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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
Event date: 07/10/2020 - 08/10/2020 Export event
Birds-of-a-Feather Webinar: The Use of Audit Trail Review as a Key Tool in Ensuring Data Integrity
Date: NEW DATE: OCT 7 2020 Duration: One hour
Presenters: Linda King, Astellas, eCF Audit Trail Review Team
Miko Pietilä, Signant Health, eCF Audit Trail Review Team
Open To: Staff from eClinical Forum member companies gratis (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 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:
Join us for a discussion of the eCF/SCDM industry position paper on the use of audit trail review as a key tool in ensuring data integrity. We will share our thoughts on the rationale, opportunities and challenges, along with practical implementation recommendations.
Time: This webinar will be offered only once, however a recording will be made for those who cannot join during the live webinar.
For MEMBER registration, please follow this link: https://eclinicalforum.org/Forms/BoF-23-Sep-2020-Audit-Trail-Review ; NON-MEMBERS, please contact us: email@example.com
NOT A MEMBER?
MEMBERS...Recordings Now Available | ICH E6 Guideline for Good Clinical Practice (GPC) – Update on Progress
...public web conference, "ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress," that was held on May 18 & 19 and organized by the International Council for Harmonisation (ICH) and convened by the Clinical Trials Transformation Initiative (CTTI).
...listen to the web conference recordings, view the slides of the full presentations, and watch this video about the ICH guideline development process.
To stay up to date on the work to revise ICH E6, please visit the ICH web page.
VISIT THE ECF MEMBER DISCUSSION ON ICH E6 R3
eCF BoF Round-table: Utilization of Scribes for eCOA
This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing “The utilization of scribes is needed for the conduct of clinical assessments within eCOA. Therefore, eCOA needs to be built in a manner that meets the regulatory requirements for scribing, to ensure all individuals participating in the assessment are audit trailed.”
"When should audit trail begin?"
Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?" It is a discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.
Link to article: When Should the Audit Trail Begin? (appliedclinicaltrialsonline.com)
We welcome feedback! Please send to: REG@eclinicalforum.org
eCF Webinar: FDA OneSource and Common Data Model Harmonization (CDMH)
eCF Webinar: FDA OneSource and Common Data Model Harmonization (CDMH) - Use of Real World Data in Clinical Research
Presenter: Mitra Rocca, FDA CDER Health Information Technology Technical Lead
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 firstname.lastname@example.org )