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
- Registration, Application and 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.