The best practice guides are aimed at staff working in clinical research within the NHS, specifically at Newcastle upon Tyne Hospitals NHS Foundation Trust. The various guides have been authored by the staff carrying and supervising such functions and therefore contain links to relevant Standard Operating Procedures, Trust Policies and template documents as well as practical advice on how the materials can be used.

The guides are listed below and you can click the individual Hyperlinks to open a PDF version of the document;

Health Research Authority (HRA) Basics

Good Clinical Practice (GCP)

Clinical Trials Safety Reporting

Site File Management

Responsibilities of Investigators Conducting Research

Sponsorship and Funding

Submission Guidance

Capacity and Capability form guidance

Hosted Amendment Guidance

Research Study Activation and checklist

Pharmacy Clinical Trials

Essential Documents

Radiation Exposures in Clinical Research

Local Portfolio Management System (LPMS) and Recruitment Upload

Principles of CRF completion, source data, data locks and worksheets

Commercial Studies – Costing

Commercial Studies – Feasibility, Site Selection and Communication

Finance: Pre-award

Finance: Raising Invoices

Additional Committees

In addition to the list above, the Document Search Tool on the NJRO website can be filtered by Research ‘Job Role’ to indicate which sections of this document are essential for each group of staff.  As well as the best practice guides, the tool incorporates all NJRO Policies, Standard Operating Procedures, Work Instructions and Templates that have been deemed appropriate for the NuTH research workforce. 

If you have any questions relating to the documents or would like to raise a change request please contact the Newcastle Research Informatics team on who will raise a request on your behalf or contact the relevant document author.