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Process for Clinical Trial Site Set up, Production of Essential
Documentation and Trial Management
The Leeds Teaching Hospitals NHS Trust and University of Leeds have agreed a Quality Control Policy to ensure continuous improvement in clinical trial conduct and patient care and compliance with statutory requirements.
The following documents and processes are required as part of the Quality Control Policy for all clinical trials of investigational medicinal products (CTIMPs) being sponsored by the LTHT / UoL.
The Investigator is responsible for undertaking the actions highlighted in green
Sponsor Approved Template or Checklist |
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Trial Master File Template |
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Site Master File Template |
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Prior to Trial Commencement |
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Staff Authorisation and Delegation Log Template |
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2 page CV Template |
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Site/PI Suitability Checklist Site Initiation Visit Report |
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Patient ID Log Template |
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During the Trial |
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After the end of Trial
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Clinical Trial Report Template |
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