New MHRA Guidance

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

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FDA Guidance for Industry 

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

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Guideline on computerised systems and electronic data in clinical trials

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

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

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

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Recommendation paper on decentralised elements in clinical trials

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

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Welcome George Clinical as a new corporate member

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

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Welcome Clinion as a new corporate member

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

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Welcome ClinoSol Research as a new corporate member

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

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CTU DMEG Update

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

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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 . . .

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ACDM Comments on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability”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

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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 . . .

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