Standardizing Principal Investigator Delegation Records: An Alternative Approach for Sites
A Complion Feature Article [Plus 7 Free Templates]
Drawing on the insight and experience of two professionals with decades of clinical research management experience, Standardizing Principal Investigation Delegation Records: An Alternative Approach for Sites, offers specific advice -- and tools -- for establishing an efficient system for documenting the delegation of responsibilities that can easily be adapted to your organization, whether you are running a single trial in a single site, or multiple trials across a network of sites.
In the article, Nadine Nemunaitis, Vice President of Research Operations, and Staci Horvath, Director of Operations for the Mary Crowley Cancer Research Centers, describe in detail a delegation of authority documentation process that has been refined over 16 years and spans over 40 trials per year.
The article presents not only their unique experience with investigation delegation record-keeping, but also offers document templates you can customize for use in your organization, including:
- Delegation of Responsibility Form for a Clinical Research Coordinator
- Delegation of Responsibility Form for a Clinical Research Nurse
- Delegation of Responsibility Form for an Investigator
- Delegation of Authority Template
- Implementation Checklist
- SOP Development Tool