institution,
all such original permanent records must remain in the laboratory or unit, unless alternative
arrangements are approved by the principal investigator’s Department Chair/Chief or designee.
