Protocol Deviations Management Toolkit: Seeking Public Feedback
The lack of clarity regarding the definition of “important” protocol deviations (PD) has led to both over and under interpretation of deviations. This impacts the planning, collection, analysis and reporting of important protocol deviations. This also has the potential to increase noise in the PD management process whereby hindering the identification of important patient safety information and influencing the reliability of trial results and human subject protection.
With feedback from the FDA, this TransCelerate initiative created a Protocol Deviations Management Toolkit to help clarify the definition and process for identifying “important” PD.
- The draft toolkit will be made available on the TransCelerate website on or around 19Aug2019, and registered participants will receive an announcement when the draft toolkit is available.
- The Toolkit will undergo public comment through 11November2019.
Two identical free webinars are offered to educate industry on the work done by this initiative, and invite participants to review and comment on the draft toolkit:
- Session 1: Tuesday 22Oct2019, 9am-10am (eastern timezone) (click the blue button below to register for this session)
- Session 2: Wednesday 23Oct2019 8pm-9pm (eastern) (click here to register for Session #2)
Participants will understand how the proposed framework and tools can be leveraged to identify “important” protocol deviations and increase process efficiencies for Sites and Sponsors.
- Anyone involved in managing protocol deviations from the sponsor, site or CRO perspective.
October 22nd 2019 from 09:00 AM to 10:00 AM