Trial Planning
The purpose of the Trial Planning Stop is to create a Study Protocol.
Description
Clinical trial planning is the process of designing and planning the execution strategy for a clinical trial to study a scientific question. Decentralized clinical trial planning is the process of designing and planning how to execute clinical trials as above, using technology and services that allow patients to participate remotely. These trials may also use electronic data collection devices and remote monitoring.
DCT-specific Considerations/Inputs
Define Key Performance Indicators (KPIs), Assessment Methodology, Assessment of DCT value versus Traditional Trial
Glossary of Terms
DCT Curriculum
Regulatory Documents
FDA/U.S.
U.S. FDA Final Guidance Document: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties - September 2024
ViewU.S. FDA Draft Guidance Document: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
ViewU.S. FDA Draft Guidance Document: Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials
ViewEurope/EMA
European Medicines Agency Recommendation Paper on Decentralised Element in Clinical Trials Version 01, 13 December 2022
ViewReference Documents
TransCelerate Patient Technology Patient Considerations Toolkit
ViewTransCelerate Patient Technology Patient Considerations Toolkit
ViewTransCelerate Patient Protocol Engagement Toolkit
ViewTransCelerate Patient Technology Tools Industry Designing Clinical Trials Patient Vendor Input
ViewTransCelerate Study Participant Feedback Questionnaire Toolkit
View