Research & Development Website
Process
for Clinical Trial Document Development and Acceptance of Sponsorship by the
Leeds
Teaching Hospitals NHS Trust (LTHT) or University of Leeds (UoL)
To ensure
a quick and efficient process for the planning and approval phase of your CTIMP,
please ensure the following guidance is read and followed. This applies for
all studies being sponsored by the LTHT / UoL irrespective of the origin of
the funding for the trial.
The Investigator is responsible
for undertaking the actions highlighted in green
| |
|
Clinical
Trial Risk Assessment |
|
|
|
| |
|
|
|
|
| |
|
|
|
Documents Checklist |
| |
|
|
|
|
| |
LTHT or Uol accept sponsorship
|
|
|
|
|
| |
|
|
|
|
| |
|
|
|
|
| |
|
|
|
|
| |
Implement Sponsor Review
Comments
|
|
|
The Investigator must incorporate all
protocl and related document amendments, as specified during the Sponsor
Review Process, prior to ethical and regulatory submission |
| |
|
|
|
|
| |
|
|
Sponsor
provides:
1. Authorisation
to apply for CTA Letter
|
|
Documents Checkist |
| |
|
|
|
|
| |
|
 |
Application &
Approval letter (s) to sponsor |
|
|
| |
|
|
|
|
| |
|
|
Application &
Approval letter (s) to sponsor |
|
|
| |
|
|
|
|
| |
|
|
Application &
Approval letter (s) to sponsor |
|
|
| |
|
|
|
|
| |
|
|
|
|
| |
|
|
|
|
| |
|
|
|
Documents Checklist |
| |
|
|
|
|
| |
|
|
|
|
Back
to leedsth.nhs.uk