%20(2).svg "DIGITAL (250 x 117 px) (2)")
1572 CoLab
1572 and Regulatory Document Recommendations for Digital Clinical Trials
1572 and Regulatory Document
Recommendations for Digital Clinical Trials:
Scope
Recommendations on if/how to best include digital clinical trial-specific roles and needs (eg. local labs, local imaging, local healthcare providers) using the 1572 or other forms
1572 and Regulatory Document
Recommendations for Digital Clinical Trials:
Deliverables
Create recommendations for 1572 / regulatory form completion to document
- Conduct of digital trial assessments
- Oversight responsibility for digital trial assessments
- Use of virtual sites / metasites, mobile nursing services, retail pharmacy, local community physicians, local imaging centers, local labs, and appropriate documentation guidance
Decision elements to determine appropriate documentation of delegated trial-related activities
Resource Table - Traditional & Digital Clinical Trials Roles and Documentation Recommendations
Use this to as a guidance on how completing the forms is similar and different between innovative clinical trials and traditional trials
Decision elements to determine appropriate documentation of delegated trial-related activities
Use this tool to help consider which roles are documented in which forms based on the activities they are performing.
Decision Elements regrading Standard of Care Practice
Use this tool to help decide which procedures could be considered standard of care and what questions to ask.
Scenarios for PI Oversight and Delegation of Trial-Related Activities
The Co-Lab Team created two trial scenarios and examples on the documentation for each. We've created one scenario for an RSV trial and one for a rare disease trial. Each scenario includes:
- A patient journey map
- A simple explanation of how one site will operationalize the trial.
- An annotated 1572 form and the DOA / Task log that aligns to that site model