TVCTU –Support Request Form

Once you have completed the proforma, please email it to
The TVCTU Steering Committee will review your request and a member of the CTU team will contact you as soon as possible.
Study Details
Chief Investigator; name and contact details
Name of study
Funding body and stage (e.g. HTA, outline/full)
Sponsor
Application deadline
Total value of funding being applied for
Study Summary
Study hypothesis
Design
Is the study randomised?
Nature of intervention if applicable
Details of control or comparator intervention if applicable
Patient group
Primary Objective
Primary Outcome Measure
Secondary Objective/s
Secondary Outcome Measure/s
Sample size
Number and type of recruitment sites e.g.: community, secondary care clinic, primary care, out of hours
How many months do you estimate patient recruitment will take
Number and nature of patient follow-ups e.g.: face to face at month 2, blood and data collected
Collaborators and external support
Has RDS being consulted? / Yes/No
If yes please provide details of any advice given.
Has a discussion taken place with a potential sponsor
Is the clinical research network or other NHS representatives aware of the study?
Have any discussions taken place regarding NHS treatment costs, excess treatment costs or service support costs?
Is the study a collaboration if so with whom?
Other specialist support needed e.g.: health economist, laboratory services etc.

The TVCTU can offer expert input into:

  • Trial Design; support for funding application submission, sample size calculation, costings and protocol development.
  • Trial Management; ensuring your trial is delivered on time and on budget.
  • Data Management; providing IT solutions for clinical databases and randomisation.
  • Analysis; expert statisticians will provide support throughout the trial conducting both interim and final analysis as required and contributing to final study reports and publications.
  • Quality Assurance and Pharmacovigilance; including submission of CTA to the regulatory authority, site and central monitoring.
  • Contact with the Clinical Research Network
  • Contact with the Research Design Service
  • Contact with the Sponsor’s team
  • Contact with other specialist services

For internal use only

CTU reference: Review date deadline:

Date received: Date acknowledged:

Review outcome: Date notified of outcome:

Reviewed by: