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

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

ICH E8 (R1) General Considerations for Clinical Studies Impact on Data Management
The ACDM Regulatory Considerations have reviewed the Revision 1 to the ICH E8 Guidelines . . .
Read More

ACDM Comments on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability”
https://acdmglobal.org/wp-content/uploads/2022/04/ACDM_FDA_DHT.pdf
Read More

Have your say – MHRA’s public consultation on proposals for legislative changes for clinical trials
Dear Colleague,
We have just launched our 8-week public consultation on proposals for . . .
Read More

Signant Health are ACDM22 Photography sponsors
The Association for Clinical Data Management are delighted to announce that Signant Health . . .
Read More

Anju Software is exhibiting at ACDM22
The Association for Clinical Data Management is delighted to announce that Anju Software . . .
Read More

SGS Health Science to sponsor ACDM Awards for the second year running
The Association for Clinical Data Management are delighted to announce that SGS Health . . .
Read More

ACDM Interactive
The ACDM would like to thank everyone involved with ACDM Interactive in Manchester. The . . .
Read More