Medical College of Wisconsin
Medical College of Wisconsin Medical College of Wisconsin
Research Microscope Lab
Human Research Protection Program

MCW HRPP Audit Preparation, Participation and Follow-up

Human subject research projects may be audited as a surveillance activity or for-cause by Sponsors, Regulatory Authorities or by the Institution including the IRB.

Audit Preparation Participation and Follow-up 

Human subject research projects may be audited as a surveillance activity or for-cause. Preparation for an audit may begin at the time of initial IRB approval or upon notification of an upcoming audit activity. Corporate Compliance Policy requires the research team to notify the IRB of external party audits at the earliest opportunity.
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Audit preparation
  • Preparation for an audit can begin 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 research conducted in your department, organization.
  • Know and observe your department/division/center policies and procedures for research-related activities.
  • Know the research-related roles and responsibilities of the principal investigator and other research team members.
  • Differentiate between the research-related and clinical 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 of the budget.
  • Create tools for documenting research activities (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 research project 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 inclusion criteria and none of the exclusion 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 reflect and represent the conduct of study activities and recorded research data.
    • Develop and implement a system for organization of documents found in the investigator’s study regulatory file to facilitate a complete and organized file.
    • Develop and implement a system for organization of documents found in study participant file to facilitate complete and organized study participant files and provide a central location for 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, if applicable
      • 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


Upon notification of a 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: the study regulatory file, clinic charts, medical records, radiographic images, diaries, questionnaires, and research data collection 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.

In the event of an external party audit
  • Follow the activities listed in “Upon notification of pending audit.”
  • Consider contacting the HRPP Quality Improvement staff to assist in the preparation for the audit.
  • Review all of the signed informed consents. Verify dates and signatures are documented and the current version of the document was used in the consenting process. Verify reconsenting occurred when applicable. Verify all signed consent forms are available for review.
  • Review documentation to ensure that all study subjects met eligibility criteria and study related activities were conducted in accordance with the IRB approved protocol.
  • Review documentation to ensure that the sponsor and IRB were contacted regarding protocol deviations and the documentation is available for review.
  • Review documentation to 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.
  • Review documentation to ensure that logs and tracking records are accurate, complete and available for review.
  • Review documentation to ensure that all case report forms are available and complete, including investigator’s signature and date.
  • Review documentation to 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 appropriate source such as IRB, CRO, or Sponsor.
  • In the event of a federal agency audit
    • Follow all of the activities listed above.
    • Notify the IRB.
    • Notify the Sponsor.

During the audit
  • Verify credentials of auditor.
  • If federal audit, request to see “notice to inspect."
  • For federal or sponsor led audits invite the HRPP Director or Quality Improvement Manager to attend the opening meeting.
  • Provide adequate space for auditor(s) to conduct inspection.
  • Ensure the availability of equipment requested by auditor, if applicable.
  • Identify the key point person and ensure that the key point person is available during the audit to address the auditor’s question/concern or find requested documentation.
  • Answer all questions honestly. If you do not know, don’t guess, indicate you will find the answer and provide the information to the auditor.
  • Supply all requested materials. Do not allow auditor to retrieve documents/materials.
  • Make copies of documents as requested by auditor. Make a second copy for your record of items provided to the auditor.
  • Have Institutional Standard Operating Procedures and, if applicable, Department/Division/Center policies and procedures available.
  • Do not volunteer information.
  • Do not offer anything of significant value to the auditor.

Upon completion of onsite audit activities
  • Attend debriefing meeting with auditor(s) for summary and discussion of audit findings and identify what subsequent activities may be expected.
  • Attendees of debriefing meeting should minimally include principal investigator and senior study coordinator/research nurse manager from the research team and the HRPP Director or Quality Improvement Manager.
  • Review audit findings during the debriefing meeting. In the event a documented deficiency was corrected during the audit, review your concern with the auditor and request deletion of the deficiency from the report.
  • Provide information to the IRB regarding the audit with the next progress report.
  • If corrective actions are requested:
    • Research team to begin identification and implementation of corrective actions in response to audit findings.
    • Research team to prepare written response regarding audit findings.
    • In accordance with Corporate Compliance Policy (network access required), provide drafted response to the Senior Associate Dean for Research for review prior to submitting final response to auditor.