NIS Training

CHCUK-NISCHCUK 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

CHCUK prides itself in our ability to deliver client-specific training courses.  Please do contact us if you can’t see the exact course you’re looking for and we’d be happy to work with you to deliver the training solution you need.

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:

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

CHCUK Global E-learningNon-Interventional Study (NIS) eLearning Modules