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eCF Focus Session:  Audit Trail Review in Practice

Wednesday, 18-August-2021

Event date: 18/08/2021 Export event

eCF Focus Session:  Audit Trail Review in Practice

eCF Focus Session:  Audit Trail Review in Practice

Date:  Wednesday, 18-August-2021      Duration: Two hours

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 )

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:  The eClinical Forum published a joint paper with SCDM in April 2021, titled “Audit Trail Review: Key Tool to Ensure Data Integrity”.  (If you missed it, you can download it here: Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0 (eclinicalforum.org) )  Now that members have had time to review the paper and perhaps discuss with colleagues, we thought it is a good time to hear what different members are doing, or are planning to do, regarding audit trail review. This focus session will not be discussing the paper, but rather will be discussing what practices around audit trail review our members are taking.

This is a two-hour focus session. The first hour will be presentations of case-studies, and will also be recorded for those who wish to review at a different time. The second hour will be a round-table discussion and will not be recorded.

First hour: 10-minute case studies

  1. Joint presentation from eCF EDC vendors explaining how to use existing report features in EDC systems to facilitate audit trail review (Alan Yeomans - Neptunas)
  2. ePRO / eCOA case study (Miko Pietila - Signant Health)
  3. Boehringer-Ingelheim case study (Santosh Sankaran, Jun Zhao – Boehringer Ingelheim)
  4. Astellas case study (Linda King - Astellas)
  5. Novo Nordisk case study (Sanna Herrgård – Novo Nordisk)

Second hour:

  • Round Table discussion – Facilitated by Dan Cocozza, Boehringer-Ingelheim. Participants are encouraged to share their experiences, ideas, questions, etc.
  • Next steps (if any) – eCF Facilitator

Time – This is a TWO-HOUR Focus session, starting at UTC 1400. We apologize to those who will be viewing it during a non-optimal time. The first hour will be recorded, however the second hour of round-table discussion not be recorded.

Registration is for eClinical Forum members only: Webinar Registration (eclinicalforum.org)    Non-members can review information about eClinical Forum membership in the membership tab on this website, or contact us at info@eclinicalforum.org. 

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eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.

eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.

We will be discussing a recent eCF/EUCROF positions paper: 

The full history of a clinical trial describes the conduct of the trial and the quality of the data produced. Changes in technology and the evolution of regulatory expectations on electronic systems over the past two decades have resulted in a situation where additional supplementary documentation is needed to reconstruct some clinical trial activities. Many of the computerised systems used during a trial are only used during the active trial data collection stage. This period of use is shorter than the retention period required for the archiving of the essential documents of the trial. Furthermore, the documentation that makes up this history is distributed between sponsor, investigators and vendors. Data is stored locally, in the cloud, on patient devices, at vendors, and sub-vendors. Where the data is archived (sponsor, investigator, vendor), in what format (kept live or static), and for how long are issues discussed in the position paper.  You can download the position paper here: Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1 (eclinicalforum.org)

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eCF Round-table: Electronic Investigator Site Files (eISF)

eCF Round-table: Electronic Investigator Site Files (eISF)

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 challenges Sponsor companies are having evaluating, monitoring and documenting a site’s eISF, and to share best practices, challenges, and ideas. 

Facilitators:   Ronit Elstein (Pfizer, US) Martijn Griep (Janssen, Belgium)

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eCF Round-table: Electronic Investigator Site Files (eISF)

eCF Round-table: Electronic Investigator Site Files (eISF)

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 challenges Sponsor companies are having evaluating, monitoring and documenting a site’s eISF, and to share best practices, challenges, and ideas. 

Facilitators:   Ronit Elstein (Pfizer, US) Martijn Griep (Janssen, Belgium)

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