The EU’s New Clinical Trial Regulation: How Sites and Sponsors Can Prepare for the Change
Product Details
The EU’s new Clinical Trial Regulation (CTR) went into effect Jan. 31, 2022, and sites and sponsors must now act knowing the CTR has absolute regulatory force. Have you changed your operations in accordance?
CTR compliance starts with The EU’s New Clinical Trial Regulation: How Sites and Sponsors Can Prepare for the Change.
Whether you’ve begun to prepare and want to ensure you have all the details covered or whether you don’t know where to start, this report features clinical trial experts in the EU providing their insights and advice on everything you must know, getting you ready for every aspect and all of the CTR’s implications for sponsors, sites and investigators.
The EU spent seven years discussing, developing and finalizing the CTR to give it the substance and authority the Clinical Trials Directive never had. The EU’s New Clinical Trial Regulation has the answers to all your burning questions to keep you compliant on and after Jan. 31, 2022. Think: Will member nations enforce the new rules strictly from the start or allow for a “break-in” period? Will the transition impact the number of trials or will it delay trials in 2022? And much more.
This report also incorporates a copy of the CTR and other valuable references, and compares the CTR to the current directive. Plus, it explains the role of the Clinical Trials Information System (CTIS) under the new regulatory scheme.
Management Report Takeaways:
- Differences between the directive’s guidance and the CTR’s requirements — and how to change over
- Enforcement and penalties for noncompliance — take these steps to prevent missteps
- How the new Clinical Trials Information System (CTIS) works
- How sponsors can use the CTIS to manage trials, trial staff, submissions and data
- What you must know about transparency requirements
- Which responsibilities and requirements will still be set by individual member nations
- Navigating the submittal process for applications to multiple member nations
If you’re a sponsor or site doing business in the EU and want to stay compliant, you need The EU’s New Clinical Trial Regulation: How Sites and Sponsors Can Prepare for the Change.
Who Will Benefit
- Research directors
- Principal investigators
- Regulatory/compliance officers
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ISBN-13:
978-1-60430-177-9
Publication date:
Nov. 2021
Page count:
357
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