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 to influence DTRA’s regulatory policy strategy. This project conducted and provided a gap analysis of current regulations related to decentralized clinical trials (DCT) and provided proposals to drive awareness and inform regulatory agencies of the gaps in such regulations. The goal of the initiative is to leverage this analysis to engage with regulators, respond to newly released guidance/regulations, and ultimately propose collaborative solutions to address regulatory uncertainties.
New initiatives or other working groups may be chartered based on findings from this initiative. As a conclusion to this work, this workstream has been absorbed into DTRAs Regulatory Forum, which meets monthly and drives forward different work in the Regulatory space for DCTs.
- Gap analysis of current regulatory gaps for DCT conduct
- Integration of gap analysis resources into DCT Tubestop
- Close coordination with DTRA’s regulatory forum to drive engagement with global regulators around identified gaps and proposed solutions
Regulatory Gap Analysis Feedback
National Principles for Teletrials in AustraliaView
The Danish Medicines Agency’s guidance on the implementation of decentralised elements in clinical trials with medicinal productsView
EMA Recommendation Paper on Decentralised Elements in Clinical TrialsView
FDA Draft Guidance - Decentralized Clinical Trials for Drugs, Biological Products, and DevicesView
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human UseView
Swedish Medical Products Agency - Decentralised Clinical Trials PaperView
Position Paper on decentralized clinical trials (DCTs) with medicinal products in SwitzerlandView
Digital Tool in Clinical TrialsView