Wellcome Trust Clinical Research Facility ( Wtcrf)

WTCRF 27/12/2018

WELLCOME TRUST CLINICAL RESEARCH FACILITY ( WTCRF)
AT THE QUEENELIZABETHHOSPITAL (UHB WTCRF) ANDBIRMINGHAM CHILDREN’S HOSPITAL (BCH WTCRF)
Application Form

Dear Applicant

Thank you for applying to undertake research in the Wellcome Clinical Research Facility.

In keeping with its remit, the Wellcome Trust Clinical Research Facility prioritises experimental medicine projects, including clinical trials, that are of high scientific quality and that will result in an excellent academic output. It also strongly supports research that will benefit patients within the NHS, in particular in the host NHS Trusts, and projects with a clear educational output.

The Scientific Advisory Committee (SAC) will review the evidence that your project can deliver on at least one of these aims. It advises the Directors of the WTCRF whether a project should be adopted.

The next pages detail a checklist of information that the SAC requiresin order to undertake this review effectively. Most of this information should be readily available to you from processes you have already completed and in a format you can just attach with small modifications. It is important that you arrange to discuss the operational aspects of the project with one of the managers of the WTCRF.

To enable your application to be considered by the Scientific Advisory Committee please complete the details below and send to Michelle Grinham() if applying to use the UHB WTCRF, and Timothy Barrett ( ) if applying to use the BCH WTCRF.

PLEASE DO NOT SEND PAPER COPIES, USE EMAIL ONLY

If you have any queries, please contact the WTCRF on Tel: 0121 627 2030 or for BCH WTCRF, on Tel: 0121 333 9553 or 333 9267

CRF Number to be added by SAC Secretary
Title of Research:
Short title:
Chief Investigator:
Local lead investigator:
Sponsor:
Funder:
Approximate funding into Birmingham study site (if known):
Approximate funding available to support activity in CRF (if known):
Note that details of funding and costs must be discussed with the WTCRF manager and be agreed before the study can commence but not necessarily before going to the SAC meeting.
REC reference number(if known):
UHB R&D RRK number (if known):
EudraCT number (if known):

Project Type

Phase IPhase IIPhase IIIPhase IVEpidemiologicalObservational

Screening Experimental Medicine  Other (please specify):

Who completed this form?

Name

Contact details

Post

Organisation
Please electronically attach the following documents to the end of this application or insert a box and add your responses below each section

A.Synopsis

This should be about1-2 sides of A4. However, you are welcome to attach a pre-existing synopsis if available. The following issues should be transparent to the SAC:

• Overall purpose - i.e. where is this project leading?
• The hypothesis and / or specific objectives of this project.
• How the patient selection, intervention (if any), measurements, design and analysis will enable the hypothesis to be tested and objectives to be met.

If you attach a synopsis as a separate document, please insert the file name below.

B.How will the project operate?

Please write or attach a brief and concise summary (about half a page A4) addressing the following issues in so far as they are relevant to the design of the study

• What areas of work will take place in the WTCRF? Who is responsible for this?
• What areas of work will take place in UHBFT, BCH or another local NHS Trust? Who is responsible for this?
• What areas of work will take place in the University of Birmingham or another academic institution? Who is responsible for this?
• What areas of work will take place in an external organization e.g. sponsor, contract research organization, external laboratory? Who is responsible for this?
• What equipment and facilities is needed in the WTCRF?
• What are the sources and arrangements for funding?

If you attach a summary as a separate document, please insert the file name below.

C.Explanation by the investigator of the value of the study

Please complete the form below to explain the value of the project for the NHS or the University or yourself.

• A project must have some value to be approved
• Projects are diverse and will be approved for varied reasons
• There is no simple threshold for approval – you don’t have to “tick all boxes”
• A timeline to delivery of academic or clinical benefit is important
• However, some high quality projects may not report for many years, e.g. phase III clinical trials
• This information is the basis for audit of the WTCRF activity

Has your study had independent peer review? / Yes/No
By whom and what was the outcome? (please attach a copy)
Is this an NIHR portfolio research study?
/ Yes/No

What academic output is expected from this project? (e.g., peer reviewed paper(s), presentation, new grant application etc).

What is the probable timeline to the main academic outputs?

Will investigators from University Hospital Birmingham, Birmingham Children’s Hospital or the University of Birmingham be credited on the academic output (please tick)?

• Lead role (e.g., 1st or last author, lead applicant or new grant)
• Associate role ( e.g., author, co-applicant)
• Limited role (e.g., acknowledged)

Who will own the data and academic output?

What value does this project offer to patients in the NHS (e.g. change clinical practice, access to therapeutic agents etc)?

What educational value does this project offer (e.g. research training fellowship, doctoral study, staff training etc)?

Why does this project need to be done in the WTCRF?

D.Attachments

Please attach the following documents (if available) for reference.

• Trial protocol and / or scientific protocol
• Ethics application
• Peer review report

E.Operational report – CRF managers to complete

• Please discuss your study with the managers of the WTCRF before the SAC meeting.
• There is no intention to add to the paperwork burden – many issues can be addressed simply by discussion with the WTRCF manager, others will be documents you will have to have generated anyway
• Not all issues have to be addressed ahead of the SAC meeting
• All operational issues have to be addressed before the project commences in the WTCRF.
• WTCRF manager to attach a brief summary following discussion with the investigators

F. SAC Review form to be completed at or prior to SAC meeting by CRF manager & chairman

Application form F9 -Version 5 31-04-09 Page 1 of 6

Amended by Rachel Hornabrook Approved by DrNeil Steven