Education Module
Auditing in Clinical Research
Introduction
This module utilizes a series of short case studies to describe serious audit findings and possible preventive solutions.
Who Might Audit Your Studies?
There are four primary types of audits. These include internal audits, sponsor or sponsor designee audits, federal agency audits, and research compliance (Institutional Review Board) audits. A brief description of each type of audit can be found below.
- Internal audit – audit completed by a member of the research team or department
- Sponsor/Sponsor Designee audit – drug or device company, pharmaceutical company, or a third party hired by one of these companies
- Federal Agency audit – Food and Drug Administration, Office for Human Research Protections
- Research Compliance (IRB) audit – Agent designated by the institution’s Institutional Review Board office
Serious Audit Findings – A Series of Case Studies
Case Study 1: Lack of Documentation of the Consent Process
Note: Written notation should be made in the medical and/or research source record to document that the consent process occurred.
Possible Preventions: (1) to prevent a lack of documentation of the consent process, incorporate notes regarding the consent process into progress notes, nursing notes, etc; (2) use a separate template form to document the consent process.
Case Study 2: Not Using the Current Version of the Informed Consent Document
Note: After the Institutional Review Board reviews and approves the consent document(s), it will be stamped with a new approval and continuing review due date. This newly stamped consent document becomes the current consent document for the study. This version must be signed by all future research participants, until a revision is made and approved by the Institutional Review Board.
Possible Preventions: (1) Develop tracking methods for versions of the informed consent document(s) (i.e., electronic tracking system, accessible to the entire research team); (2) scan the newest version of the informed consent document(s) and post it for printing in a manner that is easily accessible to all who need it.
Case Study 3: Source Documentation that is not Appropriately Signed and Dated
Note: Case report and data collection forms typically represent the summary or collation of data from the original source documents. While these are not the original source documents, they may be used as such and must be signed and dated by the original observer/recorder.
Possible Preventions: (1) create forms with identified areas for signatures and dates when possible; (2) conduct internal audits to recognize these deficiencies early in a study to create a procedure(s) to prevent them; (3) sometimes it is possible to obtain one signature for an entire set of data – this can be utilized when one person is creating the information and it is all on the same date (i.e., principal investigator assessing adverse event relationships).
Case Study 4: Closure of Study or Lapse in Approvals While Study-Related Activities are Still Ongoing
Note: Oversight by the Institutional Review Board is required as long as investigators are either interacting or intervening with research participants for research purposes, or accessing identifiable information for research purposes.
Possible Preventions: (1) ensure that the entire research team is aware of this requirement; (2) obtain documentation from the study sponsor that they recognize and agree that when the study is closed with the Institutional Review Board, identifiable information will no longer be available.
General Prevention Measures
There are a few general prevention measures that will help to ensure that serious audit findings are not found: (1) ensure that all research team members are educated in research compliance on an ongoing basis; and (2) keep all documentation related to the research organized, easily accessible, and easy to follow up; (3) principal investigators should hire and train responsible and detail-oriented research coordinators.
Question & Answer
This question and answer section is designed to test your knowledge of audits in clinical research. Answers are provided so that you can ensure you know the right answer. No credit is given for completing these questions.
Question 1
Question: True or false. An external funding agency can audit a research study it is sponsoring?
Answer: True.
Question 2
Question: Which of the following are serious audit findings?
A: Lack of documentation of the consent process
B: Not using the current version of the informed consent document
C: Source documentation that is not appropriately signed and dated
Answer: All of the above.
Question 3
Question: What do you do if you are using a consent form dated on March 1 and you have submitted a revised consent form, but it is not yet approved. Do you use the unapproved revised consent form, or the consent form that has been approved, dated, and stamped?
Answer: The consent form that has been approved, dated, and stamped should be used. Revised consent forms should not be used until they have been approved.