Summer 2005
ACDM Senior Clinical Data Managers’ Forum
8th June 2005 Meeting
The Impact of EDC on the Role of the Data Manager
I recently attended the ACDM Senior Clinical Data Managers’ Forum at the Renaissance Hotel in Reading.
Senior Clinical Data Managers’ Forums are held regularly throughout the year and members must have 5 years experience in CDM with either line or project management experience. Meetings are usually held in the South East and run from lunch time, finishing with a meal in the evening, a good mix of industry news and exciting gossip!
The agenda for the meeting consisted of a keynote presentation by Adam Baumgart (Kendle), followed by 2 case studies, looking at the role of the Data Manager, and how the EDC system had been implemented in 2 companies, presented by Carol Hoyle (i3 Statprobe) and Arvinder Virdee (GlaxoSmithKline). Breakout groups and presentations of feedback on discussions followed.
Adam began by setting the scene and describing the benefits of using EDC, and providing some interesting metrics – e.g. page costs estimated at $6-7 in EDC compared to $10-13 in paper. Moving on, Adam described how EDC affects the different roles; for example the Investigator and site staff, CRAs etc, and made comparisons between paper and EDC. The tables below are taken from Adam’s presentation.
A high level comparison of the tasks to be performed between paper and e-Trials shows the major benefits of using an EDC system. The high up-front workload for an EDC system is compensated for by allowing more in-stream processing and resulting in earlier delivery of Data Management's key deliverable – i.e. the clean study data.
Adam's presentation finished off by introducing a few of the EDC tools available, which led on nicely to the case studies.
The presentations were all interesting and informative; having experience of using InForm, it was nice to see an overview of a different EDC system – OC RDC. The break out groups had lively discussion on the impact of EDC on the role of the Data Manager and eSource.
Some of the feedback from the break out groups highlighted that the skill set of the Data Manager would need to change, moving away from the life science background to a more technical role – for those designing the eCRF, and more project management for those managing the data. Delegates had different experiences of merging roles and responsibilities, such as CRA and DM, programming and DM. The discussions were thought provoking and there were many different ideas of how the role of the Data Manager will continue to evolve with the implementation of EDC.
There was a dinner following the forum where the discussion continued, although the topics changed to more light hearted matters!
Overall, the forum was enjoyable, it's always great to meet other Data Managers and hear what is happening in other companies!
Paper versus EDC
Paper CRF process observations Impact of EDC
Hand-overs Minimised
Batching 'wait' points Eliminated
Continuous processing
Reduced wait times
No accumulated paper CRF or query bolus
Paper management Eliminated
No transport
No physical processing or tracking
Reduced load on staff
Duplication of work Double data entry eliminated
Query duplication eliminated
Reduced CDM FTEs
Reduced DE errors
Query process delayed Queries presented at the point of entry
No query transportation issues
Core Task Paper e-Trial
Design protocol At study planning stage Finalised protocol is critical for database design
Design data collection tool Design and print CRF Build database and edit checks eCRFs,
Extensive testing
e-Help
Conduct trial Highly reactive Proactive
Collect data CRF, double entry, data uploads in data management Single entry and cleaning at investigator site
Check and clean data Track, clean, query, edit, external data cleaning Minimised, ongoing edits, external data cleaning
Analyse and use data Late visibility Early visibility