Regulatory Binder and Audit Process | IRB
The following information regarding IRB Regulatory Binder requirements and the Audit Process apply to all human subjects researchers who received an Expedited or Full Board Review. Should you be selected for an Audit, the Audit Committee will guide you through the process. All currently active research projects will be required to adhere to these Regulatory Binder and Audit policies. These policies exist to support researchers and the University in meeting federal, local, and University regulations to ensure ethical and appropriate research.
The IRB Audit Committee exists to help investigators and the University as a whole, achieve and maintain compliance with federal regulations governing human subjects research. The Audit Committee is a division of the Institutional Review Board in the Office of Scholarship and Sponsored Projects. This division is responsible for the development and administration of compliance programs required by federal and state agencies and programs in order to conduct research at Pacific University. The Audit Committee’s responsibilities include, but are not limited to, providing support for training activities, locating appropriate outside experts, and monitoring research activities carried out under state, federal, and institutional regulations.
The conducting of audits of human subjects research projects is a component of the internal audit services provided by the Audit Committee. These audits will include random audits and “for cause” audits. The IRB may request that the Audit Committee conduct an audit based on a PI's protocol activities (large numbers of active protocols where oversight may be diminished, subject enrollment, reported protocol deviations and/or serious adverse events). Audit findings will be reported to the Institutional Official and the PI.
Should your study be selected for an audit, there are specific procedures that you will be asked to follow. Procedures and guidelines are available to the human subjects research community in IRBNet.
Mission of the Audit Committee
The mission of the IRB Audit Committee at Pacific University is:
- To protect all of our research participants
- To educate our investigators in the conduct of research that is safe, effective, and in compliance with federal, state, and institutional requirements
- To maintain a comprehensive and integrated compliance program that is facilitative and educational for the research community and provides Pacific University the assurance that research is being conducted ethically and in compliance with the above requirements
The Audit Committee achieves this mission primarily through supporting the other program areas within Pacific University by providing the necessary and independent internal compliance auditing and investigation functions. The Audit Committee also collaborates closely with OSSP and the IRB to identify and facilitate many of the institution’s research-related education and training needs.
Types of Audits
There are two types of audits, routine audits and for-cause audits. Audits are often performed by the sponsor, the IRB, the FDA, or an internal quality assurance department. The goal of an audit is to review, inspect, and verify the ethical conduct of human subject research, integrity of previously reported data, adherence to the study protocol, and applicable institutional, state and federal regulations. Most audits involve the review and inspection of the following to ensure protocol compliance:
- informed consent forms
- documentation of the consent process
- reported data
- regulatory records
- source documents
- research team’s credentials and documentation of training to ensure appropriate delegation of specific research tasks.
Description of Audits
Audits are performed on active research studies involving human participants. Internal audits serve two primary functions: (1) to provide support to investigators in the process of research and (2) to identify difficulties with the conduct of research at the earliest possible moment to proactively institute individual and system level changes to ensure that all human subjects research is conducted to the highest ethical standards and in compliance with all applicable federal, state and institutional requirements.
How are studies chosen for an Internal Audit?
- Random − based on a list of approved studies within the IRB
- Directed − requested by the IRB or OSSP for oversight
- Investigation − resulting from an allegation or concern of noncompliance
- Educational/process improvement − investigators request the IRB to perform an audit of their study.
For-cause audits may be conducted if during the monitoring process a sponsor has documented accounts of possible noncompliance, data discrepancies or concerns over the ethical conduct of the study by the investigator. The sponsor may contact the FDA and report these concerns which could result in a for-cause FDA audit. Study participants could also contact the FDA to report suspected wrong doing that may lead to a for-cause audit. The IRB and sponsor can also perform a for-cause audit. The items reviewed in a for-cause audit are similar to those reviewed in a routine audit. An investigator will receive notification of an external audit and should consult with the Pacific University IRB for assistance in preparing for the audit. The Internal Audit Process can provide helpful guidance for maintaining study materials and preparing for an audit.
There is a high probability of an audit if a site is part of a multi-center study and is one of the top enrollment sites, one of the first sites to begin recruitment, or part of a pivotal phase III study. A pre-audit is often performed by sponsors in preparation for a potential FDA audit. Sponsors may also conduct audits to ensure the monitors assigned to the projects are performing to their expectations. Some sponsor auditors will not provide the site with a written report of their findings but the monitor will follow-up with the site on any of the issues noted.
FDA audits are conducted to ensure the quality and integrity of data submitted to the FDA. Most often, studies audited will be those that are instrumental in the attempt to prove the safety and efficacy of a product for FDA approval. Often the site will be contacted by the FDA inspector and be given minimal notice prior to the audit. However, the FDA may conduct an unexpected audit at any time.
The FDA audit findings often report a failure to maintain adequate and accurate case histories, protocol noncompliance, failure to appropriately obtain informed consent, untimely reporting of SAEs to sponsors and IRBs, enrolling ineligible subjects, inappropriate delegation of research tasks to under-qualified research staff and failure to list all sub-investigators. The audit findings will be discussed with the research team at the conclusion of the audit visit. Upon completion, the FDA inspector will report their findings and an official letter will be sent to the clinical investigator. The official letter will provide detailed information about the finding and any action that is required by the PI.
Further information can be found at:
- OSU Investigator Guidance for Inspections http://orrp.osu.edu/irb/guidance/FDAInspection.cfm
- FDA Compliance Program Manual www.fda.gov/ora/cpgm/default.htm
Preparing for an Audit
The following guidelines apply to Internal Audits conducted by the Pacific University IRB Audit Committee; however, these recommendations will also aide in preparations for an external audit.
The research team should always be prepared for a potential audit. It is essential that there are written, approved, and enforceable department policies and SOPs for how the study team should conduct human subject research. All staff should have adequate and documented training on key policies and processes. The research team should also be aware of proper audit etiquette and present themselves in a calm and professional manner at all times. Maintain an up-to-date Regulatory Binder and Data (see below).
Self-Audit in Preparation for your Audit
The PI will receive an Announcement of Audit Letter (see linked document for an example). This Letter will contain information regarding the date of the audit and the necessary steps to follow. The IRB Audit Committee uses IRBNet to facilitate the audit process. Please refer to the IRBNet Audit Instructions for step-by-step instructions.
To prepare for an upcoming audit, it is helpful to review all research charts, consents, regulatory documents and source documents for accuracy and completeness. This will allow the team to be prepared for any deviations that the auditors may note during their review.
All necessary research charts and records, access to electronic records, and regulatory documents should be requested and available upon the day of the audit for inspection. All records and charts should be organized in a similar manner to allow for easy review. It is helpful to develop a flagging mechanism so that all pertinent documents are identified and easy for the auditors to find. It is in the research team’s best interest to have everything as organized as possible. The specific requirements are detailed in documents you will receive should you selected for an Audit.
The date of the audit will be set by the IRB Audit Committee, but in the event of an external audit, the IRB Audit Committee will help facilitate arranging for a meeting room and other necessary resources.
All human subjects researchers are required to maintain a research study binder (“Regulatory Binder”) that contains all the essential documents for the conduct of human subjects research as mandated by applicable federal regulations and institutional policy (this can be either hard copy or electronic). The required components and means of storage of the Regulatory Binder are detailed in the Regulatory Binder: Preparation and Maintenance document housed in IRBNet. This SOP provides general information about record keeping and serves as a checklist and location log for all required materials. The IRB has provided all Regulatory Binder information and an e-Regulatory Binder template in IRBNet.