Conference Description:

Clinical trials are a critical element of drug development. Introducing the investigational products to consenting subjects under Good Clinical Practices (GCPs), the Essential Documents are evidence of the compliant conduct of a clinical trial.
Learning Objectives:

>. Recognize the purpose and value of documents, files and data as assets in a drug development program

>.Identify industry best practices and their use and adoption

>.Distinguish paper and digital formats and understand transitioning from paper

>.Demonstrate an understanding of the complete life cycle of regulatory content

>.Discuss Best Practices for Essential Documents in their handling and storage.

>.Discuss the benefit and challenges of partnering with CROs and FSPs




Who Should Attend:

>. Records Management Specialists at Sponsors, CROs, FSPs, Vendors, Clinical Sites
>. Personnel involved in set up, maintenance, and auditing of the Trial Master File
>. Project and/or Study Managers
>. Project and/or Clinical Trial Assistants
>. Clinical Operations Administrators
>. Clinical Research Monitors