The Office of Data Quality (ODQ) is responsible for internal auditing of clinical trials per DF/HCC AUD-100. We are thrilled to announce several improvements to the internal audit process rolling out over the next couple of months! A summary is provided below, and more details can be found in the revised Internal Auditing Procedures Manual on the DF/HCC website.
Audit Scheduling Procedures
Identifying appropriate time and (especially) space for internal audits and monitoring visits is an increasingly difficult challenge for the research community. The ODQ is rolling out a more flexible scheduling procedure for DF/HCC internal audits in response to these challenges.
- Initial audit notifications will be distributed earlier (6 weeks in advance) and include a one month window during which the audit will take place.
- The ODQ audit team will request the Overall PI or designee to provide scheduling options during the designated auditing window where the study team and appropriate audit space will be made available.
- Once the audit dates are verified, the ODQ will assign an auditor. Auditors will confirm the audit schedule via email and communicate a list of subject cases (when applicable) at least 2 weeks prior to audit start.
To maintain alignment in our processes with those practiced by the NCI and its agents, ODQ will convert to a new audit rating system for internal audits. Briefly:
Acceptable (No response required)
- No major observations and few, if any, minor observations.
Acceptable, needs follow-up (A formal written response is required)
- Multiple minor observations or any single major observation.
Unacceptable (A formal written response is required)
- Multiple major observations.
In the new system, each audit component (i.e., regulatory, pharmacy, subject cases) will receive a separate rating.
Use of OnCore Auditing Functionality
The ODQ will begin using OnCore to capture and report on internal audit activities. Using OnCore’s built in functionality, we aim to improve the tracking of audit observations, ensure consistency in audit conduct, and streamline issuing final audit reports.
At the outset, the impact of this change on the research community is expected to be minimal. However, investigators and research teams will notice changes to the layout and format of audit reports generated by OnCore.
Once our audit team adjusts to the new system, the ODQ will work with CTRIO to evaluate whether it’s practical to expand the use of Audit functions in OnCore. For example, we’d like to evaluate the feasibility of recording external audits in OnCore and enabling key stakeholders to access audit summary data.
To better support the DF/HCC research community, a cornerstone of ODQ’s mission is the continuous evaluation and improvement of policies and processes. Do you have feedback or suggestions for us? We would love to hear from you!