Phlexglobal Issues Industry Advisory on New EMA Guidance
Phlexglobal announced an important industry advisory around the new European Medicines Agency (EMA) guidance on Trial Master Files. The guidance took effect on June 6, 2019.
At 17 pages and going into specific detail, the new TMF guidance holds many potential pitfalls for companies, including:
- Reinforces that from a regulatory perspective, the responsibility for an outsourced Trial Master File lies with the sponsor, and lays out numerous areas sponsors need to address – from the structure and indexing of the TMF to the details of eTMF system and change control management.
- Details updated technology requirements for electronic TMF systems, including audit trails, access controls, backup, and archiving – and when other systems must also meet these requirements.
- Explains why chapter 8 of GCP is not a definitive list of what should be in the Trial Master File – and the best place to get your checklist.
“Over the past 12-18 months, regulatory agencies have been increasing their focus around the Trial Master File and tightening their enforcement,” noted John McNeill CEO of Phlexglobal. “Where once inspectors might have let things go with a warning, today the consequences of poor TMF management include study delays or halts, as well as financial penalties. As a result, companies can no longer simply treat the Trial Master File as an afterthought.”
One reason for this increased stringency around the Trial Master File is a recognition among regulators that the TMF is an indicator for the study itself. This is spelled out clearly in the very first section of the guidance:
“Trial master file (TMF) plays a key role in the successful management of a trial by the investigator / institutions and sponsors. The essential documents and data records stored in the TMF enable the operational staff as well as monitors, auditors and inspectors to evaluate compliance with the protocol, the trial’s safe conduct and the quality of the data obtained.”
More information can be found at http://www.phlexglobal.com
FDA Finalizes Decentralized Clinical Trial Guidance
November 25th 2024The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Patient Engagement Platform Checklist
November 22nd 2024Modern clinical trials are more complex than ever, and one significant reason is the increased focus on patient engagement. Incorporating a patient engagement platform into your clinical trial enhances the patient experience and can lead to more successful trials with stronger, more reliable outcomes. We put together this helpful checklist of key features to look out for when choosing a platform for your study.
The Rise of Predictive Engagement Tools in Clinical Trials
November 22nd 2024Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.
