WebApr 18, 2024 · A new draft guidance from the European Medicines Agency (EMA) defines requirements for redacting commercially confidential information (CCI) in trial data and documents filed to the Clinical Trials Information System (CTIS). The guidance, designed to be a reference tool, defines CCI as any information provided in a trial application or … WebThe CTIS training programme is an important part of successful implementation of CTIS as it aims to facilitate user and organisation preparation for CTIS. The training strategy was revised in early 2024 with the aim to provide the CTIS users with the skills, capabilities and knowledge they need for a successful adoption of CTIS.
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WebMar 18, 2024 · CTIS functionality by asking questions to CTIS experts. More information EMA/168795/2024 Page 2/2 EMA plans to hold two walk-in clinics a month, with the first clinic on 28 March 2024 at 16:00 CET. Questions about the interpretation of the Clinical Trial Regulation and/or national processes are out of the scope of the walk-in clinics. ... WebTraining and supporting materials are available from the European Medicines Agency (EMA) on how to use the Clinical Trials Information System (CTIS) ahead of its planned launch … now pride
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WebCTIS storage: The system allows for storage of clinical trial data with a maximum size of 220 GB. • Sponsors data fields: The CTIS Structured data form Instructions document provides guidance on the data fields sponsors will fill in CTIS … WebCTIS 68,047 followers on LinkedIn. CTIS is a SONDA Group company. To learn more visit our website at the button below! CTIS, a SONDA Group company, is recognized as one … WebAlthough the Regulation will enter into force on 31 January 2024, Sponsors can elect to conduct new trials under either the old Directive or the new Regulation until 31 January 2024. After this date, all new trial applications must be submitted in the CTIS under the new Regulation. Additionally, Sponsors have until 31 January 2025 to transition ... nicol southall