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Preparation and Maintenance of a Research Audit File

Purpose of a Research Audit

To preserve subject welfare and integrity of research data, various internal and external entities may request access to a Lead Researcher's study records for purposes of conducting an audit. Audits may be conducted for cause (i.e., to investigate an allegation) or for quality control purposes.

Examples of internal entities that may audit research records are the:

  • UCI IRB and Office of Research Administration staff,
  • UCIMC Office of Clinical Research Oversight and other authorized UCIMC personnel;
  • UCI Office of Internal Audit

Examples of external entities that may audit research records are:

  • U.S. Food and Drug Administration,
  • Office for Human Research Protections (OHRP), and
  • For-profit sponsors of research (such as pharmaceutical companies)

External Audits

Any time an audit of study records is conducted by an external entity other than the UCI IRB, it is the responsibility of the Lead Researcher to inform the IRB promptly. If the Lead Researcher is given notice of an audit by an external entity, the IRB may send a representative to observe proceedings of any "exit interview" which may occur. Finally, the written report of any audit findings for a UCI study must be forwarded to the IRB for their records.

When UCI personnel receive notices about external audits (on-site and remote), they should immediately contact Internal Audit Services (IAS) at 949-824-7459 or 949-824-6757.  A copy of the Sponsor's audit notification letter should be sent to Loran Lerma (LLerma@uci.edu).

Documentation

Documentation is an integral and important component of conducting research with human subjects. From the first draft of a protocol application to the completion of a study, much that occurs in between is dependent on the consistency, accuracy and accountability of the study's accumulated documentation (e.g., correspondence between the investigator and the Institutional Review Board, a study sponsor, a funding agency, regulatory agencies; various reports including case report forms, personal and/or medical information on subjects, etc.).

Suggested Ways to Organize Documents

The following is provided to assist investigators and their staff to organize the numerous documents, making them easily retrievable when needed. (In funded studies, sponsors may require such files, maintained in a specific fashion.) Although the information provided below is weighted toward clinical studies, variations of it can be employed in almost any research study with human subjects.

  • All files should be kept in one designated area (e.g., the Lead Researcher's office, lab, etc.)
  • All documents should be maintained in chronological order. A sturdy three ring binder, containing dividers with some or all of the following headings (depending on the study), is recommended; however, researchers may also consider maintaining their records electronically:
    • Sponsor Correspondence if the study is formally funded or sponsored (e.g., NIH, NSF; drug/device company).
    • Investigator's Assurance and other forms, such as the HHS form 596 and/or FDA 1572, 1573, 1574 forms.
    • IRB Approvals*

*IRB Approvals can be subdivided, as follows:

  • Initial Approval
    • Retain and insert a copy of the original IRB application form, signed by the Lead Researcher, faculty sponsor (if necessary) and Department Chair.
    • The original IRB approval letter.
    • A copy of the final, IRB approved, dated protocol along with any amendments. ** (If there is a "master" protocol, it, along with revised sections, might also be filed separately under the heading "Master Protocol" toward the back of the file, or in a separate binder.)
  • Modification Forms - Requests/Approvals
    • Include a copy of the e-IRB modification form submitted electronically by the Lead Researcher.
  • Continuing Review - Applications/Approvals
    • Include a copy of the continuing review application signed by the Lead Researcher. Add (clip or staple) the new, original IRB approval letter covering the next approval period as well as the original, stamped consent form.
  • Adverse Event Reports - "AEs"
    • Include a copy of each, noting the dates that each report was sent to the IRB, sponsor, FDA, etc. If any change to the protocol or consent form is made as a result of adverse experiences, maintain a copy of the changes with the pertinent AE reports.
  • Approved Consent form(s)
    • Include a copy of each (if there are more than one) approved consent form (with the IRB's stamp affixed thereon). **The most currently approved consent form is the one from which copies are to be made when enrolling new subjects.
    • If the consent form requires revision during the course of the study, retain the original in the file and send a copy of it with a revised original for IRB review and approval.
    • To avoid the possibility of using an obsolete version, retain the most currently approved version on top, and draw a diagonal line through each page of the obsolete version when the newly approved one is received.
    • Subdividers can be used to separate years (e.g. 2001 approval, 2002 approval, 2003 approval, etc.) for studies which will continue over several years.
  • Approved Advertising (when applicable)
    • Maintain a copy of each advertisement (including flyers, posters, "scripts," etc.) approved for use by the IRB (and containing the IRB stamp).
    • Notes can be made on each advertisement showing when it was placed and where. Any correspondence relating to advertising can be maintained in this section as well.
  • Study Closure/Completion
    • Complete the "IRB Closing Report" and submit it to the IRB to close a study. The report must be submitted by the Lead Researcher electronically.

** For documents approved prior to June 2008, the Lead Researcher should keep the original purple stamped copy for the research record.

In studies sponsored by a drug or device company, the following, additional sections will likely be required:

  • Subject Enrollment/Assignment Log
  • Drug Dispense/Return Log and Drug Receipt/Ship Log
    • These will be the originals received from the sponsor for drug receipt, dispensing date, drug count, and final return.
  • Shipment Receipts/Lab Supplies
    • If the study requires that samples be sent to a central lab, or if the sponsor provides lab supplies (special catheters, test kits, etc.) the accompanying invoices, shipment logs, or UPS/Fed Ex receipts will need to be retained.
  • Monitor Visit Log (as applicable)
  • Master Protocol
    • As mentioned previously, a large, bulky master protocol may be maintained in a separate section.
    • When revisions/amendments to protocols are made by a sponsor, most sponsors will provide investigators dated replacement pages. Unless the sponsor specifically requires the old pages be discarded, it is suggested that a horizontal line be drawn through the page(s) or section(s) being revised and the new information inserted.
  • Sponsor Agreement(s)/Contract(s)
    • This material should include the UCI Sponsored Projects (SP) Administration Clinical Study Agreement, signed by SP officer and the sponsor, and any other documents pertaining to agreements between the institution and the sponsor relative to performance of the study.
  • Miscellaneous
suggestions and comments