March 4, 2019
Multi-site trials rely on experienced remote monitors to coordinate their activities and communications, but that doesn’t mean the individual sites can slack off. The absence of face-to-face communication can magnify seemingly simple errors, a veteran trial monitor warns.
Barbara Winter, an independent consultant and remote monitor based in Sacramento, Calif., urges sites to improve their internal communications and training strategies if they don’t have a dedicated monitor on-site to keep a careful eye on things.
Winter, a veteran with more than 33 years of experience, knows of what she speaks. She’s a remote monitor for an ongoing, 13-site trial of a vaccine for children and adults who’ve received bone marrow transplants. One of the sites, at “a prominent research institution” Winter declines to name, has just had to suspend operations so that she can root out problems with the site’s delegation-of-authority logs.
What she discovered, reviewing the scanned, online documents, is that the site appeared to be allowing an unapproved employee to take patients through the informed consent process. The employee wasn’t listed in the site’s delegation-of-authority log but was still performing an essential function.
A delegation-of-authority log is not specifically required by FDA regulations, but is a commonly used method of keeping track of staff responsibilities, assignments and qualifications. Delegating authority for essential tasks to staff without appropriate qualifications is a potential federal violation and breach of the trial’s data integrity. FDA data reviewers and inspection teams peruse such documentation very carefully, and any slipup could mean rejection of a new drug application on the basis of suspect data or a warning letter from the agency citing failure to follow good clinical practices.
Sharing data and documentation online is no excuse for experienced trial staff making such errors, Winter says. “They should be paying attention to the same details whether it’s remote or whether it’s on-site.”
The difficulty is that mistakes can be compounded when the monitor isn’t on-site to help catch those problems and rectify them quickly, she says.
“If I was on-site, it wouldn’t have blown up into an issue. Whereas, now we’re going through this back and forth,” she says. “It’s becoming a big whoop-di-doo, and I’m being sent out for a rare on-site visit. I’m having everybody at this site retrain on how to complete regulatory documents.” All of this adds to a trial timeline that already is tight.
Winter admits her own Luddism — ”I’m from the old generation where you pick up the telephone. Now people text, and I’m not into texting” — but the fact is that seemingly simple paperwork errors can gum the works quickly no matter how well technology facilitates communication, she says.
“It takes time for me to write a query, it takes time for them to answer the query. It’s the query process that’s expensive,” she says.
All is not lost, though, Winter adds. Sites can make their lives easier by focusing on a top-to-bottom, bottom-to-top training regime, where everyone involved in a trial understands every piece of paper involved.
“They need to know the purpose and the design of each form that’s being requested. ‘Why are we being asked to fill out a Form 1572 [Statement of Investigator]?’ Well, it’s a contract between the site and the FDA” that is required by regulation, she says. It’s a commitment that a trial will be conducted in a specific way.
Similarly, sites should focus on that same vertical and horizontal communication (yes, even email) to keep the entire team informed about staff changes.
“The PI has the oversight, but if the PI doesn’t know that so-and-so has been promoted to coordinator,” that communication channel has been blocked, she says
-By Bill Myers