Lessons Learned Moving Forward – Audit Readiness & Remote Close-Out Visits

September 7, 2021
Denise Beamish
COVID-19 Series, Oncology Trials in Canada, Patient Advocacy

The COVID-19 pandemic has required the clinical research industry to find new and innovative ways to monitor investigative sites. Although the world is making strides towards returning to normal, it will likely be a new normal in which remote activities are more ubiquitous. So, in this new era of remote work, Scimega and our partners at Canadian investigative sites have mobilized to accommodate monitoring off-site.

Throughout, we have continued to ensure compliance during study conduct, with consistent audit readiness that allows for successfully closed investigative sites at a distance. Here are some of our lessons learned for conducting study close out visits remotely.

1. Close-out preparation starts when the site is activated

For any close-out visit, and especially a remote one, the best preparation is to consistently ensure audit readiness throughout a site’s study participation. During monitoring visits, Scimega CRAs continuously validate that all documentation on-site is in order and action items are resolved in a timely manner. These efforts are documented in detailed monitoring reports, that provide a roadmap for everything that has already been verified. Our rigorous pursuit of constant audit readiness also serves us well at the end of the study. If we need to conduct a close out visit remotely, we can rely on the quality monitoring that has taken place from the very beginning of the investigative site’s participation. Ultimately, the remote close out visit is intended simply to tie up a few loose ends, if there are any, and to confirm how study records are to be archived. If we are always audit ready then this becomes the foregone conclusion for every close-out visit conducted.

2. Low CRA turnover boosts confidence and effectiveness with remote COVs

Scimega’s CRA turnover rate is very low. For most projects the CRA who has built a relationship with the investigative site through the course of a study will be the person, one or more years later, who then completes the close-out visit. As a result, the CRA is familiar with the history of the trial at the site, the site’s processes and the way site personnel assigned to the study work best. As such, this CRA is best positioned to conduct an effective remote close-out visit. At Scimega, in the face of COVID-19 our low CRA turnover rate meant the same CRA was the one on-site prior to the COVID-19 pandemic lockdowns, as well as during periods of time when on-site visits were possible. This consistency of our teams’ CRAs, in combination with their long-term experience provides all stakeholders confidence that loose ends have been tied up, and that the study documents are truly ready to be archived following the close-out visit.

3. Coordinators need straightforward tools suited to their needs and ample time to prepare

When close-out visits must be conducted remotely, the study coordinator may be the only person at the investigative site who can verify physical documents and ensure that clinical supplies have been returned to the sponsor. To support completion of these tasks, the CRA prepares tools for the study coordinator well in advance of the remote close out call. The CRA also ensures that the tools provided take-into-account the site’s processes, the study coordinator’s level of experience and availability, and the number of items that need to be validated for close-out. A CRA who has been with the study from the beginning, and who has rigorously implemented audit ready processes throughout the course of the study knows the study coordinator and investigative site and team well; and can readily identify the appropriate amount of support the coordinator needs to best help her prepare in advance of close-out.

4. Agility, communication and teamwork with site personnel are key

Some sites have electronic records, while others may continue to have some paper records. An important part of study monitoring in general, and including remote monitoring, is to be solutions-focused and collaborate as an engaged team player with investigative sites. Wherever possible leveraging available technology to streamline, simplify, facilitate audit readiness, and to not only review documentation but also monitor clinical supplies like drug inventory is du rigor. At Scimega, we have strong, collaborative relationships with investigative sites. We nurture these relationships by communicating respectfully and effectively with site teams, which facilitates exploration of options, and working together to find creative solutions that best serve both the patients involved and the study underway.

5. Putting people first is golden

This pandemic shocked the world, the clinical trial industry and the people that move this industry forward. Throughout, Scimega CRAs and country leads have kept participant safety at the forefront, viewing new challenges as opportunities to support site personnel as they continue to safely offer clinical trials to their cancer patients.

As the site personnel’s primary point of contact with the Sponsor, CRAs are positioned to best represent the values of the clinical trial team to sites and study participants. When site personnel are advocating on behalf of a patient’s questions or concerns, the CRA is an ally who conveys these concerns to the country lead for further discussion with the clinical trial team. With the experience of the pandemic, for many of us, key among the lessons learned includes the ever more apparent importance of putting people first.

6. Choose the right partner for your study in Canada

At Scimega, we are proud to say that the sites and Canadian PIs we work with are often top enrollers in the global oncology studies on which we collaborate with sponsors. This fact is one that many of our sponsor particularly appreciated during the restrictions of the pandemic that considerably slowed enrollment in other regions.

As a niche Canadian CRO skilled in collaborative vendor teaming with a proven track record of 24 years unparalleled Canadian oncology experience Scimega guarantees sponsors the quickest site start-up and highest patient recruitment rate, without sacrificing premium quality data. With an optimal operations design robust enough to address an ever-changing clinical trial landscape, Scimega’s team of oncology experts go above-and-beyond for your study to provide:

Identification and qualification of the right Canadian sites for your trial within just a few weeks thanks to our extensive network of Canadian Investigators.