Winter 2005/06
Fundamentals of Electronic Data Capture
The first ACDM course for Fundamentals of Electronic Data Capture took place in London on the 17th November. Twelve people from as far a field as Scotland and Denmark came together to attend.
We all had different expectations of the course. How will EDC change my job? How will EDC change Data Management? Our Trainers were Emma Banks, Head of Data Services as Datatrial and Arv Virdee a Senior Clinical Data Scientist at GSK.
After introductions and a getting to know you session, the History of EDC, Different EDC Systems and using EDC were covered and discussed. Practical hands on group work provoked vigorous discussion covering activities carried out during Study Set Up, Conduct and Closure of an EDC study. It became obvious that time and effort and communication during the set-up phase is needed for EDC studies. The take home message from this session was that EDC does take longer to set-up, but this should be compensated by the reduction in effort during the conduct and closure phases.
Rules, Regulations and Responsibilities were covered after lunch. Pros and Cons of EDC were discussed. Some of the attendees already used EDC and it was useful to talk about the kinds of studies best suited to EDC. This session clearly illustrated that the area of EDC is not an exact science at the moment and that there are various thoughts and ideas on how EDC should be approached both now and in the future. After a tea break we returned to a discussion and presentation about EDC collection from other sources (e.g. labs, ECG).
In summing up bringing together key groups of staff in the study set-up period and communication between these groups is paramount to the smooth running of an EDC study.
Training was thought to be equally important for all staff especially Nurses and Investigators who will have responsibility for gathering and input of data in a timely manner.
This One-Day course gives an excellent overview of EDC and how it will change the future of Data Management. We found the whole day of great benefit, not only in the course content itself, but also in the discussions that were raised from it and discovering the various different ways companies are approaching this subject.
Sharon Fenn and Roy Staples
Kendle International