Section 1 - Preparation for an audit begins before the study is initiated
- Know and observe applicable federal regulations, state law and institutional SOPs and/or policies as well as good clinical practices.
- Minimally, have a basic understanding of the therapeutic area and indication for studies conducted in your department.
- Know and observe your department's policies and procedures for research study-related activities.
- Know and follow the IRB-approved protocol.
- Know the study-related roles and responsibilities of the principal investigator and other research team members.
- Differentiate between the study-related and healthcare provider roles and responsibilities.
- Review the protocol with the research team members, identify and discuss any concerns or questions regarding conduct of the study.
- Maintain open communication lines with other research team members and investigators, the principal investigator, sponsor and IRB.
- Ensure that each research team member has access to the most current documents, including, but not limited to, the informed consent document, protocol, and case report forms.
- Assist in the establishment and tracking of the budget.
- Create and use tools to assist in the compliant conduct of the study (worksheets, data collection forms, logs, checklists, etc).
- Develop and maintain an effective system for data collection and storage.
- Implement quality assurance measures to ensure your study is conducted in accordance with the IRB approved protocol, institutional policy, and required regulations. Examples of quality assurance activities may include, but are not limited to:
- Confirmation of IRB approval before initiation of study–related activities.
- Use of the current IRB approved consent form in the consenting process.
- Verification that the potential study subject meets all of the eligibility criteria and none of the ineligibility criteria.
- Verification that all study activities have occurred in accordance with the IRB approved protocol.
- Verification that deviations from the IRB approved protocol are addressed in accordance with the IRB approved protocol, federal regulations and institutional policies.
- Confirm that the source documentation and study-related documentation verify the conduct of study activities and recorded research data.
- Develop and implement a system for organization of the documents found in study participant file to help maintain the file in order and up to date.
- Develop and implement a system for organization of the documents found in the investigator’s study regulatory file to help maintain the file in order and up to date.
- Create and utilize a study participant file which is a central location of documents including, but not limited to:
- signed informed consent
- documentation of eligibility criteria, case history, assessment and evaluation of the study participant
- documentation of study activities, as well as interventions and interactions with the study participant
- progress notes
- consultation reports
- diagnostic test results and laboratory results
- dispensing, and if applicable, return of or use of investigational product
- copies of documents from medical records, clinic charts
- Resolve any research study-related issues, problems, concerns and queries in a timely fashion.
- Be prepared for all monitoring visits.
[back to top]
Section 2 - Upon notification of pending audit
- Confirm the date and time for the audit, as well as the anticipated duration of the audit and composition of the audit team. Ascertain whether the audit team will require the use of any specific equipment.
- Notify the principal investigator and research team members of the upcoming audit.
- Ensure that the principal investigator and senior study coordinator are available for the audit.
- Notify the IRB.
- Ensure and confirm that all documentation and records are available for review and are in order. This may include but is not limited to the following documents and documentation: clinic charts, medical records, radiographic images, diaries, questionnaires, and research data records, and study participant files if applicable.
- If your study includes the use of electronically captured data, check with your institution regarding its policy for review of electronically captured data by outside personnel. Be prepared to provide hard copies of the electronically captured data for the auditor’s use.
- Have the Institutional Standard Operating Procedures, and if applicable, your department/division/center’s policies and procedures pertaining to the conduct of research available.
- Meet with the individuals responsible for the receipt, storage, or dispensing of investigational product for the study. Ensure that all of the records are available for review and the storage area is available for review/tour.
[back to top]
Section 3 - In the event of an external audit (sponsor or federal agency)
- Follow the activities listed above under: “Upon notification of pending audit.”
- Consider contacting Quality Improvement to assist in the preparation for the audit.
- Review all of the signed informed consents. Verify dates and signatures in addition to the version of the document that was used. Verify reconsenting occurred when applicable.
- Ensure that all study subjects met inclusion/exclusion criteria.
- Ensure that the sponsor and IRB was contacted regarding protocol deviations and the documentation is available for review.
- Ensure that investigational product was stored and dispensed properly. Records should adequately reflect the quantity received, the date of arrival, the condition of receipt, the serial numbers or other unique identification codes assigned to the product, product was stored accordant to protocol, quantity dispensed, quantity used by the subject and quantity returned to the sponsor/manufacturer or disposed of in an appropriate manner.
- Ensure that logs and tracking records are accurate, complete and available for review.
- Ensure that all case report forms are available and complete, including investigator’s signature and date.
- Ensure that all regulatory documentation and correspondence is present, complete and current.
- In the event a document is missing, request a copy of the document from the IRB.
In the event of a federal agency audit
- Follow all of the activities listed above.
- Notify the sponsor.
- In the event a document is missing, request a copy of the document from the appropriate source such as IRB, CRO, or sponsor.
[back to top]