University of Aberdeen NHS Grampian
Version 1 22-8-15
University of Aberdeen – NHS Grampian Internally Funded Studies:
Sponsorship Registration Form
Study Title:
Chief Investigator:
Internal Reference
Ethics Reference
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Eudract (if CTIMP)
For ease in completing form double click on check box required and change
default value to CHECK.
A. FUNDING DETAILS
A1
For Internal Use
Please provide details of internal funding e.g. discretionary account,
clinical colleagues endowment.
NB this is to ensure correct reporting of participant figures to the
CSO.
Name of source:
..…………………………………………….
Award code (if applicable): .……………………………………………..
B. STUDY DETAILS
B1
Are you the Chief Investigator (CI) of this Study? If no, please provide
your name.
YES
B2
NO, Name: ……………………………………………..
Please confirm CI substantive employer.
NHS Grampian
University of Aberdeen
B3
Other please specify: ……………………………………
Has anyone who is not employed by CI substantive employer had
significant input into the design of the protocol?
NO
B4
YES, please provide details: ………………………………….
Has the study been independently peer reviewed? Please send a copy of
the peer review to the Research Governance Manager: this must be
received before Sponsorship can be confirmed.
NB. a proforma template can be supplied by the Research
Governance Manager if required.
NO
B5
YES, please provide details: …………………………………..
Is this a supervised research study e.g. undergraduate or postgraduate
degree study? If yes, please provide the name of student, supervisor(s)
and level of student.
Student:
……………………………..
Level of Degree:
……………………………..
Clinical Supervisor (if applicable): …………………………….
Primary Academic Supervisor:
……………………………..
TMP-QA-7 Sponsorship Registration Form (Internally Funded)
For Internal Use
University of Aberdeen NHS Grampian
Version 1 22-8-15
B7
Accommodation and Services: Does the study require additional
resources e.g. additional power requirements, data storage, alteration
of accommodation or facilities, centralised University facilities, NHS
Support Departments (labs, pharmacy, radiology, pathology). If yes, has
the study been discussed with the relevant managers?
NO
YES, please provide details: …………………………………..
B8
Is this a multi centre study or single site study? For multi centre
studies please name all sites (where these are known).
Single Site
B9
Multi-site
Site 1: ………………………. Site 2:………………………. etc
Is the study receiving any commercial investment? (this could include
cash funding, in kind contribution & supply of drugs/devices free of
charge).
NO
B10
YES, please give details: ………………………………….
Has the CI undergone GCP training? If yes, please confirm when.
For CTIMP Studies: Have both CI and members of the research team
undergone GCP training? If yes, please confirm when for each research
team member.
N.B. If NO, to prevent possibly delays in R&D permission course
information & contact details for further information are
available via the R&D website.
NO (see above)
B11
YES, please confirm date: ………………………………..
For University CIs: has the study been discussed with the Programme
Leader and Head of School and/or Head of Division? If yes please
confirm who the study has been discussed with.
NO
YES, please give details: ………………………………….
Not applicable as CI substantive employer NHS Grampian.
C. REGULATORY REQUIREMENTS
C1 Is ethical committee approval required to undertake this study? Please
specify which committee will review the study e.g. NHS ethics
committee, College Ethics Review Board, RINH Human Studies
Management Committee, Psychology Ethics Committee
NO
YES, please confirm which committee: ……………………….
C2
Do you require a clinical trial authorisation (CTA) from the MHRA or
approval from another regulatory body to undertake the study? If you
are unsure please contact MHRA for clarification. The MHRA have
published an algorithm to help determine whether a study requires a
Clinical Trial Authorisation, you can access the algorithm through here.
IF YOUR STUDY REQUIRES A CTA PLEASE SEND A COPY
OF THE CTA APPLICATION TO THE RESEARCH
TMP-QA-7 Sponsorship Registration Form (Internally Funded)
For Internal Use
University of Aberdeen NHS Grampian
Version 1 22-8-15
GOVERNANCE MANAGER FOR REVIEW, BEFORE IT IS
SUBMITTED TO THE MHRA,.
YES
C3
NO
Does the study involve a clinical intervention using a medicinal
product*, device or procedure outside the product licence?
*medicinal product: substances or combinations of substances which
either prevent or treat disease in human beings or are administered to
human beings with a view to making a medical diagnosis or to restore,
correct or modify physiological functions in humans.
YES
NO
If YES Have you also contacted pharmacy?
C4
UNSURE
UNSURE
YES
NO
Does your study involve looking into the properties of medicinal
product(s) with the object of ascertaining the safety and/or efficacy of
those products, e.g. Clinical, Pharmacological, Pharmacodynamic
effects, Adverse Reactions, Absorption, Distribution, Metabolism and
Excretion of the product?
YES
NO
UNSURE
D. SAFETY: COMPLETION OF THIS SECTION WILL HELP
DETERMINATION OF THE INDEMNITY ARRANGMENTS
FOR YOUR STUDY
D1
D2
D3
D4
Are there any safety issues the University/NHS Grampian should be
aware of?
NO
YES. Please specify: …………………………………………..
How many participants do you anticipate will be recruited to the study?
For multi-site studies please specify per site.
Will the study involve the use of a drug, medical device or equipment
designed and manufactured by the University or NHS Grampian?
NO
YES. Please specify: ……………………………………………..
Will the study involve any of the following?
Pregnant Women
Children Under 16
NO
NO
YES
YES
Contraceptives or the process of
Genetic Engineering
contraception
NO
NO
YES
YES
Participants with HIV
Participants with Hepatitis
NO
NO
YES
YES
Participants with HTLV1
Participants from outside the UK
NO
NO
YES
YES
TMP-QA-7 Sponsorship Registration Form (Internally Funded)
For Internal Use
University of Aberdeen NHS Grampian
Version 1 22-8-15
D5
Participants with fungal infections
NO
YES
Does any equipment, to be used in the study, which is not owned by the
University of Aberdeen or NHS Grampian have adequate insurance in
place?
NO
YES
UNSURE
Not applicable, all equipment owned by UoA or NHS G.
TMP-QA-7 Sponsorship Registration Form (Internally Funded)