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Investigator Central
How to do Research on the GCRC
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Click here to go to the Official
UNIVERSITY IRB Web Page. The UNC
IRB has oversite responsibility for the protection
of the patients rights for all studies done
on the GCRC. There are very important announcements
about the research process on their page.
STOP!! Call Wanda,
6-5759 FIRST
If you will please call Wanda, you can save
yourself enormous amounts of time because you
won't have to redo everything and make more
copies. Use the IRB application and add to that
the GCRC information from the current protoadd.doc
at the link below. The section starts with USE
OF THE GENERAL CLINICAL RESEARCH CENTER. The
cost sheet is required and is included in protoadd.doc.
Along with the 5 paper copies, provide a CD
that includes all materials. Each file on the
CD, should be identified with the study number
and document type, such as 2499_consent.doc
or 2499irb.pdf. PDF format is preferred, but
a Word or Excel document is acceptable. Be sure
to label the CD with the study number, PI's
name, and the study coordinator's name and phone
number.
The GCRC Advisory Committee meets on the first
and third Tuesdays of the month to approve
protocols to be done on the GCRC. Please check
the meeting dates to see the deadlines for submission.
Intermal review must be done prior to the committee
meeting by staff and the primary reviewer. In
order to have ample time to review
and resolve
concerns, protocols must be received by 12:00
(noon) of the deadline date in the GCRC office,
in order to be reviewed at the committee meeting.
In unusual circumstances, an exemption to the
submission deadlines may be granted allowing
expedited review. As of 1/1/06, such an exemption
requires approval by Dr. Watkins (pbwatkins@med.unc.edu).
Upon approval by the Advisory Committee, the
IRB will include the protocol on the next available
agenda.
With Internet Explorer, you may need to right
click on the download buttons and select "save target as ...".
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Pick
your action:
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Documents
For
New
GCRC Protocol Application
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REQUIRED |
AS NEEDED |
| GCRC
Application is comprised of the completeIRB Application,
and the GCRC Addendum. See the IRB
site for their requirements. The GCRC Addendum
must ALSO include the cost sheet and the Safety Monitoring
Plan. |
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GCRC Addendum : This
download is a zip file that includes the GCRC Addendum,
Cost Sheet, BAC Lab Assay Planner, and the Time
and Events Schedule. Attach this addendum, with
cost sheet and safety monitoring plan, to the IRB
application. All materials need to be submitted
to the GCRC first. This includes new submissions,
responses to IRB/GCRC letters, renewals and modifications.
ADVERSE EVENT REPORTS SHOULD BE SENT DIRECTLY TO
THE IRB. Submit 5
paper copies and an electronic copy of all pertinent
documents directly to the GCRC, room 3005 APCF (Memorial
Hospital - Bedtower) for consideration. Copies will
be forwarded to the IRB. Besides the application
/ addendum, include cost sheet, consent form(s),
master protocol, and investigator brochure. Adobe
PDF is the preferred format, but Word or Excel is
acceptable.. The GCRC Addendum was last updated
on 7-13-06. The GCRC will
deliver the appropriate copies to the IRB.
The new addendum is composed
of several files that are zipped together for easier
downloading. You'll need your ONYEN to down load
WinZip
from UNC software site.
NOTE:
Investigational Drug Service form location has changed:
http://intranet.unchealthcare.org/site/w3/pharmacy/services/investdrugs/requestservice.pdf
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DOWN LOAD
Addendum
(self extracting zip file)
separate files:
addendum
cost sheet
assay req
time/event
IDS cost sheet
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Additional
Information
regarding the Biostatistics Core |
| Safety
Monitoring Plan: Studies
must provide a Safety Monitoring Plan which addresses
safety tests, adverse events, and analysis of adverse
events, etc. Click on the following link to see
the Safety Monitoring Plan instructions provided
in the GCRC application. Updated
3-1-05. |
DOWNLOAD
FORM
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Nursing Time and Event Schedule: Use
this to specify all the patient specific procedures
of the study. (word template) |
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DOWNLOAD |
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Data Management Checklist: Lists
the different aspects of a complete data management
plan. The Informatics Core will complete this form
during your initial interview with them. Although,
it is not required to be submitted with the addendum,
it serves as a solid foundation for planning the data
management section of your study. Updated
12-19-02. |
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DOWNLOAD |
| Data
Planning / Time Line: Use
this to completely specify and organize your
data. Use the first page to define the data
itself. Use the second page to define the time point
relationship to the procedures, questionaires, and
lab tests. A thorough draft will greatly improve
our support of your study. Updated
12-19-02. |
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DOWNLOAD |
| Radiation
Safety Form for Dexa: Form
must be completed and sent to Radiation Safety Committee
for using the Dexa Scan. The form is partially filled
out with standard GCRC information. |
DOWNLOAD |
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| Radiation
Safety Form for pQCT: Form
must be completed and sent to Radiation Safety Committee
for using the pQCT Scan. The form is partially filled
out with standard GCRC information. |
DOWNLOAD |
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| Corelab
(Bioanalytical) : Spreadsheet
to help you identify costs and quantities of assays
to be run. Some assays may be paid for by the GCRC.
Email the spreadsheet to david_barrow@dentistry.unc.edu. |
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Assay
Request / Price Sheet |
| GCRC
Investigators' Lab : Lab
space available on the GCRC after training and coordination
with david_barrow@dentistry.unc.edu. |
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GCRC
Required
Training |
| General
Information about GCRC resources available |
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Info |
| Informatics
Resources : Outlines
the Informatics Core resources available to investigators
for grant applications. |
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Long
Version
Short
Version |
| Submission Materials |
#
of Copies Needed |
| IRB Application, Consent/Assent/Parental Consent/Consent Addendums, GCRC Addendum,
Recruitment Materials, etc. |
5
+ an electronic copy |
| Protocol |
5 |
| Investigators Brochure |
2 |
| Grant |
1 |
Initial
Review, Modifications, Annual Renewals
Memo
Responses:
All materials need to be submitted to the
GCRC first. This includes new submissions,
responses to IRB/GCRC letters, renewals and
modifications. ADVERSE
EVENT REPORTS SHOULD BE SENT DIRECTLY TO THE
IRB.
Please
refer to the IRB website or memo to determine
the number of copies that they require for
your particular action/study, and then add
one more copy for the GCRC. Please
collate the materials into complete sets.
The GCRC will take the copies to the IRB.
Changes must be highlighted on two copies. |
Go
to IRB Page |
| Submission Materials |
TYPICAL
# of Copies Needed
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| Memos responding to GCRC issues
and IRB issues, Updated IRB Application, If needed:
Revised GCRC Safety Monitoring Plan, Modified Consent/Assent/Parental
Consent/Consent Addendum Forms*, Recruitment Materials,
etc. |
3 |
| Sponsors Amendment and/or
Protocol (if needed) |
2 |
| Revised Investigators Brochure
(if needed) |
2 |
*When sending
copies of revised consent forms, submit 3 copies of
revised forms. Highlight changes on 2 copies of the
forms in yellow highlighter. The clean copies will
be used for processing.
Don't Forget!! Cite The GRANT!!
"Supported in part by a grant (RR00046) from the General Clinical
Research Centers program of the Division of Research Resources, National
Institutes of Health."
(just copy and paste this statement).
Don't Forget!! Cite The GRANT!!
"Supported in part by a grant
(RR00046) from the General Clinical Research Centers program of
the Division of Research Resources, National Institutes of Health."
(just copy and paste this statement).
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This
page was last updated:
July 3, 2008 9:43 AM
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