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Birds-of-a-Feather Round-Table Webinar Discussion: Subject Status Calculations

Date: Tuesday, April 21 2020 Duration: One hour

Event date: 4/21/2020 Export event

Birds-of-a-Feather Round-Table Webinar Discussion:  Subject Status Calculations

;Birds-of-a-Feather Round-Table Discussion:  Subject Status Calculations

Date:  Tuesday, April 21 2020    Duration:  One hour  Time: UTC 1400

Facilitator: Lisa Jones-Moore, Clinical Systems & Supplies Planning, Eli Lilly & Co.

Open To: Staff from eClinical Forum member companies  (If you are not an eCF member, please review the Membership tab of this website for membership information or contact info@eclinicalforum.org )

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:  

This is a round-table discussion and participants are encouraged to share their experiences, ideas and questions on this topic.

The following questions will be discussed:

  • How many subject/patient dispositions do you collect (i.e. Subject completed treatment and follow-up, Subject discontinued treatment and dropped follow-up, Subject discontinued treatment and completed follow-up, etc.)
  • How does subject status get updated in your clinical trial management system?  Automated calculation using a datahub or manual update by monitoring or other personnel?
  • Is monitoring done internally or is there a third party organization performing this task?  If TPO, do they use their own system or your system?  If they use their own system, how does the data get back into your system?

Registration: Please send an email to webmaster3@eclinicalforum.org

 

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

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

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.

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