Birds-of-a-Feather Round Table Discussion:  New recommendations from EMA on the frequency of investigators’ signature collection on eCRF data

Date:  Tuesday 26-January-2020   Duration: One hour

Presenters:   Cinzia Piccini  (Eli Lilly) and Babette von Hagen (CSL Behring)

Open To: Staff from eClinical Forum member companies gratis  (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org ).  If you are an eCF member, please send a note to survey@eclinicalforum.org for registration information.

Background: eClinical Forum webinar 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:   In July 2020, EMA released a new Q&A to provide further expectations on continuous oversight and frequency of investigators’ signature collection on eCRF data reported to the sponsor. Prior to filing a marketing authorization application, all eCRF data should be signed and dated. But also important data such as that related to reporting of SAEs, adjudication of important events and endpoint data, DSMB review, should be signed off in a timely manner. In addition, a timely review and sign-off of data that are entered directly into the CRF as source is particularly important.

The intent of this webinar is to identify if there are new challenges, and if any – to proceed with an update to the eCF best practices on investigator signatures document that was released in 2017.

Ref.: Q&A: Good clinical practice (GCP) | European Medicines Agency (europa.eu)

Time – this webinar is offered at 2 times, both on Tuesday 26-Jan-2020.  Webinar A is at UTC 08:00 and Webinar B is at UTC 16:00.  We hope you will find one of them convenient for your participation.