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Chief Investigator:

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1.0. CLINICAL TRIAL INFORMATION
1.1. Full title of proposed trial (including acronym):
1.2. Phase of clinical trial (I-IV): / Phase I Phase I/IIa Phase II
Phase III Phase IV
1.3. Trial design: / Open label Placebo Controlled Blinded Cross over
Randomised – Number of trial arms:
Other:
1.4. Target patient population: / Adult health volunteer Adult patient
Children, please indicate age range:
Patients who lack capacity Patients in emergency situations
Pregnant or nursing women
1.5. Primary objective:
1.6. Secondary objective(s):
1.7. Number of participants (total):
1.8. Planned study duration: / Planned start date: Planned end date:
2.0. CHIEF INVESTIGATOR (CI) INFORMATION
2.1. CI details: / Name:
Address:
Email address:
Telephone number:
2.2. Employing institution and any honorary appointments:
2.3. Details of most recent GCP training: / Date of training:
Name of provider:
2.4. Number of CTIMPs where the investigator has been PI: / Number of trials:
Phase of trials:
2.5. Number of studies where the investigator has been CI: / Number of trials:
Phase of trials:
Maximum number of sites:
2.6. CI’s experience of the IMP(s) including handling, administration and knowledge of safety profile: / Name of IMP:
No experience Limited experience (<25) Experienced (>25)
Name of IMP:
No experience Limited experience (<25) Experienced (>25)
3.0. RESEARCH SITE(S)
3.1. Number of sites involved:
3.2. Trust sites involved: / RVI FRH CAV Dental School
3.3. NUTH FT departments involved: / Pharmacy Radiology Laboratories
Medical Physics Enter Department
3.4. Have any of these departments been contacted? / Yes No
If yes please confirm who from that department was contacted:
Department: Name of contact:
3.5. Any modifications required to accommodate study? / Yes No
If yes, please provide details:
4.0. FUNDING
4.1. Has the trial already been costed? / Yes No
If yes please include copy of costing on submission of this form
4.2. Has funding already been secured? / Yes No
If yes please include details of funding received and a breakdown of the funding. If funding administered through Newcastle University please provide BH number.
4.3. Proposed funder details: / Name:
Status: Confirmed Awaiting response
Funding application deadline:
Name:
Status: Confirmed Awaiting response
Funding application deadline:
5.0. IMP INFORMATION
5.1. IMP details: / Name:
Dose:
Route of administration:
5.2. Does the IMP have a Marketing Authorisation within the UK or EEA? / Yes
No (please go to question 5.4.)
5.3. IMPs with Marketing Authorisations: / IMP to be used for its licensed indication as per the SmPC?
Yes No
If no please provide details:
IMP to be used within the patient population specified in the SmPC?
Yes No
If no please provide details:
Is further manufacture required? (e.g. over encapsulation, radiolabelling etc)
Yes No
If yes please provide details:
5.4. IMPs without Marketing Authorisations: / Name of active substance:
Pharmaceutical form: Tablet Capsule Lyophilised powder
Infusion Topical cream
Other, please provide details:
5.5. Can the IMP be classified as: / Biological or biotechnological product Yes No
Advanced Therapy Medicinal Product (ATMP) Yes No
A Genetically Modified Organism (GMO) Yes No
Consisting of tissues or cells Yes No
5.6. How will the IMP be stored: / Is this as per the SmPC? Yes No
6.0. MANAGEMENT & MONITORING
6.1. Has a UKCRC registered Clinical Trials Unit (CTU) been approached to manage the study: / Yes No
If yes please provide details:
Please note that it is a requirement of NUTH FT sponsorship that the trial is managed and monitored by a UKCRC CTU.
6.2. Has a management and monitoring plan drafted? / Yes No If yes please submit a copy with this form.
7.0. FURTHER INFORMATION
Please add further information here:
(out of hours requirements, treatment blinding, arrangements for vulnerable adults/children)

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Name of person completing form: / Job title:
Signature: / Date: dd-mmm-yy

Please attach a copy of your CV and a copy of the draft protocol/proposal.

CTIMP Sponsorship Request Form; version 1.0 – dated August 2013