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Hot Topic Discussions

Hot Topics from ACDM

About ACDM Hot Topics

These are held online as ‘discussions’ focussing on a topic in Data Management. They are free for ACDM members (small fee for Non-Members).

As they are ‘discussions’ they are different to webinars and no presentation slides are prepared.

A person is identified to lead each session, together with a Chair, they drive the discussion with those who join call. Sometimes the sessions are recorded and/or summarised and shared with ACDM members.

Increased variability in eCOA data collection methods during COVID-19: impact on Data Management

Date: April 30, 2021
Type: Hot Topic
Session Lead: Chris Barden, Kayentis
Location: Online 12:00 – 13:00 UK Time
Learning Objectives:

Over the last year many trials have had to pivot to alternative data entry modes for Clinical outcome assessments (COA) when trial participants could not attend sites visits.

Data management teams now must maintain and manage data quality and integrity with an increased level of variability from multiple sources of data acquisition.

Amongst many, the FDA , EMA, MHRA, PDMA released guidance papers on running trials during COVID-19, with the FDA specifically highlighting factors to consider when switching to remote clinical outcome assessments.

The C-Path PRO & ePRO consortium then provided a best practice guide on COA risk assessment and mitigation strategies.

These guidance and mitigation papers lead to a larger debate around the new eCOA normal and the impact to data management post COVID-19.

So what is the impact to data management activities and associated risk management If a patient is unable attend a planned site based visit? Or if home data collection becomes the new normal?

  • Is there a preferred alternative to site data collection?
    • Phone Interview, Video Interview , patient direct entry via web, BYOD or IVRS ,switch to paper back up, visiting a patient home.
  • Which modality has biggest impact on data management
    • Will the data entry need to be SDV ?
    • How do we manage audit trails ?
  • What is the regulatory risk with each mitigation strategy?
  • Can you mix modes of eCOA data entry to give patient a choice of preferred option?

This hot topic discussion is designed for attendees to share experience in switching to alternative eCOA modalities and what we can learn and take forward into new study designs in the future.

Who is this suitable for?

ACDM members and non-members who would like to join an open discussion concerning a Hot Topic in Data Management

Outline content
Price (Member)  £0 (+VAT)
Price (Non-Member)  £50 (+VAT)
Link for Booking:

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