October 12 2021
Written by:Eric Wiedenfeld, MBA, Research Coordinator III, and Kate McCaffrey, B.S., MBA, Clinical Research Administrator - Taussig Cancer Institute, Cleveland Clinic
Yes, even in a pandemic, clinical trials and the sites that run them still need to be reviewed for compliance and integrity. These reviews come in the form of single study and site audits. Our center’s planned triennial NRG audit was postponed in 2020 due to the ever- changing and unpredictable nature of the COVID-19 pandemic. Over a full year later, we were finally able to have the reschedule of that audit.
Unfortunately, some of the same challenges from 2020 have carried into 2021, but as a site and clinical research department we are now better prepared to handle the circumstances created by the pandemic. For starters, we have evolved our monitoring policy and are currently working only with remote monitoring visits and audits. This is in large part due to the restrictions on visitors in the clinical setting and for the safety of our employees who are better able to social distance with fewer people in the office.
One of the ways we have been successful in remote reviews is by offering access to select electronic source documents through a portal. Of course, this is with signed ICFs and contracts in place. Our portal system is called DrConnect and it provides users a read-only view of a specific research patient’s records. We give the auditor access during review and then when they are done, we revoke that access. Getting access for auditors allowed patient binders to stay safe on their shelves, decreasing the risk that comes with emailing or snail mailing these documents. It also allowed the auditors to see everything without fumbling through mountains of source. With the exception of any wet-ink or paper source not saved in the Electronic Medical Record, all research source for the selected patient is readily available through the portal.
Another institution has suggested a couple other ways to bridge the connection between sites and auditors in this remote setting. When the auditor is looking at eligibility, it is helpful for them to see an “outline” that shows each eligibility item and where verification of it can be found. An example of this would be: “Inclusion 3.1.1 – page 12 of MRI report”. In addition, they have stressed that the naming convention of documents is extremely important. Naming the documents consistently and in numerical order helps to direct reviewers to where they need to look. An example of this would be “01.Sitenumber.study#.PID.document type” – this is so the site can direct the auditor to “document #1, page 3”, for example.
With that said, remote audits while efficient and convenient still lack some things. The personal connection and relationship built between external reviewers and research team members can take extra effort on both sides when only communicating remotely. Emails, instant messaging, and phone calls can leave things unsaid or misinterpreted, especially in a high stress situation like an audit.
Removing the stress factor of the audit and assuming your site is perfectly prepared, there is still a lot of information to be conveyed and questions back and forth. Electronic communication can be a slippery slope of miscommunication if you are not careful. This can lead to additional time spent on a single item, just to get the two sides on the same page. When able to, we recommend a phone call or daily wrap up meeting to help close the gap on any lingering questions.
As a whole, remote audits keep everyone much safer: the patients and their health information, the auditors, and the sites getting audited. The biggest drawback is simply that we are all still adjusting to this new world of clinical research and technology still has not quite reached the point that it can replace a discussion across a table – even if both people have masks on and are six feet apart.
NRG Oncology QA Remote Audit Guidance