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Collaborate on Regulatory Gaps
Identifying and Closing Gaps in DCT-Relevant Regulations
What is This Initiative?
This initiative collects current DCT regulations and identifies relevant gaps within regulatory guidance and policy. This project aims to conduct and provide a gap analysis of current regulations related to decentralized clinical trials (DCT) and provide a proposal that drives awareness and informs regulatory agencies of the gaps in such regulations. The goal is to identify what is missing in the regulations and offer solutions to drive change. New initiatives or other working groups may be chartered based on findings from this initiative.
Deliverables
A gap analysis of where current regulations are not addressing DCT, a proposal to guide health authorities with the process flow around DCT, and a list of regulators responsible for DCT in each country.
Download the
Full Initiative Charter
Relevant Resources
National Principles for Teletrials in Australia
ViewThe Danish Medicines Agency’s guidance on the implementation of decentralised elements in clinical trials with medicinal products
ViewRecommendation Paper on Decentralised Elements in Clinical Trials
ViewDecentralized Clinical Trials for Drugs, Biological Products, and Devices
ViewInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
ViewDecentralized Clinical Trials
ViewPosition Paper on decentralized clinical trials (DCTs) with medicinal products in Switzerland
ViewDigital Tool in Clinical Trials
View