NHS Standard Operating Procedures and Forms
If you wish to apply for Loughborough University to act as sponsor for your research you should refer to the following standard operating procedures which detail the documentation you will need to submit.
A review of this documentation will be undertaken by the Research Governance Officer Jackie Green. Once the initial review is completed you will be contacted and may be asked to provide further information or clarification. Once the review process is completed you will be issued with an 'in principle' agreement to sponsor letter.
Agreement in principle is subject to the study receiving all relevant approvals and permissions.
- LU SOP 1002 initial review
- LU SOP 1010 Chief Investigator
- LU SOP 1025 Approval Process
- LU SOP 1027 Writing Protocols
- LU SOP 1033 Site Feasibility
Sponsorship Application Forms
- Research Sponsorship Application Form
- Chief Investigators Responsibilities Form
- Study Feasibility Assessment Form
- HRA Protocol Template and Guidance
- HRA Organisation Information and Schedule of Events
During the Study
Please contact the Research Governance Officer Jackie Green if you are making any amendments to your study or in the case of any adverse events.
The following standard operating procedures detail the procedures to be followed during your study.
- LU SOP 1009 Processing and Reporting of Serious Adverse Events, Serious Adverse
- LU SOP 1012 Management and Production of Corrective And Preventative Action plan
- LU SOP 1013 Identifying and Reporting Deviations and Serious Breaches of GCP and
- LU SOP 1015 Management of Essential Documents and Trial Filing
- LU SOP 1016 Procedure in the Event of Non-Compliance
- LU SOP 1018 Process for Sponsor Approval of Amendments or Additions to Documents
- LU SOP 1021 Informed Consent
- LU SOP 1022 Process for Submission of Annual Progress Reports
- LU SOP 1026 Sponsor Approval Process for Amendments
- LU SOP 1029 Urgent Safety Measures
- LU SOP 1030 Creating a Statistical Analysis Plan (SAP)
- LU SOP 1035 Randomisation and Blinding
- LU SOP 1036 Data Management Process
- LU SOP 1039 Case Report Form Production
End of the Study
The following standard operating procedures detail the procedures to be followed at the end of the study.