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Accelerating Clinical Trials in the EU

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General publications11 September 2023
Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 August 2022, edition 5)
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General publications11 September 2023
Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 July 2022, edition 4)
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General publications11 September 2023
Key performance indicators (KPIs) to monitor the European clinical trials environment (1-30 June 2022, edition 3)
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General publications11 September 2023
Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 May 2022, edition 2)
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General publications11 September 2023
Key performance indicators (KPIs) to monitor the European clinical trials environment (31 January – 30 April 2022, edition 1)
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General publications24 July 2023
Annex II - Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) Version 1.1
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General publications24 July 2023
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 1.1
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General publications24 July 2023
Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) Version 1.1
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General publications31 January 2024
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. Version 1.4 includes question 3.4 on patient-facing document.

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General publications26 April 2023
Summary report on targeted consultation on the implementation of the Clinical Trials Regulation (EU) No 536/2014

A report is available summarising the findings of a survey for sponsors who submitted trials under the CTR. The survey was conducted in 2022.