The Clinical Document Management and Collaborative Electronic Data Exchange in Clinical Trials is a webinar that covers topics such as:
- Documentation needs in the context of paper, electronic and hybrid document management systems
- Documentation requirements for a trial based on the protocol and the geographical location
- Roles from the Sponsor, site and CRO perspective
- Roles and responsibilities of the team members with regards to the trial documentation;
- Essential Document List
- SOPs required to run the trial and who has responsibility for them
- Audits: Site, CRO and in-process trial audits
- Trial Master File and differences from the Essential Document list
The Clinical Document Management and Collaborative Electronic Data Exchange in Clinical Trials brings together CRO Staff Members, Project Managers, Directors and Leaders, Clinical Investigators and Study Coordinators, Site and Sponsor Staff Members, Clinical Trial Managers, Monitors and Associates, Clinical Operations Directors and Senior CRAs, Quality Assurance Personnel, Medical Affairs and Clinical Operations Professionals, Document Management Staff, Central Records Staff, IRB Members, Regulatory Managers and Privacy Officers.
