In the present world of evolving protocols and study requirements, it is very important that there is very efficient study build to achieve the primary and secondary objectives with effective data management. Most of the study build are not as effective as it should be. We try to blame the protocol for the same. However, there is need for a very aggressive approach from data management to design the study in database so it should avoid duplication of efforts, less manual work, easy to adapt the changes in protocol, more innovative in addressing some of the key challenges during the conduct phase, easy to map with standards, effective in integrations etc.
The purpose of this abstract is to provide the present challenges and data management needs for designing and deploying effective and efficient clinical studies on EDC databases. The information in this presentation can help the industry with best solution and good techniques which can help the data management group deliver best quality studies with competitive timelines.
In present world there is a need for aggressive deliveries or electronic studies, however the basic challenges data management face with respect to:
Review Clinical trial protocol
Build eCRFs on EDC tool, Visit structure, Build data validations, Labs
Design Specifications and/or DMP, Design Papar CRFs and eCRFs
Quality control, User Acceptance