With unplanned inspections by regulators becoming increasingly common, ensuring that trial documents and data are in order and quickly accessible across all your clinical sites is a must.
In 2016, the ICH published an addendum to its GCP guidelines, which placed more emphasis on the use of real data and insight to manage and design trials, and encourage greater use of technology.
This means that, in addition to ensuring that documents are accessible, the way in which they are stored and managed is also now under scrutiny during an inspection.
The GCP guidelines outline certain requirements for the management of documents and also for the validation of technology systems used. They also place more onus on how risk-based trial management is recorded.
With all these factors to consider across multiple sites and investigators, how can you guarantee that your sites are inspection-ready?
Is your trial documentation all in one place?
It may sound obvious, but the key to a worry-free inspection lies in ensuring that all your trial information is easily accessible to the inspectors when the time comes.
For a sponsor, this includes key documents such as the protocol and its amendments, but also extends to technical information, communications to investigators, safety reports, training records, checklists, consent forms, and monitoring templates.
Inspectors will also expect ready access to electronic versions of essential documents, and may wish to review metadata associated with the files in order to see when documents have been amended and whether any changes have been made.
A centralized repository to host this information in one place, with version control management and the ability to generate bespoke reports, can make this aspect of inspection preparation a cinch.
Are you tracking everything you need to?
With the move towards risk-based management, collection of information is critical, but it’s just as important to demonstrate trace-ability when it comes to decision-making: that you have captured, audited, and archived the key information that was collected; the communications that followed; how those decisions were made; and what actions were taken.
One of the core requirements of any electronic system within GCP is that it includes audit trail functionality. A system - used by sponsors, CROs, and sites alike to share data and to communicate - that can record when a communication has been read or a task completed, facilitates effortless data-tracking when it comes to inspection time.
Can you show quality management of your trial?
Training and SOPs are recognized by the ICH as fundamental elements of a quality management system. There is, however, little point in investing in the best training materials, and putting multiple SOPs in place, if there’s no evidence to support your site teams using them.
Documented evidence of on-boarding the study team and providing training are requirements in the latest GCP guidance. An audit trail to show that information has been received and training has taken place is equally as important as the preparation of these resources in the first place.
Keeping a track record that shows in real-time when training has been completed, and whether protocol amendments or safety alerts have been read and understood, will go a long way to offering assurance with respect to the quality management of your trial.
Recording this in one place not only makes it straightforward for you, but inspectors can quickly identify that your sites have been fully on-boarded, and that everyone is following the trial protocol and its supporting documentation.
Facilitate straightforward, streamlined inspections, both for the regulator and for yourself:
- Store all trial documentation in a single, centralized repository for easy access
- Track all communications and decisions made
- Maintain comprehensive training records to support excellence in site on-boarding