Non-Interventional Study (NIS) Training
CHCUK provide a comprehensive range of training solutions that can be tailored to suit your needs and can be delivered as eLearning, Webinars and/or face-to-face training. Refer to the eLearning section below for an illustration of the country-specific NIS courses available.
Off-the-Shelf NIS Training Modules
Each of our off-the-shelf training courses explores the Country-specific requirements when conducting non-interventional studies in your chosen and looks specifically at:
- Regulatory classification
- Regulatory framework/applicable legislation and guidelines
- Approval requirements and timeframes
- Submission documents
- Responsibilities - Sponsor, PI, CRO etc
- Practical considerations - Data privacy, study registration, REC submissions and notifications, biosample collection, genetic research considerations
- Industry best practice
Each of the courses comes with hand-outs of the training materials, as well as a country-specific tools and resources report that is intended as a comprehensive reference tool.
Bespoke NIS Training Modules
Email: info@chcuk.co.uk
Phone: +44 1997 423311
Post-Authorisation Safety Study (PASS) Training
There are new European legal requirements for Post-Authorisation Safety Studies (PASS) effective from 21 July 2012:
- Regulation EU/520/2012
- Regulation EC/726/2004 (as amended by Regulation EU/1235/2010 )
- Directive 2001/83/EC (as amended By Directive 2010/84/EU )
- EMA GVP Module VIII
- EMA Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies (Sept 2012)
These requirements are more stringent than was previously seen for PASS. All obligatory PASS (and voluntary?!) must comply with the new PASS requirements. Therefore, it is important that you correctly classify your study during the planning phase because there are significantly different requirements for non-interventional PASS than for other non-interventional studies.
CHCUK offers client-specific training aimed to ensuring that all staff, including affiliates, are made aware of, and understand, the implications of the new requirements
Free NIS Course Material Samples and eLearning Demonstrations
Please contact us if you would like a free demonstration of the eLearning NIS Training and/or some free samples of the course materials
Email: info@chcuk.co.uk
Phone: +44 1997 423311
Non-Interventional Study (NIS) eLearning Modules
