"This is the best use of my time to remain current with what is going on in the industry."
WHO WE ARE
The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), PR2.1”.
About the Best Practice Document: There is increased scrutiny by regulatory agencies on the collection of investigator’s signatures as evidence of the overall oversight on the eCRF is reported to the sponsor. eClinical Forum PI Signature Working Group was formed in March 2021 to update the best practice document originally issued in 2017 by identifying best practices that are based on compliance with regulatory requirements and on risks such as reputation, credibility, and legal liability of the data being used by the sponsor.
Building upon the relevant requirements regarding the investigator’s signature from the current global regulations and guidelines, it proposes the risk-based approach to the collection and control of the investigator’s signature on the eCRF data. EDC functionalities are also recommended to better facilitate the collection and the monitoring of the investigator’s signature. During the project, EMA issued the draft guidance titled “Guideline on computerised systems and electronic data in clinical trials” and the Working Group used this as an input in a timely manner.
This is a significant accomplishment by the PI Signature Working Group who shared their experiences and insights which were crystalized as the best practice document. We’d like to thank co-chairs Cinzia Piccini (Eli Lilly) and Babette von Hagen (CSL Behring), and each member of the Working Group for their invaluable contribution to the development of this document.
This release is the public release, following the member release in April.
NOT A MEMBER?
eCF Webinar: Artificial intelligence can improve patients’ experience in decentralized clinical trials
The clinical trial industry is undergoing a rapid transition toward decentralization, where some or all health assessments are performed remotely in participants’ homes instead of in medical centers. Adopting artificial intelligence in this setting can empower more patients to enroll in trials, successfully complete them without burden, and submit high-fidelity assessments of their health. In this talk, the presenters will discuss insights from their recent article in Nature Medicine on this topic. The article can be viewed at: Artificial intelligence can improve patients’ experience in decentralized clinical trials | Nature Medicine
(23/03/2023)
eCF Technology Showcase: BSI Life Sciences - "Onboarding a combined CTMS and eTMF”
The digitalization of clinical trials and operations has been at the forefront of pharmaceutical and med-tech modernization strategies over the last two decades. However, many companies are still struggling to digitize their clinical operations for various reasons: old habits, fear of adopting and rolling out an electronic solution, potential delays on deadlines, or concerns about quality and compliance. eCF Member BSI will share their thoughts on why a unified CTMS and eTMF is crucial in running clinical trials in the age of digitization and technology, while providing examples with their CTMS and eTMF.
eClinical Forum In-Person and Remote Workshop, Blue Bell, PA
We are pleased to announce our next Americas Workshop in Blue Bell, PA USA on May 15-17 kindly hosted by Signant Health.
This workshop will be available for face-to-face and remote participation.
We hope you can join us!
REGISTRATION IS OPEN: eClinical Forum Hybrid Workshop, Darmstadt, Germany June 14-16, 2023
We are pleased to announce that registration is now open for our next European Workshop in Darmstadt Germany on June 14-16 hosted by eClinical Forum.
This hybrid workshop is available for face-to-face or remote participation.
READ MORE to download Agenda
REGISTER NOW