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Appendix 1. Confidentiality Advisory Group Sub Committee MinutesMinutes of the meeting of the Sub Committee of the Confidentiality Advisory Group
MAY 20191. NEW APPLICATIONS
NameNotesDr Patrick CoyleViceChairDr
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Who needs non-ctimp standard conditions?
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Researchers conducting non-CTIMP (Clinical Trial of an Investigational Medicinal Product) studies.
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Institutions or organizations overseeing non-CTIMP trials.
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What is non-ctimp standard conditions?
Non-CTIMP standard conditions refer to the standard terms and conditions that apply to clinical trials that are not investigating investigational medicinal products.
Who is required to file non-ctimp standard conditions?
The sponsor or investigator conducting the non-CTIMP clinical trial is required to file the standard conditions.
How to fill out non-ctimp standard conditions?
Non-CTIMP standard conditions can be filled out by providing all required information such as study details, informed consent procedures, safety reporting requirements, and any other relevant information.
What is the purpose of non-ctimp standard conditions?
The purpose of non-CTIMP standard conditions is to ensure that non-investigational medicinal product clinical trials are conducted in accordance with ethical and regulatory requirements.
What information must be reported on non-ctimp standard conditions?
Information such as study protocol, participant inclusion/exclusion criteria, study procedures, safety monitoring plans, and data management procedures must be reported on non-CTIMP standard conditions.
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