Confirm DCT aligns with Regulatory Requirements
The purpose of the Confirm DCT aligns with Regulatory Requirements / Guidances is to ensure that all the trial design and execution plan aligns to regulatory frameworks for clinical trials, including those from FDA/EMA (or other country-specific regulatory agencies). This also needs to take into account any Regulations that pertain to Decentralized Clinical Trials specific to the country where the trial is occurring, along with any timing impact based on implementing a DCT method or service.
Description
As with all trials, regulatory considerations in decentralized clinical trials include ensuring compliance with applicable regulations and protecting the rights and safety of participants. Some of the key regulatory considerations in decentralized clinical trials include:
Compliance with applicable regulations: Decentralized clinical trials must comply with all applicable regulations, including those governing the conduct of clinical trials, the protection of human subjects, and the privacy of health information.
Protection of the rights and safety of participants: Decentralized clinical trials must protect the rights and safety of participants. This includes ensuring that participants are fully informed about the risks and benefits of the study, that they are not coerced into participating, and that they have access to emergency care if needed.
The regulatory requirements are similar - and the methods to achieve compliance may differ in DCTs by using technology or other mechanisms to ensure compliance. By taking these regulatory considerations into account, sponsors and investigators can help to ensure that decentralized clinical trials are conducted in a safe and ethical manner.
DCT-specific Considerations/Inputs
Country-specific regulations impacting a DCT:
Collaborate on Regulatory GapsRegulatory Documents
FDA/U.S.
U.S. FDA Final Guidance Document: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties - September 2024
ViewFDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
ViewFDA: Payment and Reimbursement to Research Subjects
ViewEurope/EMA
EMA Guideline on computerized systems and electronic data in clinical trials
ViewThe Danish Medicines Agency’s guidance on the implementation of decentralized elements in clinical trials with medicinal products
ViewPosition paper by Swissmedic and swissethics on decentralized clinical trials (DCTs) with medicinal products
ViewEMA Recommendation Paper on Decentralized Elements in Clinical Trials
ViewGuidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic
ViewReference Documents
CTTI Considerations for Advancing the Use of Digital Technologies for Data Capture & Improved Clinical Trials
View