Why Should You Attend:

Conducting clinical trials and collecting accurate and viable data is an essential and costly component of the drug development paradigm. Sponsors, CROs and 3rd party vendors are held accountable to ensure the most efficient and effective delivery of high quality data from each and every trial that they complete. In the larger research community, clinical trials may have subject matter experts, Although the pharma industry is moving forward with electronic data transfer for many aspects of a trial, how those data are collected, reviewed, archived and retrieved is an arduous task for clinical teams. With collaborative partnerships and data sharing to rapidly address patient needs, data sharing and transport must safeguard the integrity of the data and at the same time ensure patient privacy. Many of the clinical trial team must understand the nature of any legal, regulatory, proprietary or ethical restrictions that may impinge upon a proposed data exchange and complying with HIPAA Privacy Rule (45 CFR Part 160 and Part 164 Subparts A and E).

Areas Covered in the Seminar:

- Documentation requirements for a trial based on the protocol and the geographical location
- Documentation needs in the context of paper, electronic and hybrid document management systems
- Roles and responsibilities of the team members with regards to the trial documentation;
- Roles from the Sponsor, site and CRO perspective
- SOPs required to run the trial and who has responsibility for them
Essential Document List
- Trial Master File and differences from the Essential Document list
- Audits: Site, CRO and in-process trial audits
- Data Sharing with Researchers, Data Safety Monitoring Boards and HIPAA Privacy Rule (45 CFR Part 160)
- Benefits and Requirements of Electronic Data Use Agreements and Organizational Framework (SOPs)