GCRC #_______
Title:
| Principal Investigator: |
Name; Degree; Department
(Example: Don Brown M.D., Dept of Medicine)
|
Co-Investigators:
|
Name; Degree; Department
(Example: Sally Smith, Ph.D., Dept of Biostatistics)
|
Abstract
Include all the essential elements of the protocol - no more than 250 words.
Note: The Research Plan, A through E, should not exceed 1,500 (approx 5 pages) word limit.
Protocols should be single-spaced, have 1" margins, and contain characters of no less than size 12 font.
- Specific Aims
State the hypothesis and specific aims. List the long-term objectives and what
the proposed research will accomplish. (suggested length: a paragraph or two)
- Background and Significance
Sketch the background leading to this study, evaluate existing knowledge, and
identify gaps, which this study will fill. State the importance of the research
by relating the specific aims to the long-term objectives. (suggested length: ½ page)
- Preliminary Studies/Progress Report
Provide an account of previous studies and/or information that establishes the
experience and competence of the investigator to pursue the protocol. (suggested
length less than ½ page)
- Research Design and Methods
Describe the research design and procedures to be used (what, when, how) on the
GCRC. Provide a flow diagram or timetable. Procedures, situations, or materials
that may be hazardous to personnel and the precautions, should be outlined here.
(suggested length at least 2 pages)
- Statistical Methods (for statistical advice contact
Chris Aston, PhD at 271-4272 ext 42715 or
chris-aston@ouhsc.edu)
Two separate sections are requested.
(suggested length: ½ page)
- Statistical Procedures
Describe specific hypothesis testing techniques and/or estimation procedures
to be employed to address specific aims.
- Power/Sample Size Considerations
Give the rationale and computation to assure that sample size is such that power
for hypothesis test(s) and/or precision for estimate(s) are appropriate for specific
aims.
- Gender/Minority/Pediatric Inclusion for Research
All GCRC protocols must include documentation of the inclusion of women and minorities
in the research protocol.
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- Human Subjects
- Provide number, age range, and health status of the subject population. Identify
criteria for inclusion or exclusion. IF ONE GENDER AND/OR MINORITIES ARE NOT
INCLUDED, INCLUDING CHILDREN (Age up to 21 yrs.), PROVIDE A CLEAR RATIONALE FOR
THEIR EXCLUSION.
- Identify sources of research material in the form of specimens, records or data.
- Describe plans for recruitment and consent procedures to be followed.
- Describe risks and assess likelihood and seriousness.
- Describe procedures for protecting against or minimizing potential risks.
- Describe potential benefits and importance to the subjects and others.
- Discuss why risks are reasonable in relation to benefits.
- Data and Safety Monitoring Plan (contact
Jonelle Wright, PhD, or (405) 271-4272
ext. 42710. All protocols on the GCRC must have a GAC approved Data and Safety
Monitoring Plan developed and on file with the GCRC RSA:
- Adverse event (AE) reporting:
[You need to use your sponsor's adverse event reporting
protocol or in the absence of specific sponsor guidelines include the following.]
Adverse events anticipated in this insert level of
risk from GCRC risk definition guidelines]
risk study that involves [insert a synopsis of testing
and interventions] include [describe adverse
events]. We will monitor for these adverse events by [describe types and frequencies of tests, etc., that
will be used to monitor for adverse events (e.g. vital signs, physical exams,
lab tests, etc.)]. If ever an adverse event occurs, [describe your plan to report adverse events such as
the following] research staff will report such to the Investigator who
will then advise the IRB, the GCRC Research Participant Safety Advisor (Safety
Advisor), and the NIH and/or sponsor as indicated [you need to identify your sponsor or others who you
will report adverse events to]. Unanticipated non-serious adverse events
will be reported within 30 days and serious adverse events will be reported
24 - 48 hours as per OUHSC IRB guidelines. In absence of moderate or serious
adverse events, as is appropriate with [state your
study's risk level] risk studies, reports of study progress will be
submitted to the IRB and the GCRC Advisory Committee (via the Safety Advisor)
for review on an annual basis [or specify more often
if the GAC, Safety Advisor, or IRB require more frequent reports or reviews].
Once reviewed, reported adverse events will be tallied by the GCRC Administrative
Secretary for GCRC reporting purposes.
- Risk minimization: All study procedures will be performed according
to protocol and IRB-approved recruitment/consent procedures and
the enrollment inclusion/exclusion criteria previously listed will be closely
adhered to. Possible risks associated with participating in this study
include [list physical, emotional, socioeconomic,
insurability, or stigmatizing risks in detail just like in your IRB application;
you might be able to copy this from Section E of a PHS398 application or
your IRB application].
Risks associated with [name the test or procedure and then describe all risks; just
like in your PHS 398 or IRB application]. These risks will be minimized by
[list procedures to minimize risk and you may include the following as well], by allowing only well-trained clinical research
staff to perform study procedures and testing according to standard practice, and by making sure study participants clearly understand
study procedures before and during the study protocol.
In addition to the above risks, side effects known to occur with [list
tests and treatments involved in the study] include [list the side effects of each]. The possibility
of these occurring will be minimized by [tell how you will do this].
- Monitoring of Study Implementation and Progress: Periodic assessments
will be performed to assess recruitment and retention of study participants,
data quality, and risk-benefit ratio. The recruitment goal for this study
is [specify how many subjects should be recruited within
how many months]. Data checks will be performed by [describe how the accuracy
of data will be assessed and by whom]. Last, if more information about
the study's risk-benefit ratio becomes available, the investigator will be
responsible for notifying the IRB, sponsor, the GCRC, and study participants,
as indicated.
- Study termination: Criteria for early withdrawal of individuals
from this study are: [list reasons and you may wish
to add the following] and/or a participant's inability or unwillingness
to adhere to study procedures. Criteria for early termination of the study
include [list why you would stop the study completely: high proportion
of serious side effect (list), early significant effect in a specific arm
of the study, etc.]
- Confidentiality: [Include what you wrote in your PHS398 or IRB application
and you may add the following.] Study participants will be assigned
study numbers and specimen samples will be tagged with these numbers before
laboratory analyses are performed. We will not use any identifying information
in data analysis procedures or in research reports.
- Data integrity and security: Data will be organized, managed,
and stored in [list where and how (e.g. lab notebook,
software database, etc.)] by [indicate whom].
Security measures used to protect study data from loss or inappropriate use
will include [list and describe. The GCRC statisticians
and Informatics Director can help you describe how you will assure data integrity
(random quality checks, protection from inadvertent modification or loss,
etc.) and protect the security (provisions for data storage sites and access,
password protect, limited access to data sets, etc.) of your data. You may
also include the following.] Hard copies of clinical information
and data will always be kept in a secured place on the GCRC or in our research
office, and only study team members will be able to access them on an as-needed
basis. Key personnel may not alter the data in any database without specific
cause and approval of the Investigator. Study databases will be password
protected. No data will be sent over the internet unless it is de-identified.
Further measures to ensure data security will be according to the direction
of the GCRC Informatics Director's advice and will adhere to security standards
set by the GCRC, the IRB, and the OUHSC [you can describe
the applicable standards including password protection, de-identification,
etc.].
- GCRC Needs and Requirements
Indicate what GCRC resources are necessary.
- Category (A, B, D) and Total Number of patients:
- Total Number of outpatient visits or inpatient bed days:
- Length of study from start to finish:
- GCRC Nursing requirements: Y N
- GCRC Core lab requirements. Processing: Y N Assays: Y N
- GCRC Metabolic Kitchen/Nutritional requirements: Y N
- Informatics (Computer system data support): always Y
- GCRC Biostatistical Support: always Y
- GCRC Special Populations Unit: Y N
- Ancillary Costs:
- Non-GCRC Financial support for the study: agency, ID number, project period, total Direct Costs (Example:
Lilly, LY123456, 09/01/98 - 08/31/2000, $350,000)
- Literature Cited
List only literature cited within the text. Use NIH format: names of all authors,
title, book or journal, vol, page, year. (suggested
length: no more than 12 references)
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| Version |
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