Trial360 new enhanced PI - QA - Data entry Oversight Feature
The new and improved quality review functionality within Trial360 seamlessly integrates quality assessments directly into the visit process. Effortlessly capture review details, including date, time, reviewer name and role, responsible party, a description field, and the option to link findings and deviations to the corresponding record.
Conveniently monitor the review status through the upper bar, where “to do,” “pending,” or “ended” indicators provide a clear overview.
Why this feature is important
ICH Annex GCP E6 (R2) mandates that the principal investigator (PI) actively oversees clinical trials. Sites must demonstrate the PI’s active participation and fulfillment of required responsibilities. The delegation record is not merely a formality; the PI must be prepared to substantiate their actions if requested.
In a clinical trial, the sponsor assumes overall responsibility for the quality management of the trial, even if it delegates some or all of its responsibilities to a Contract Research Organization (CRO). The same applies at the Research Site level. During the execution of the study, the Principal Investigator (PI), assumes overall responsibility for the medical care of the participants and the conduct of the trial, even if he/she has delegated some/all tasks to the on-site team. To this end, they must ensure that they maintain oversight of their judgment.