Birds-of-a-Feather Discussion: Industry Adoption of RBM after ICH-E6(R2)
Date: Wed, Nov 7 2018 at UTC 07:00 -- Presenter Abby Abraham, OmniComm Systems
Wed, Nov 17 2018 at UTC 16:00 – Presenter Ken Light, OmniComm Systems
Duration: one hour
Open To: Staff from eClinical Forum member companies (If you are not an eCF member, please review our website www.eclinicalforum.org for membership information or contact firstname.lastname@example.org )
Background: eClinical Forum Birds-of-a-Feather sessions focus on the details of a specific topic. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.
For This Topic:
Risk-based approaches to monitoring (RBM) is becoming widely accepted in the clinical trials industry. Important amendments to ICH-E6 (R2) guidelines from 10 February 2017 and the adoption of the same by regulatory agencies make implementation of RBM and ICH-E6(R2) imperative for organizations. Hence, an understanding of how organizations (by type, size and geographies) are approaching the implementation of RBM is important to set the course of implementation within organizations. The eClinical Forum survey in partnership with OmniComm Systems has gathered insights pertaining to current state of RBM as well as desired state of implementing RBM and compliance to ICH-E6(R2) from a process and technology perspective. In this BoF session, the results of the survey will be presented to the members. We believe that the findings of this survey will help organizations to reflect, strategize and design their implementation approach.