Collaborate on Regulatory Gaps

Identifying and Closing Gaps in DCT-Relevant Regulations

Group 8

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.

Group 8


  • 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 
Gap Analysis-1

1. Gap Analysis Spreadsheet as of July 2022

Team completed a Gap analysis of where current regulations are not addressing DCT conduct with outreach/engagement with Regulatory Authorities as appropriate

Group 396

2. FDA Draft Guidance Response

DTRA Membership collaborated and compiled a robust response to the FDA on the Draft Guidance for DCTs.

Draft Guidance-1

3. DTRA Response to NIH Request for Information

DTRA Membership shared comments on how DCTs may be designed to be more effective, efficient, and equitable to bring more interventions to all people, faster.

Group 8 Blue Background

Regulatory Gap Analysis Feedback

Relevant Resources

National Principles for Teletrials in Australia


The Danish Medicines Agency’s guidance on the implementation of decentralised elements in clinical trials with medicinal products


EMA Recommendation Paper on Decentralised Elements in Clinical Trials


FDA Draft Guidance - Decentralized Clinical Trials for Drugs, Biological Products, and Devices


International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use


Swedish Medical Products Agency - Decentralised Clinical Trials Paper


Position Paper on decentralized clinical trials (DCTs) with medicinal products in Switzerland


Digital Tool in Clinical Trials


Download the
Initiative Charter