Source Document Verification
This course reviews the methods of identifying different types of source documents and provides useful tips on how to perform remote verification or handle special cases, such as electronic source data, source documents that are missing or in different locations, or erroneous data. It also introduces a systematic process for source document verification and the logistics and skills involved in such a process.
Upon successfully completing this course, learners will be able to:
- Identify source documents and data
- Plan and efficiently perform source document verifications
- Establish compliance in data capturing
- Ensure credible scientific data
- Apply fraud detection methods (where applicable)
Monitors, clinical research associates, clinical trial assistants, study coordinators, clinical project managers, and regulatory and marketing professionals involved in clinical investigations are all welcome to participate in this course.
An understanding of the basics of good clinical practice, initiation visit activities, and monitoring mechanisms is required for this course.