Contract research organizations (CROs) and sponsors can up each other’s game with vibrant, transparent, and two-way inspection programs bolstered by the latest technology, several experts report.
“When sponsors know they can audit us remotely, it keeps you on your toes in a good way,” says Hunter Walker, chief technology officer for the Atlantic Research Group (ARG), a small CRO based in Charlottesville, Va.
At the heart of any effective inspection program is a robust electronic trial master file (eTMF), says Jim Reilly, leader of the clinical strategy team at Veeva. “You don’t look at the eTMF as a graveyard [or] repository, but rather you look at it as that place where I tell the story of the trial,” Reilly says.
Handling the eTMF properly is key, Walker agrees. Otherwise, a CRO can fall into bad habits. “[The attitude can be] ‘Oh, the eTMF is in this paper box, and we’ll get it sorted out when the inspectors arrive,’” Walker says. “Not that ARG has ever done that, but I’ve heard of some CROs [that have] now and then.”
Get TMF Tips at ACRP 2019
The key to a successful inspection is preparing at the start of the study. Ensuring that your Investigator Site File and Trial Master File are built in a way that the complete documentation tells the story of the study will ensure you’re prepared come inspection day. Join us in Nashville April 12-15 and learn more tips for inspection prep – including common GCP violations that are evident in the TMF/ISF and can result in findings – from industry expert Donna Dorozinksy, RN, MSN, CCRC, Senior Trainer, Barnett International.
More and more CROs are using eTMF as a strategic asset, according the Reilly. It can be used to collect “both the operational information about an event, but also the content that tells a story as that event is unfolding,” he says. “That’s what true inspection readiness is.”
“It’s actually cut down on travel time as well,” Walker adds. One way this happens is from sponsors being able to eliminate some travel because they can conduct audits remotely.
“It drives higher quality and better outcomes when you manage an eTMF” proactively, Reilly says.
Author: Michael Causey