On April 21st, 2021, EMA confirmed that CTIS is fully functional and meets the functional specifications, so that CTIS will be the single entry point for submitting clinical trial information in the EU.
CTIs will go live when the Clinical Trial Regulation (CTR) 536/2014/EU becomes applicable, foreseeable on January 31st, 2022, and it will repeal the existing Clinical Trial Directive 2001/20/EC and national legislation that was put in place to implement the Directive. It will also apply to trials authorised under the previous legislation if they are still ongoing three years after the Regulation has come into operation.
ASPHALION can offer you support and information to facilitate this process. The key concepts for preparation at this time include:
- Clinical Trial Regulation 536/2014/EU basics
- Organisation Management Service (OMS) requirements
- Extended EudraVigilance medicinal product dictionary (XEVMPD) requirements
- Identify “CTIS personas” within a company for training purposes
- Identify role and permission strategies for within a company
- Evaluate clinical trial work flow and procedures to map to new CTIS functionality and day to day use
- Identify strategies for the transition period for existing and/or new trials
- Identify local requirement needs in addition to centralised CTIS functions
- Transparency requirements and strategy
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