Tubestop - Ethics & Regulatory Submission

Description

The regulatory and ethics submission/review process for clinical trials is a multi-step process that ensures the safety and ethical conduct of clinical trials.

The regulatory and ethics submission/review process for clinical trials is a complex and time-consuming process. However, it is essential to ensure the safety and ethical conduct of clinical trials. The process typically involves the following steps:

Pre-submission: The sponsor and investigator work together to develop the clinical trial protocol and other regulatory documents.
Submission: The sponsor submits the clinical trial protocol and other regulatory documents to the relevant regulatory authorities. Depending on the ethics board used, the sponsor or the investigator submit the protocol and all associated documents, including any patient facing materials for review and comment.
Review: The regulatory authorities and ethics review boards review the clinical trial protocol and other regulatory documents to assess the safety and ethical conduct of the trial.
Approval: If the clinical trial protocol and other regulatory documents are approved, the trial can begin.

The regulatory and ethics submission/review process for clinical trials can vary depending on the country or region where the trial is being conducted. However, the general steps involved are the same.

DCT-specific Considerations/Inputs

The protocol and ICF must include descriptions of the DCT methods to be used.

What adjustments to the submission materials need to be made to conduct the DCT trial using the selected methods, processes and technologies? (Global Conduct Map)

Consider the format in which the review bodies expect to receive the submission (e.g., screen shots, wireframes)

Note that FDA Draft Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices outlines Informed Consent and Institutional Review Board Oversight recommendations. (Section 3E)

Are the formats of the submission documents sufficient/adequate to perform an Ethics Committee and Regulatory Authority Review? (Global Conduct Map)

Several reference documents from MRCT IRB/EC Considerations are provided below in the References section.

U.S. FDA Final Guidance Document: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties - September 2024

Ethics & Regulatory Submission

Description

DCT-specific Considerations/Inputs

Tools

Regulatory Documents

FDA/U.S.

Europe/EMA

Reference Documents