A Guide to Remote Audits of Research Studies
Not every due diligence audit needs to be face-to-face
One facet that has remained constant throughout the history of the regulated science industry is the need to actively assure work is being done to solid standards and applicable regulations for contracted and outsourced work. With Covid-19-related restrictions mandated across the world, a method to continue this monitoring needed to be developed. As remote audits become more prevalent, there is good reason to keep using the approach even beyond the pandemic.
The labor and travel expense can be a significant chunk of the budget when conducting on-site audits. Consultant fees from additional outsourcing for sufficient oversight can be costly. Limitations to travel may make it difficult to complete on-site audits or may be conducted in a narrow time frame due to resource availability and travel requirements. Virtual audits allows for auditing at your leisure and your location of choice. Technology advancement and solid processes do allow for effective remote audits now and in the future.
Here are six areas to consider when going the virtual route.
- Establishing the dates and duration of the audit. Remote auditing may be the new normal, but it is surprisingly as easy to schedule one as an onsite audit! Just contact the representative at the site you are interested in auditing and let them know you would like to conduct a remote audit similar to planning an on-site visit. The audit host will coordinate with you to identify common dates that are convenient for both parties.
- Preliminary activities in advance of the audit dates for auditor. A detailed agenda will need to be made available and shared between the parties. This helps to ensure the audit objectives are known and able to be met. Also, coordinating to ensure a secure platform is easily accessible to support the remote audit is key to success. Accessing the platform may need IT or additional support due to system security settings and other logistics. Testing in advance establishes smooth process for a successful remote audit.
- Preliminary activities in advance of the audit dates for the host. Once dates and the information sharing platform is established, the host will begin to make available the supporting audit documents, post content, to support the audit, just as would be available for an on-site audit. In addition, the host will secure availability of the staff needed to support any interviews or questions to be conducted during the audit.
- Ease of access to records during the audit. Once the requested records are available, reviewing documents can commence without the need for continuous host oversight. Using email, phone, or other technology like Skype and Teams chat features, the auditor and host can maintain necessary communication with relative ease. If there are specific requests for additional information, the host will gather those materials and make them available.
- Conducting virtual inspections or tours. Similarly to an on-site audit, a facility tour or study specific monitoring can be scheduled with the use of video sessions. In addition, demonstrations of computerized data collection systems can occur via screen sharing sessions.
- Audit conclusion. As with an on-site audit, the remote audit should close with a meeting inclusive of Test Facility and QA management This allows for sharing of positive experiences and procedures as well as discussion for areas improvements are recommended.
During the pandemic routine re-qualification, data reviews, scientific and inspectional oversight audits continue to occur. While virtual audits may be a newer concept to the regulated science industry due diligence audits, they do provide for an effective audit approach as well as flexibility and cost savings. In short, the pandemic has provided a new solution that is as effective as an on-site visit.
(Charles River, a leading contract research organization, has innovative and secure capabilities to share information. It currently offers a full range of virtual platforms to enable sponsors to conduct remote audits)