.

Useful Documents

Standard Operating Procedures and policies

SOPs are detailed written instructions which are required in order to achieve uniformity of the performance of a specific function.  This section contains all EKHUFT approved SOPs for health-related research and safety reporting. R&I SOPs include:


  •  Post-completion Archiving of Research Study Documents
  • Trial Master Files & Trial Site Files (TMF/TSF)
  • Identification of Research Participants
  • Valid Informed Consent in Research
  • Monitoring Research
  • Non-Compliance in Research
  • Handling and Reporting Urgent Safety Measures for Clinical Trials of Investigational Medicinal Products
  • Serious Adverse Events in Trials where the Trust is a Participating Site
  • Developing a Research Protocol or Proposal
  • Invoicing for Trials
  • Reporting of Serious Breaches in Research and GCP
  • Approval of Grey Area Projects (GAPs)
  • Amendments
  • Confirmation of Trust Capacity and Capability to Host a Research Project

 If you have any questions regarding SOPs used for research in EKHUFT, please contact Jill Baker ( Tel 01227 766877, Ext: 722 5932, email: jillian.baker@nhs.net)

 

Policies

There are a number of policies that govern R&I activities undertaken in EKHUFT. These policies include:

  • Intellectual Property (IP)
  • Production, Review and Approval of Research & Innovation (R&I)
  • Standard Operating procedures (SOPs)
  • Income Distribution from Industry Studies
  • Sponsorship of Investigational Medical Devices trials
  • Policy for Research Management and Governance
  • Research Misconduct and Fraud

All R&I policies & SOPs are uploaded onto the Trust Policy Centre (4Policies) which is accessible to EKHUFT employees. If you cannot access 4Policies, please Jill Baker via email (jillian.baker@nhs.net) who will provide you with the PDF versions.