Investigators are required to maintain records of their human-subjects research activities. Good records are essential for verifying the quality of study data produced and demonstrating investigator compliance with good clinical practice guidelines and applicable regulatory requirements. In general, investigators should establish two sets of files for each study:
- Regulatory documents
- Study subject information
I. Regulatory Documents. Regulatory documents should be maintained for all studies, regardless of sponsor/funding source, or whether the research is funded. These documents are typically organized within a regulatory binder, either paper or electronic. Some documents that may be common to more than one study, such as CVs and professional licenses, may be filed centrally. The regulatory binder should contain the essential documents listed below.
Basic regulatory documents required for all studies (non-funded, non-FDA-regulated, non-published):
- CVs document qualifications and eligibility to conduct a study and provide supervision of subjects. CVs should be signed and dated. It is recommended that CVs be updated every two years to verify that the information is accurate and current.
- Valid licenses and certifications for all professional study staff
- Mandatory human subjects protection training such as CITI.
- Institution’s financial disclosure form: signed/dated copies of financial disclosure for all investigators and staff listed on the protocol.
- Staff Signature/Delegation of Responsibility log: documents the signature and initials for all staff that collect and record study data, and lists the study-related procedures each has been delegated by the Principal Investigator
- Protocol: all versions should be numbered and dated
- Initial submission; Continuing reviews; Modifications/Amendments
- Copy of all IRB-approved versions of the consent form and assent form (if applicable).
- Blank copies of all data collection forms, questionnaires, CRFs, and/or study instruments.
- Recruitment materials
- Educational materials or other study information designed for subjects
- IRB Correspondence:
- All IRB correspondence including approval letters and/or notifications
- IRB-approved recruitment materials
- IRB-approved educational materials or other study information distributed to subjects
- Monitoring Records: document any study-related activity performed to monitor study progress or the accuracy and completeness of study records.
- Data Safety and Monitory Board (DSMB) reports
- Sponsor monitor reports
- Audit reports, internal and/or external
- Laboratory documents (if applicable): These materials document the competency of all lab facilities being used in the study and support the reliability of test results.
- Updated copies of laboratory certification,
- The Lab Director’s CV
- The normal lab/reference values
- Reportable Events:
- Any study violations/deviations
- “On-site” adverse events
- Unanticipated problem reports
- Others (if applicable):
- Radiation Reports
Additional regulatory documents required for Funded, non-FDA regulated studies:
- NIH/Funding agency grants applications and progress reports.
- Correspondence/contract with study sponsor/funding agency.
Additional regulatory documents required for FDA-regulated investigational drug or device studies:
- Policies and procedures for dispensing, security, and storage of study drugs/devices.
- Copies of all Form FDA 1572s (Statement of Investigator) and Form FDA 1571s (Investigational New Drug Application), if applicable.
- Drug/device shipment and receipt records (may be maintained by the Research Pharmacy or Investigational Drug Service (IDS)).
- Drug/device accountability log (drug accountability log may be maintained by the Research Pharmacy or IDS).
II. Study Subject Information
- General Subject Information
- Potential subject/Screening log: capture s all potential subjects who appear to be qualified for the study.
- Enrollment/Randomization log: captures all subjects who have signed an IRB-approved consent form or, with IRB approval, have given verbal consent or had informed consent waived; and have been randomized if applicable.
- Individual Subject Files: There should be a separate file for each subject enrolled in or screened for a study. The following documents are placed in each file:
- An eligibility checklist, signed and dated by the person determining eligibility, lists specific inclusion/exclusion criteria. Copies of source documentation to support medical criteria should be available in the subject’s medical record, and retained to corroborate entries on the data collection instruments.
- Original signed and dated consent form
- Individual case report forms (CRF)
- Study instrument(s) used to capture all data required by protocol for each subject, such as data collection forms, questionnaires, and/or subject diaries
- Subject Compensation Documentation
- A full accounting of all funds provided to subjects.
As per Federal Regulations, the HHS protection of human subjects regulations require both institutions and Principal Investigators to retain research-related records. The institution must maintain records of IRB activities and certain other records frequently held by investigators for at least three years after completion of the research (45 CFR 46.115(b)). In addition, other regulations may apply and require retention of these records for a longer period of time.
Documentation of the informed consent of the subjects - either the signed informed consent form, the short form or signed assent form in addition to other project related materials including the written research summary must be retained by Principal Investigator for at least three years after completion of the research, unless the IRB waived the requirement for informed consent or the requirement for documentation of informed consent (45 CFR 46.117).
If investigators have been designated to retain certain records (e.g., informed consent documents signed by subjects) on behalf of the institution as required by the HHS regulations at 45 CFR 46.115(b), they must retain the records in some form. Such records may be preserved in hardcopy, electronic or other media form (e.g,. on a secure cloud or encrypted hard-drive) and must be accessible for inspection and copying by the IRB or authorized representatives of HHS at reasonable times and in a reasonable manner (45 CFR 46.115(b)). Retention of multiple copies of each record is not required. Investigators must comply with all Rutgers policies and procedures for retaining records.
HIPAA Requirements: Disposal of Protected Health Information
HIPAA Requirements: Research that involves collection of protected health information (PHI) is subject to the HIPAA regulations. Research records including signed consent forms that contain the HIPAA authorization must be retained for 6 years after the date on which the subject signed the consent form or the date when it last was in effect, whichever is later.
If a research project is funded or sponsored, then the investigator must also comply with the terms for record retention outlined in the contract with the sponsor or with the study funder's requirements.
Recordkeeping and Record Retention Requirements
Records Retention At-a-Glance: Below is the minimum requirement for research record retention. However, the University recommends maintaining these records indefinitely.
|Category||Study Type||Retention Period||Relevant Source/Citation|
|1||Non-funded, non-FDA regulated, non-published||Three (3) years after completion of the research||45 CFR 46.115(b) Protection of Human Subjects1|
|2||Funded, non-FDA regulated||Minimum of five (5) years after completion of the study or publication of the results, whichever is later, and preferably indefinitely||Legacy UMDNJ Guidelines2|
|3||HIPAA authorization||Minimum of six (6) years or until authorization expires||45 CFR 164.530 Security and Privacy3|
|4||FDA regulated – Investigational drug or device||Two (2) years after the investigation is discontinued and FDA is notified, following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or the application is not approved for such indication. However, these documents should be retained for a longer period if required by the applicable regulatory requirements or by an agreement with the sponsor.||21 CFR 312.62 FDA - Investigational New Drug Application4|
|5||ICH compliant||Two (2) years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product. However, these documents should be retained for a longer period if required by the applicable regulatory requirements or by an agreement with the sponsor.||ICH E6 4.9.5 GCP: Investigator – Records and Reports5|
|6||Pediatric/Minor Research||Until age 18 or in accordance with guidelines listed above whichever is later|
Destruction of Data / Records After Retention Period
Rutgers University Records Management (Document Archiving and Destruction)