USA

DCT Feasibility Assessment USA The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This guidebook provides an overview of the current and proposed regulatory landscape applicable in the USA in relation to Decentralized Clinical Trials (“DCTs”) with investigational medicinal products. The Food and Drug Administration (FDA) ...

2.1 Name of Regulatory Authority U.S. Food and Drug Administration: the FDA is the regulatory authority that regulates clinical investigations of medical products in the U.S. Within the FDA there are several centers. The ones responsible for...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant. The FDA has published a list of FAQs: Institutional Review Boards Frequently Asked Questions &n...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  The sponsor is required to submit an Investigational New Drug (IND) application to the FD...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)? Whilst we have not been able to formally identify that a PI/CI is required to be approved/registered by any regulatory authority, 21CFR312...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. 49CFR173.134 provides for the shipment of biological materials. Biological specimens fall into Division 6.2 – infectious substances . {(“Infec...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? Yes . 7.2  Is there any specific regulation/guidance on the use of DC...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   In the USA, the “ HIPAA Privacy Rule ” established the conditions under which protected health information may be used...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ?   Yes , advertisements on social media are permitted. The U.S. Nation...

10.1 Clinical Trial with Investigational Medicinal Product The NIH has provided the following roadmap: 10.2 Pediatric Investigation Plan (PIP) The FDA and the European Medicines Agency (EMA) have jointly produced a Pediatric Stu...

Food and Drug Administration (FDA) https://www.fda.gov/ Center for Drug Evaluation and Research (CDER) https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder   Center for Biologics Evaluation and Res...

From time to time, the FDA tends to update its forms. Therefore, in order to ensure that the most up-to-date form is used, we suggest that any forms required are obtained directly from the FDA website.