A
Henry Stewart 2-Day Briefing
Designing,
Writing and Implementing
SOPs
for EDC
Managing
the Change
•
Solving the practical problems
• Adapting existing SOPs to the EDC environment
• Writing the essential new SOPs
Many
companies are now changing their practices in clinical trials from
paper based data entry to an electronic data capture (EDC) system.
The change of practice requires different processes and therefore
different SOPs for the workflow process.
This
conference will address, in the form of presentations, case studies
and interactive workshops, the differences in the workflow process
applicable to EDC and will provide delegates with an insight into
which SOPs need to be rewritten, edited or retired in the transition
to an EDC system.
Topics
covered include:
-
What is EDC?
-
SOP considerations in an EDC system
-
Training for EDC based clinical trials
-
SOPs for designing eCRFs
-
IT SOPs for EDC systems – what SOPs need to be in place from a security/system perspective?
Case
studies from expert speakers from Pfizer, Amgen and Research Dynamics
Consulting Group will give delegates an insight into how the implementation
of an EDC system occurs at sponsor, CRO and site level, what SOP issues
arise and how they are solved.
Interactive
workshops will give delegates the opportunity to work through actual
process mapping and SOP content development in a totally risk-free
environment.
Attendees
will leave the conference not only understanding more about EDC, but
how it impacts SOPs, which SOPs are most likely in need of change,
and what the new content might look like, as well as having SOP templates
to take away with them to use in-house.
Full documentation and SOP templates will be provided to all delegates and adequate time set aside for discussion and questions.
Monday,
16 & Tuesday, 17 May 2005
Wyndham Washington Hotel, Washington DC