LTHT Research Study Capacity and

Capability Assessment Form

A new LTHT wide process for the assessment of capacity and capability (formerly known as CSU approval) of research studies conducted at LTHT will be introduced from the 18th September 2017.

From this date onwards, if you wish to conduct a research study at LTHT involving LTHT patients please complete the attached form and submit to your CSU for review and approval. A completed and fully signed copy of this form must be submitted to LTHT R&I as evidence of CSU confirmation that there is capacity and capability within the CSU to deliver the study safely and effectively, meeting all governance requirements and performance targets. Supplementary CSU specific feasibility paperwork may still be used locally to aid decision making but only this form will be accepted by LTHT R&I as part of the organisational confirmation of capacity and capability process.

·  Part A - must be completed for all research studies

·  Part B - should be completed where applicants require use of LTHT Clinical Research Facility (LCRF) facilities and resources

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PART A (to be completed by all research teams)

Section 1: Study Details

Study Acronym: / Click here to enter text.
Full Study Title: / Click here to enter text.

Reference Numbers:

R&I / IRAS Number / NIHR Portfolio (if applicable)
Click here to enter text. / Click here to enter text. / Click here to enter text.

Chief/Principal Investigator Details:

Name: / Click here to enter text.
Email: / Click here to enter text.
Telephone: / Click here to enter text.
Has the Chief/Principal Investigator acted / Choose Yes or No.
in this capacity for a previous study?
If no, please give details of any / Choose a category.
CI/PI training undertaken:

All new CIs/PIs at LTHT must have completed CRN PI training before their study can be approved. In-house training sessions will be made available to support compliance.

Study Lead Nurse/ Research Fellow Details:

Name / Job title / Email
Click here to enter text. / Click here to enter text. / Click here to enter text.
Click here to enter text. / Click here to enter text. / Click here to enter text.
Click here to enter text. / Click here to enter text. / Click here to enter text.
Click here to enter text. / Click here to enter text. / Click here to enter text.
Predicted Start date: / Click here to enter text.
Duration: / Click here to enter text.
No. of participants to be recruited at this centre: / Click here to enter text.
How will participants be recruited?: / Click here to enter text.
How many patients at LTHT would have / Click here to enter text.
been eligible in the last 12 months?:

Section 2: Study Overview

Chief Investigator Details:

Name: / Click here to enter text.
Lead Centre Location: / Click here to enter text.

Patient and Public Involvement: If PPI involvement has taken place locally, please describe.

Study summary: Please provide a (plain English) summary of your study.

Total planned recruitment nationally/internationally: / Click here to enter text.

Tick all relevant NIHR reporting groups:

Biomedical Research Centre (BRC) ☐

Clinical Research Facility (CRF) ☐

MedTech and In Vitro Diagnostic Cooperative (MIC) ☒

Performance Initiation & Delivery (PID) ☐

Are there specific competencies or training / Choose Yes or No.
requirements for the study team?:
If yes, please specify: / Click here to enter text.

Section 3: Study Type

Please select the most appropriate study type from the following drop downs. All questions are mandatory:

A. / Is the study interventional or non-interventional? / Choose an item.
Interventional studies ONLY:
B1. / What phase is your study? / Choose a category.
If Other selected, please define: / Click here to enter text.
Non-interventional studies ONLY:
B2. / What type is your study? / Choose a category.
If Other selected, please define: / Click here to enter text.
All studies:
C. / Please select the primary intervention/area: / Choose an item.
If Other selected, please define: / Click here to enter text.
D. / Is this study classified as Experimental Medicine? / Choose Yes or No.
E. / Is this study randomised? / Choose Yes or No.
F. / Is this study classified as First in Human? / Choose Yes or No.
G. / Is this study a Clinical Trial of an Investigational / Choose Yes or No.
Medicinal Product (CTIMP), requiring a Clinical
Trials Authorisation (CTA) from the MHRA?
H. / Is this study an Advanced Therapy Investigational / Choose Yes or No.
Medicinal Product (ATIMP)?
I. / Is your study classified as early phase / Choose Yes or No.
(Pilot/Feasibility, Phase 0, I or II)?
J. / Is your study classified as late phase (Phase / Choose Yes or No.
3 or 4) and has a translational aspect?

Section 4: Study Support

Please select the relevant support departments you have already contacted and provide contact information:

Radiology ☐

Name of contact: / Click here to enter name.
Email: / Click here to enter email.

Pharmacy ☐

Name of contact: / Click here to enter name.
Email: / Click here to enter email.

Pathology ☐

Name of contact: / Click here to enter name.
Email: / Click here to enter email.

Other ☐

Please specify department: / Click here to enter text.
Name of contact: / Click here to enter name.
Email: / Click here to enter email.
CTIMP studies: Is there an exit strategy / Choose Yes or No.
in place for the end of the study?

Section 5: Funding Details

Main Funding Organisation

Are you in receipt of funding to support this study? / Choose Yes or No.
Name of main funding organisation: / Choose Yes or No.
Select the category of the main study type: / Choose a category.
If selected DH/NIHR, or Other, please define: / Click here to enter text.
Have you selected “Use of the CRF” in the set-up costs / Choose Yes or No.
section of the commercial study costing template?
Have you applied for NIHR portfolio adoption?: / Choose Yes or No.
If yes, date applied: / Click here to enter a date.
Number (if known/assigned): / Click here to enter text.
Are any research fellowships, Masters or PhD / Choose Yes or No.
students attached to or supported by the study?

NOTE: If yes, University of Leeds honorary contracts and GCP training are required prior to commencement of the study.

Grant Administrating Organisation (if applicable, please state for academic studies)

Which body will provide the research grant? / Click here to enter text.
Which organisation will administer / Choose an organisation.
the research grant?

Sponsor

Which organisation will be acting as / Click here to enter text.
the research governance sponsor?
Has research governance sponsorship been confirmed? / Click here to enter text.

Account Holder

The account for the study will be held at: / Choose an item.
If Other, please give details: / Click here to enter text.

CSU Signature

CI/PI Name (print): / Date:
CI/PI Signature:
Outcome of review: Agreed ☐ Provisional ☐ Rejected ☐
Details if Provisional or Rejected:
Name of CSU Approved Signatory (print) / Date:
CSU Signature:

If your study is early phase or late phase with a translational aspect (see Section 3, Questions I and J), it may qualify to be supported by the Leeds Clinical Research Facility. If so, please complete PART B:

PART B (to be completed if LCRF support is to be requested)

Section 6: Site Specific Information

Please tick which site facilities you wish to use:

Bexley (SJUH) ☐ / Jubilee (LGI) ☐ / Chapel Allerton ☐
Dental (DenTRU) ☐ / Clarendon Wing (Paeds) ☐

Please tick which LCRF services/ facilities you would like to use:

ECG ☐ / Inpatient monitoring ☐ / Blood testing/ sampling ☐
Patient monitoring ☐ / Cardiac ultrasound ☐ / Cardiac monitoring ☐
Drug infusion ☐ / ETT/ CPEX ☐
Other (please specify) ☐
Click here to enter text.
Intensity of study (Please see Appendix A / Choose an item.
for instructions on how to assess):
Risk of study (Please see Appendix B / Choose an item.
for instructions on how to assess):

Please outline any other issues that may impact on capacity and capability:

Describe any safety aspects that LCRF staff need to be aware of (e.g. adverse drug reactions, risk to patients from procedures, etc.)

Publication Guidelines & Acknowledgement

Work undertaken in the LCRF should be acknowledged in all publications and press releases. This includes work that is funded through any charity or grant funding source and not merely that directly funded by NIHR.

If any person or organisation involved in the study wants to publish a press release regarding work to be published, the NIHR Clinical Commissioning Facility (CCF) must be sent a copy of the manuscript 28 days before publication (see LCRF Hub Team for guidance).

Please tick here to acknowledge you have read and agreed to these guidelines: ☐

Section 7: Approvals and Signatures

CI/PI Name (print): / Date:
CI/PI Signature:
Outcome of review: Agreed ☐ Provisional ☐ Rejected ☐
Details if Provisional or Rejected:
Name of CRF Approved Signatory (print): / Date:
Review Signature:

LCRF Contact Details

Email:

Telephone: 0113 20 60474

Address: Leeds Clinical Research Facility, First Floor, Research & Innovation Centre, St. James’s University Hospital, Beckett Street, Leeds, West Yorkshire, LS9 7TF

Appendix A: Assessing the Intensity of Your Study

Please read the handbook carefully and complete the spreadsheet. This spreadsheet may take an hour or more for complex studies.

Please submit the completed Intensity Spread Sheet with your completed Capacity & Capability Assessment and Application Form.

Handbook for completing the Intensity Tool Spread Sheet /
Intensity Tool Spread Sheet /

Appendix B: Assessing the Risk of Your Study

Please read the instructions and use the tool to assess the risk of your study.

Instructions for Assessing Risk /
Risk Assessment Tool /

Version 1.0, 01/09/2017, LTHT Research & Innovation

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