Skip to content

Guidance for Industry: Conducting Clinical Trials With Decentralized Elements

Date: September 23, 2024

The Conducting Clinical Trials With Decentralized Elements final guidance has now been released, and provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials.

Read here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-clinical-trials-decentralized-elements

 


 

Explore More News

ICH GCP E6 Revision 3 is here. Regulatory Considerations Expert Group to review

The R&D industry, especially those that are working on clinical trials, have been . . .

Read More

Welcome Algorics as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome Algorics as a . . .

Read More

Consultation response on legislative proposals for clinical trials

The MHRA have published the public consultation response to the proposals to reform the . . .

Read More

New MHRA Guidance

The MHRA have published new guidance on ‘Software and Artificial Intelligence (AI) as a . . .

Read More

FDA Guidance for Industry 

The FDA has issued a final guidance to provide information on risk-based approaches to . . .

Read More

Guideline on computerised systems and electronic data in clinical trials

The European Medicines Agency (EMA) have published the new guidelines on computerised . . .

Read More

Welcome IROS – Insights Research Organization & Solutions as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome IROS – Insights . . .

Read More

Recommendation paper on decentralised elements in clinical trials

Following their meeting on 4 Oct, the EMA/HTAs and EC have published a recommendation . . .

Read More

Welcome George Clinical as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome George Clinical . . .

Read More

Welcome Clinion as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome Clinion as a . . .

Read More

Welcome ClinoSol Research as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome ClinoSol . . .

Read More

CTU DMEG Update

The CTU DMEG has been actively discussing common problems that data managers face in . . .

Read More