In this recorded webinar, CRIO brings together a panel of industry experts to examine one of the most debated topics in clinical operations: whether sponsors should provide standardized, study-specific source document templates to investigative sites.
The discussion explores the operational, legal, and regulatory considerations behind template standardization, outlining both the potential benefits and inherent risks of study-specific source document templates. Viewers will gain clarity on why perspectives differ across the industry and what current guidance, expectations, and best practices exist today.
Key topics covered in this webinar include:
- Why this issue continues to spark debate
- The advantages of sponsor-provided source templates
- Compliance concerns and operational risk considerations
- Regulatory and legal interpretations
- Practical insights for moving forward with greater confidence
Speakers:
Doug Schantz (Asklepios BioPharmaceutical)
Edye Edens (EDEE Law)
Dr. James Clark (Alcanza)
Melissa Gottschlich (ICON)
Moderator:
Raymond Nomizu, Co-CEO, CRIO