Application for the University of Warwick toact as Research Sponsor under the Department of Health’s Research Governance Framework or Medicines for Human Use (Clinical Trials) Regulations 2004

For more information on applying for research Sponsorship at Warwick, please see the R&IS webpages:

For help completing this form, please contact the Research Governance Team, R&IS:, x73961.

Part A: Sponsorship
A1. Proposed sponsorship arrangement / Warwick sole sponsor: ☐(please skip to part B)
Co-Sponsorship: ☐
A2. Details of Co-sponsor / Click here to enter text. /
A3. Contact person for Co-Sponsor / Click here to enter text. /
Part B: Project Details
B1. Project Title / Click here to enter text.
B2. Project acronym (if applicable) / Click here to enter text. /
B3. Type of study
(see webpages for definitions) / ☐ Clinical Trial of an Investigational Medicinal Product (CTIMP)
☐ Clinical investigation or other study of a medical device
☐ Interventional
☐ Non-interventional
B4. Chief Investigator
(Academic Supervisor for student projects) / Click here to enter text.
B5. School/Division / Click here to enter text.
B6. Employment Status with University / Honorary ☐ Substantive ☐
B7. Contact Details / Email: Click here to enter text.
Tel: Click here to enter text.
B8. Student Project / Yes: ☐ No: ☐
B9. Student Details (if applicable) / Name: Click here to enter text.
Course/Qualification: Click here to enter text.
Department: Click here to enter text.
Supervisor: Click here to enter text.
B10. Project duration / Start date: Click here to enter text.
End date: Click here to enter text.
B11. How has the study been peer reviewed? / Funder: ☐
Internal: ☐
Other: ☐ Provide details:Click here to enter text.
B12. Will the study be adopted onto the NIHR portfolio? / Yes: ☐ No: ☐
B13. Co-Applicants / Yes: ☐ No: ☐
Co-applicant 1 / Name: Click here to enter text.
Institution: Click here to enter text.
Co-applicant 2 / Name: Click here to enter text.
Institution:
Co-applicant 3 / Name: Click here to enter text.
Institution:
Co-applicant 4 / Name: Click here to enter text.
Institution:
B14. Please provide a lay summary of the Study: (Max 200 words)
Click here to enter text.
Part C: Funding
C1. Type of funding: / Externally funded: ☐
University funded (e.g. Warwick impact fund) ☐
Own-funded: ☐
Other: ☐ Provide details: Click here to enter text.
C2. Name of funder / Click here to enter text. /
C3. Stage of funding / Application: ☐ Awarded: ☐
C4. Amount of funding awarded/required / Click here to enter text. /
C5. Duration of funding / Click here to enter text. /
C6. Name of Institution receiving the funding / Click here to enter text. /
C7. Have any contracts been agreed for this study? / Click here to enter text. /
Part D: Ethics
D1. Type of ethical review required

/research_integrity/humanparticipants_material_data/ / NHS REC (HRA): ☐ BSREC: ☐ HSSREC: ☐
Other☐ (please specify): Click here to enter text.
D2. Has this project already received favourable ethical opinion? / Yes: ☐ No: ☐ Under review: ☐
D3. Has this project previously received unfavourable opinion from a REC? / Yes: ☐ Provide details: Click here to enter text.
No: ☐
Part E: Sites / Multi-site: ☐ Single Site: ☐
E1. Will any sites be overseas? / Yes: ☐ No: ☐
E2. Type of site(s) (select all that apply) / NHS Trust(s): ☐ GP/CCG(s): ☐ Non NHS site(s):☐
Other: ☐ Please specify: Click here to enter text.
E3. Total number of sites / Click here to enter text. /
E4. Lead Site/NHS Trust / Click here to enter text. /
E5. List of sites (if known) / Click here to enter text. /
E6. Will the CI also be the PI at the site(s)? / Yes: ☐ No: ☐
Click here to enter text.
Part F: Participants
F1. Total number of participants to be recruited / Click here to enter text. /
F2. Type of participant (please select all that apply) / NHS Staff: ☐
NHS patient(s): ☐
Healthy volunteers: ☐
F3. Will the study seek to recruit any of the following individuals / Vulnerable/dependent adults: ☐
Minors (<18 years): ☐
Prisoners/young offenders: ☐
Individuals lacking capacity to consent: ☐
Pregnant Women: ☐
Participants in emergency care setting: ☐
Part G: Data Security & Information Governance
G1. Will this study involve access to any previously collected identifiable data/NHS patient records / Yes: ☐ Please specify: Click here to enter text.
No: ☐
G2. Will this study involve access to any previously collected non-identifiable data/NHS patient records / Yes: ☐ Please specify: Click here to enter text.
No: ☐
G3. Will new data collected during the study be anonymised? / Yes: ☐ Please give details of anonymisation process: Click here to enter text.
No: ☐
G4. What format will data be stored in?
(i.e. password protected computer file or paper) / Click here to enter text. /
G5. Where will data be stored?
(e.g. building, floor, room, computer/cupboard) / Click here to enter text. /
G6. Will data be transferred to another organisation? / Yes: ☐ Please specify: Click here to enter text.
No: ☐
Part H: Insurance
Does this project:
H1. Involve pregnant women / Yes: ☐ No: ☐
H2. Involve children under the age of 5 / Yes: ☐ No: ☐
H3. Involve people who may lack capacity / Yes: ☐ No: ☐
If yes please provide more detail:Click here to enter text.
H4. Include an intervention involving contraception / Yes: ☐ No: ☐
H5. Include any substances that could cause addiction / Yes: ☐ No: ☐
H6. Involve any sites outside the EU / Yes: ☐ No: ☐
If yes please specify:Click here to enter text.
H7. Have a duration of longer than 8 years / Yes: ☐ No: ☐
Part I: Study Management & Organisation
I1. Is this a randomised controlled trial (RCT)? / Yes: ☐ Provide details of randomisation: Click here to enter text.
No: ☐
I2. Will the study be run through Warwick CTU? / Yes: ☐ No: ☐
I3.Will the study be run through another CTU? / Yes: ☐ Provide details: Click here to enter text.
No: ☐
I4. Where will the Trial Master File (TMF)/Study file be kept? / Click here to enter text. /
I5. Who will be responsible for managing the TMF? / Click here to enter text. /
I6. Will oversight be provided by any of the following?
(Please select all that apply) / Trial Management Group: ☐ Trial Steering Committee: ☐ Data Monitoring Committee: ☐
Other: ☐ Please specify: Click here to enter text.
I7. Who will be providing statistics support for the study? / Click here to enter text. /
I8. What arrangements are in place for quality assurance/monitoring of study activities?
(For international studies, please provide information regarding QA arrangements for both international and UK sites) / Click here to enter text. /
Part J: Safety Reporting
J1. What processes are in place for safety reporting? / Click here to enter text. /
Part K: Training
K1. Has the CI undertaken GCP training within the last 2 years? / Yes: ☐ No: ☐
Please provide evidence
K2. Has the CI been on the CI training course? / Yes: ☐ No: ☐ Booked to attend: ☐
Please provide evidence
K3. Has any other relevant training been undertaken by the CI for this trial?
(e.g. taking informed consent from children/young persons, Mental Capacity Act etc.) / Click here to enter text. /
K4. Has the CI undertaken training for working with human samples? / Yes: ☐ No: ☐ Booked to attend: ☐
Please provide evidence
Not working with Human Tissue: ☐
Part L: Human Sample Collection/use
L1. Will additional human samples be collected from participants as part of this project? / Yes: ☐ No: ☐(please skip to part M)
L2. What samples will be taken from participants? / Click here to enter text. /
L3. Approximately how many samples will be collected? / Click here to enter text. /
L4. Will informed consent be taken? / Yes:☐
No: ☐ Provide a reason: Click here to enter text.
L6. Will any samples be collected from the deceased? / Yes: ☐ Provide details: Click here to enter text.
No: ☐
L7. Will the samples be kept for future research? / Yes: ☐ No: ☐
L8. Where will the samples be stored? / Tissue bank: ☐ provide details: Click here to enter text.
CSRL: ☐
UoW: ☐ Provide details: Click here to enter text.
Other: ☐ Provide details: Click here to enter text.
L9. Will samples be transferred between organisations? / Yes: ☐ Provide details: Click here to enter text.
No: ☐
L10. Will any existing samples be used in this research? (e.g. those previously collected as part of another project, in a tissue bank etc.) / Yes:☐ Provide details: Click here to enter text.
No: ☐
Part M: Pharmacy
M1. Does the project involve a drug (including any placebo)? / Yes: ☐ No: ☐ (please skip to part N)
M2. Name of drug(s)
Please list all, including any placebo / Click here to enter text.
M3. Type of use (indication of on or off label) / Click here to enter text.
M4. For the above named medicinal product(s), have you secured any free of charge or at a discount? / Yes:☐ Provide details: Click here to enter text.
No: ☐
M5. Name of intended supplier / Click here to enter text.
M6. Is this a blinded study? / Yes: ☐ No: ☐
M7.Has an emergency code break procedure been established? / Yes: ☐ Provide details: Click here to enter text.
No: ☐
M8. Confirm which Pharmacy has been contacted to discuss project. / Click here to enter text.
Part N: Devices
N1. Does the study involve a device? / Yes:☐
No: ☐ (please skip to part O)
N2. Please give details of device and supplier / Click here to enter text.
N3. Is the Device CE marked? / Yes: ☐ No: ☐
Please provide evidence
N4. Is the device to be used for its marked purpose? / Yes: ☐ No: ☐
If no, please provide details: Click here to enter text.
Part O: Additional information that may be relevant to this application:
Click here to enter text.
Part P: Chief Investigator Declaration:
I confirm that the information provided in this form is accurate to the best of my knowledge.
With this application, I have provided the following:
☐ Protocol
☐ Evidence of peer review
☐ Evidence of funding
☐ Academic CV
☐ Relevant training certificates
(Please note this list of documents is not exhaustive and you will be asked for further information during the approval process)
CI name: / Click here to enter text. /
CI signature: / Click here to enter text. /
Date: / Click here to enter text. /

Please return the completed form to:

The Research Governance Team

Research & Impact Services

University House

V1.0 17 Jan 2017