Data Management Expert Groups (DMEGs)
Aim
To provide a key benefit to ACDM membership of a new forum for Subject Matter Experts across Clinical Research to discuss topics, develop best practice and lead the way forward in their field of expertise.
Objectives
On behalf of the ACDM:
- to create useful resources (articles, white papers, best practice, guidelines, etc.) for the ACDM membership to utilise
- to aid in the creation of training activities
- to manage, run and participate in ACDM Hot Topics of special interest
- to aim to partake in conference and help encourage attendance
- keep members informed by helping to regularly communicate/blog updates to increase member engagement
Approach:
There should be one or more individuals leading & driving the group forward and doing so in a non-biased way, ensuring that there is always a successor to maintain the group, feeding information/updates to the board of intentions and plans. The groups are to run as efficiently as possible, providing benefit to the ACDM.
These new DMEs are to include individuals from the ACDM membership who are keen, willing and able to commit to the objectives outlined.
These groups are to meet on an agreed frequency, using the most appropriate meeting methods dependant on location of attendees/members. ACDM conference calling facilities are available if required, and the ACDM administration office are available to help with the signup and maintaining of membership of the DMEs.
Resources generated by the ACDM Data Management Expert Groups
Getting started with Audit Trail Review in Clinical Trial data: An Essential Guide: Symposium Slides
Date: November 7, 2024
Getting started with Audit Trail Review in Clinical Trial data- An Essential Guide
Date: September 23, 2024
The implementation of the evolving Clinical Data Science role, a cross collaborative initiative
Date: January 30, 2024
Embarking on a Decentralized Clinical Trial Journey – A Data Manager’s Guide
Date: December 6, 2022
Top considerations for Decentralised Clinical Trials (DCT) in data management
Date: August 8, 2022
ACDM Comments on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability”
Date: April 5, 2022
Click here
ICH E8 (R1) General Considerations for Clinical Studies Impact on Data Management
Date: April 5, 2022
Click here
EMA submission of comments on ‘Guideline on computerised systems and electronic data’
Date: January 27, 2022
Machine Readable Study Schedule of Activities Definition
Date: December 17, 2021
ICH E6 Guideline for Good Clinical Practice (GPC) – Update on Progress
Date: June 8, 2021
FDA 21 CFR Part 11 Subpart B Electronic Records Requirements & Annex 11 Computerised Systems – Suggested Implementation
Date: May 13, 2021
How to reduce the burden of wearables implementation in clinical trials
Date: May 28, 2020
Infographic – What do Data Managers need to know when considering wearables for their data collection?
Date: May 6, 2020
