May 11 2022
Written by Mary Jo Antonelli, MBA, MHA, Director of Quality Assurance and Operational Support for NRG Oncology
The Remote Audit
The COVID-19 pandemic introduced the remote audit to the overall NCI audit landscape. With an ever changing and unpredictable evolution, COVID-19 continues to drive the need for remote auditing. However, the pandemic has also given us the opportunity to learn how remote auditing can be an efficient and effective way to perform audits in certain circumstances. In some cases, the remote audit approach might be the best practice. Moving forward, remote audits will continue to be conducted. The following hints and tips will help support the remote process and ensure operational success of the audit.
In advance of the audit consider the following:
- Review the September 2021 NCI Audit Guidelines, Section 2.4.2, Auditing Patient Cases Utilizing the Source Document Portal (SDP) and Section 4.3, Off-site/Remote Audit prior to the scheduled audit.
- If EMR access will be provided for the patient case component, ensure access is established in advance and local support is available for initial account set-up to prevent delays in the start of the audit.
- Auditors should not be asked to provide Personally Identifiable Information (PII) per NRG Oncology and the CTMB. Please refer to Section 4.3 of the September 2021 NCI Audit Guidelines. https://ctep.cancer.gov/branches/ctmb/clinicaltrials/docs/ctmb_audit_guidelines.pdf
- Guidance documents on where to find records within the EMR system are helpful for the audit team.
- Know your organizational requirements and the time it takes to establish external EMR access for all sites involved in the audit.
- Provide confidentiality agreements in advance; some documents require additional review.
- Provide local IT support for initial account access. Recommend having an IT staff support person available on the morning of the audit for troubleshooting any IT issues.
- Identify staff who will support audit team and the primary method of communication (via email, phone, video meetings).
- Organize site specific schedules with audit team.
- Determine if remote (video) pharmacy inspection is possible and schedule in advance of the audit start date.
- Be available, check in with audit staff, remote audits require more frequent email monitoring.
- Determine Exit Interview attendees in advance to ensure availability for key personnel and work with the NRG Lead Auditor to establish the day and time of the meeting.
- If EMR access is not possible, redacted patient case documents may be provided using a shared portal (e.g. Box, SharePoint) or by uploading redacted patient case documents to the CTSU audit portal. https://www.ctsu.org/master/simplepage.aspx?ckey=HELP-CM
- If utilizing a shared document portal, organize, when possible, by protocol timeline/schedule of events not by document type. File naming conventions that follow the protocol and EDC (RAVE) structure are helpful when possible.
- Regulatory and Pharmacy components of the audit continue to be reviewed off-site by NRG Oncology QA staff. This process is unchanged and will remain in place regardless of the location of the patient case component of the audit.
- However, for pharmacy review of security, storage and shelf counts determine in advance of the audit if inspection may be done via a scheduled video call (e.g., FaceTime) with the audit team.
Communication is key:
Audit is a part of the quality assurance activities to promote conducting quality research. This requires that both the audit and the clinical team share goals, good communication, and value the audit process as a learning experience.
Sharing source documents when EMR access is not possible:
Reminder about Regulatory and Pharmacy audit component review:
Reminder - no unannounced cases will be part of a remote audit.
On-Site Audits and General Preparedness
As conditions permit, on-site audits will be presented as an option during the audit scheduling process. The safety of all involved is the priority for considering returning to an in-person audit. Institution requirements, restrictions, as well as audit team travel considerations are key factors in determining if an on-site audit is possible. When an on-site audit is determined, the following guidance should be considered.
- Ensure COVID-19 accommodations are possible with adequate workspace.
- Wi-Fi access is needed for auditors to audit directly in Medidata RAVE.
- Notify NRG in advance if electronic records will be accessed while on-site.
- One computer per auditor (site supplied) is required for EMR access and an adequate work area is appreciated – auditors will be using two computers and need space to write.
- Allow time for an EMR access test run to make sure that all computers work and that the auditors can access all needed systems and records.
- Have tech staff available to troubleshoot access issues.
- Allow extra time for auditors to become familiar with systems (a flow diagram of where to find records is helpful).
- Auditors may need more frequent assistance from staff until familiar with programs.
Best Practice – General Tips
- For ongoing successful protocol implementation and conduct, be familiar with entry requirements, the timing of assessments, specimen requirements, PRO collection and establish internal best practices.
- Evaluate data reporting on an ongoing basis to ensure complete and timely data reporting.
- Utilize NRG Oncology Performance Reports as an additional resource to address data delinquency and query management.
- Contact NRG Oncology with questions regarding study management.
- Conduct internal audits.
- Provide auditors with directions/instructions for building location, access, contact information, ahead of their travel.
- Create a list of your staff’s credentials prior to the audit and communicate to the lead auditor who attended the exit interview.