02 Study Set Up

To describe the processes for setting up and gaining approval to undertake all research, including clinical trials of investigational medicinal products (CTIMPs), at the Salford Royal NHS Foundation Trust. This ensures that each study complies with current legislation and guidance.

03 Sponsorship

The Department of Health’s Research Governance Framework1 requires that all health related research has a formal sponsor.

15 Writing a protocol

The Research Protocol is a short but detailed statement which provides all the information
necessary to replicate the research study.

19 HRC Issue

This Standard Operating Procedure (SOP) describes the process for issuing a HRC within the joint Salford & ReGrouP Office

22 Setting up a commercial clinical trial

To outline the procedures for setting up and gaining approval for commercially sponsored clinical trials conducted within Salford Royal NHS Foundation Trust. This ensures that each study complies with current legislation and guidance.

26 Writing a Patient Information Sheet

This SOP provides guidance for researchers producing Patient Information Sheets.

04 Adverse Event Reporting

This SOP applies to Clinical Trials of Investigational Medicinal Products (CTIMP’s) where Salford Royal NHS Foundation Trust is acting as research sponsor.

05 Informed Consent

This SOP describes the procedure for obtaining Written Informed Consent from a study
subject.

07 Audit SRFT

The purpose of this SOP is to describe the requirements for an audit inspection withinSalford Royal NHS Foundation Trust.

08 ReGroup delegation of duties

To ensure that a clinical study/trial is run safely and effectively it is essential that all staff
are aware of the extent of their involvement and the limits of their authority.

11 Protocol amendments

This SOP describes the procedure for making amendments to protocols, both substantial and minor, to the National Research Ethics Service (NRES) and the Medicines and Healthcare products Regulatory Agency (MHRA).

17 Obtaining a CTA Authorisation SRFT

This SOP describes the process of applying for a Clinical Trial Authorisation (CTA) from the Medicines and Healthcare products Agency.

09 SRHT Data Archiving

To describe the procedure for archiving study documents at the end of a clinical trial and for retaining medical records for the required period.

01 SOP Production and Approval

To provide a procedure for the production, approval, review, revision and filing of Standard Operating Procedures (SOPs).

12 SFHT Project Audit

An audit is an informal and planned process and can take place prior to, during or after the patient recruitment phase.

13 SRFT Project Suspension

Where the R&D Lead (s) has concerns over the conduct of a study/trial for which the Trust is acting as sponsor, it may suspend recruitment to the trial until these concerns have been satisfactorily addressed. The R&D Lead (s) are responsible for assessing the requirement for potential suspension of a project.

16 Study files -  Sponsor files

To describe the establishment of sponsor files for CTIMPs where Salford Royal NHS Foundation Trust is the sponsor.

20 Risk Assessment

Early risk assessment will allow consideration of the suitability of Sponsorship, monitoring and audit and indemnity arrangements for the project.

21 Registration of Project

To describe the process by which projects are registered within the Research and Development Department.

27 Costing industry sponsored studies through the NIHR networks

To support companies, Local Research Networks and R&D staff in negotiatingappropriate costs for industry-sponsored network studies taking place through Salford R&D.

31 Reviewing a model non-commercial agreement

All mNCAs received by the SalfoR&D office must be checked and any alterations agreed before they are sent for signature on behalf of the Trust. This SOP provides a procedure to follow for checking these agreements.

32 Reviewing a model clinical trial agreement

All mCTAs received by the SalfoR&D office must be checked and any alterations agreed before they are sent for signature on behalf of the Trust. This SOP provides a
procedure to follow for checking these agreements.