Global Conduct Map
Creating a Central Repository of Information and Dynamic Links to Regulatory, Legal, Privacy, and Sources for DCTs
What is the Global Conduct Map?
The Global Conduct Map aims to provide a centralized library of regulatory, legal, and privacy insights for decentralized clinical trials (DCT). The resource will contain dynamic links to relevant regulatory references to make it easier for stakeholders to find the information they need to make decisions about executing DCTs globally. This project seeks to address the challenge of rapidly changing regulatory guidelines and the significant amount of information to review and collect.
Deliverables
Create a curated knowledge resource of regulatory, legal, and privacy information to help study teams understand what can be used, where it can be used, and any related operational conditions. Links to relevant regulatory documents are provided for the specific countries, relevant to DCT solutions (i.e., not to every clinical trial regulation). Please support us to keep the knowledge base current by submitting information to add to or correct our current understanding at the bottom of this page.
Global Conduct Map
The first tab is our consolidated assessment of the DCT Method Ease of Use by country. Other tabs contain links to the relevant guidelines and references available. We know that this information changes frequently. Please share your experiences and references so we can keep this information accurate and up to date by sharing additional information via the feedback form. The goal is to continuously update this table as new information is made available to the public.
Global Conduct Map Feedback
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