Download Template Outline Protocol for Proposed Clinical Project

Template Outline Protocol for
Proposed Clinical Project
Template Number:
WFCRC/05/T06/02
Version Number & Date: 2nd Version 25th November 2005
Effective Date:
25th November 2005
Superseded Version Number & Date (if applicable):
Review Date:
25th October 2005 v1
25th November 2006
Revision
Chronology:
Version Number
Effective Date
Reason for Change
WFCRC/05/T06/00 th
9 August 2004
Original
WFCRC
/05/T06/01
25th October 2005
V1
Administrative changes i.e. new
corporate header.
WFCRC
/05/T06/02
25th November
2005
Addition of question on risks with
supply of IMPs
WFCRC/05/T06/02
WANFANG Hospital Clinical Research Centre
Outline Protocol
FINAL 25th November 2005
Page 1 of 7
OUTLINE PROTOCOL FOR PROPOSED CLINICAL PROJECT
For official use:
Date received _______________
ADMINISTRATIVE INFORMATION
Name of CI
Department/location of
CI
Name of applicant if
different to above
Department/location
Sponsor, if known
Proposed Funder
Proposed start date
Proposed end date
PROTOCOL OUTLINE
Full title of project
Short title
Version number and
date of protocol
Subject population
Medical condition or
disease under
investigation
Study/trial design
WFCRC/05/T06/02
WANFANG Hospital Clinical Research Centre
Outline Protocol
FINAL 25th November 2005
Page 2 of 7
Primary objective
Secondary objectives
Primary end point
(to be used for power
calculations)
Secondary end points
Inclusion criteria
-
Exclusion criteria
-
Number of arms in the
study/trial
List the different arms
Will there be equal
numbers of subjects
recruited to each arm?
WFCRC/05/T06/02
WANFANG Hospital Clinical Research Centre
Outline Protocol
FINAL 25th November 2005
Page 3 of 7
Proposed total number
of subjects
Proposed number of
subject per site
Study/trial location(s)
How many such subjects
present each year at the
site(s)?
Statistical analysis –
summary, e.g.
- power
- difference to be
detected in
primary outcome
measure
How will the data be
captured?
How will the data be
entered and managed?
Trials involving drugs, vaccines or diagnoses
List Investigation
Medicinal Product(s)
(IMP(s)? (includes use of
placebo)
Are there any other
medical conditions under
investigation with these
IMP(s)?
Method and route of
administration of IMP(s)
(if applicable)
Dose regimen of IMP(s)
(if applicable)
WFCRC/05/T06/02
WANFANG Hospital Clinical Research Centre
Outline Protocol
FINAL 25th November 2005
Page 4 of 7
How will IMP(s) be
provided for trial?
Will IMP(s) be provided
to subjects after trial
completed?
Maximum duration of
treatment per subject
Provide summary (in layman’s terms 250 words) of potential associated risks for
subjects for proposed project. (Include risk of project intervention, side effects of
any IMPs, risks associated with diagnostic tests, collection of samples, cross
infection etc). Suggest how risks will be minimised and controlled.
WFCRC/05/T06/02
WANFANG Hospital Clinical Research Centre
Outline Protocol
FINAL 25th November 2005
Page 5 of 7
Provide summary (in layman’s terms 250 words) of potential associated risks for
the research team and staff for proposed project. (Include risk of working with
patients with infectious diseases, cross infection etc. use of particular equipment,
radiation hazard, COSHH etc). Suggest how risks will be minimised and controlled.
Provide summary (in layman’s terms 250 words) of potential associated risks for
the research institution for proposed project. (Include risk of lobbying groups
misunderstandings, financial risk, insurance risk, risk of litigation, bad PR, etc.
Suggest how risks will be minimised and controlled.
WFCRC/05/T06/02
WANFANG Hospital Clinical Research Centre
Outline Protocol
FINAL 25th November 2005
Page 6 of 7
For clinical trials involving investigational medicinal products (IMPs), provide
summary of potential risks associated with securing continued supply of IMPs
of certified quality in sufficient quantities to complete the trial. Please
remember to consider shelf lives and duration of your trial.
Your name:
Date outline protocol completed:
WFCRC/05/T06/02
WANFANG Hospital Clinical Research Centre
Outline Protocol
FINAL 25th November 2005
Page 7 of 7