Skip to content

ICH E8 (R1) General Considerations for Clinical Studies Impact on Data Management

Date: April 5, 2022

The ACDM Regulatory Considerations have reviewed the Revision 1 to the ICH E8 Guidelines and have provided an overview here.

 


 

Explore More News

Welcome Climedo as a new corporate member

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

Read More

Clinical Trials for Medicines – New Notification Scheme

The MHRA have recently launched a new notification scheme, the first step in their . . .

Read More

EMA Management Board: Highlights of October 2023 meeting

The EMA’s Management Board met on 5 October in Amsterdam. The article below covers the . . .

Read More

Welcome Mednet as a new corporate member

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

Read More

Welcome Allucent as a new corporate member

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

Read More

Welcome KCR as a new corporate member

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

Read More

Welcome Debiopharm as a new corporate member

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

Read More

HMA/EMA joint Big Data Steering Group: Big Data Workplan 2023-2025

The joint HMA-EMA Big Data Steering Group (BDSG) have released their latest workplan, . . .

Read More

ACT EU PA04 – Multi-stakeholder Workshop on ICH E6 R3

As part of the Accelerating Clinical Trials in the EU (ACT EU) multi-annual workplan . . .

Read More

European Medicine’s Agency – Reflection paper on the use of artificial intelligence in the lifecycle of medicines

The EMA has opened a public consultation on a reflection paper presenting views . . .

Read More

Welcome Instem as a new corporate member

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

Read More

Regulatory Considerations Expert Group reviews draft FDA Guidance

The ACDM Regulatory Considerations Expert Group have reviewed and submitted comments on . . .

Read More