NHS Permissions and management of studies taking place at UCLH and/or The Royal Free
Standard Operating Procedures (SOPs)
The following SOPs are for the use of researchers conducting studies at UCLH.
- Definition of Responsibilities
- Informed Consent for Research
- Obtaining NHS permission at UCLH
- Reporting Amendments
- Essential Documents and the Study File (TMF/ISF)
- Study Close Down
- Archiving of Investigator Site File and Pharmacy Site File
- Please note: The following records transfer form should be completed in Word format as per the instructions in the UCLH archiving SOP above.
Guidance Documents for Researchers
The following concise guidance documents are for the use of researchers conducting studies at UCLH.
- Guidance on Archiving - UCLH version
- Guidance on Preparation and Maintenance of a Site File
- Guidance on Reporting Amendments
- Guidance on Research Passports: Process for UCLH R&D issuing Honorary Research Contracts and Letters of Access via the Research Passport Route
- Guidance on Research passports: Process for UCLH R&D issuing NHS to NHS Letter of Access