Managing Essential Documents in Research

Course outline:

High-quality systems and documentation are essential for the conduct of clinical trials and other research. This  e-learning 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.

Course length:

15-20 minutes for each module

Course details:

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

Following the training, participants will:

• 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

CPD certification:

This training has been certified by the CPD Certification Service. 

1 hour/CPD points

The information, content and materials available in this training are for general information purposes.  Whilst we endeavour to keep the information up to date and correct it is always advisable to check the latest guidance.