Welsh Government

Managing essential documents in research

Facilitators: Health and Care Research Wales Training Facilitators 

Course Outline:  

High-quality systems and documentation are essential for the conduct of clinical trials and other research. This half day course is aimed at those research professionals and staff (e.g. research officers, clinical studies officers, research nurses/practitioners and administrators) who wish to improve their knowledge and skills in the trial management processes and maintenance of essential documentation.  

The training will address the GCP standards and research governance, responsibilities of research staff with regard to investigator site file management, essential documents and quality systems. 

Please note a certificate of attendance will only be issued if delegates complete all elements of the training. Times will be confirmed on receipt of the registration form.

  This course is accredited by the CPD Certification Service (4 Hours)


Following the training, participants will be able to: 

  • have increased knowledge of the standard required by GCP for the management of essential documents within NHS premises;
  • describe individual and team responsibilities;
  • understand the structure and purpose of the trial site file and other essential documents;
  • explore the management of essential documentation within a workshop.  

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