Documents (178)
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Report to monitor the European clinical trials environment (1-30 September 2022, edition 6)
Report to monitor the European clinical trials environment (1-31 August 2022, edition 5)
Report to monitor the European clinical trials environment (1-31 July 2022, edition 4)
Report to monitor the European clinical trials environment (1-30 June 2022, edition 3)
Report to monitor the European clinical trials environment (1-31 May 2022, edition 2)
Report to monitor the European clinical trials environment (31 January – 30 April 2022, edition 1)
Complex clinical trials – questions and answers
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Recommendation paper on decentralised elements in clinical trials
Annex I - Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) Version 2.2
Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) Version 2.2
Outcome of public consultation on ACT EU MSP participation and priorities for discussion
The report on the outcome of a public consultation where the European Medicines Agency invited stakeholders to provide input on the ACT EU MSP concept paper, priority topics for the MSP and to express their interest in participating.
Advice on medicines for human use in the EU medicines regulatory network
Q&A on the protection of commercially confidential information and personal data while using CTIS
Updated guidance is available for CTIS users on how to protect personal data and commercially confidential information.
Accelerating clinical trials in the EU (ACT EU) - Delivering an EU clinical trials transformation initiative
ACT EU training strategy
ACT EU multi-stakeholder platform concept paper
A concept paper is available on the importance of engaging stakeholders in all phases of a clinical trial, including trial design, and the objectives, composition, governance and transparency rules for the multi-stakeholder platform.
ACT EU multi-annual workplan 2022-2026
Report on the 2022 survey on the implementation of the Clinical Trials Regulation
A report is available summarising the findings of a survey for sponsors who submitted trials under the CTR. The survey was conducted in 2022.
