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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.
THERE ARE NEW IRB AND GCRC FORMS. 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 another 30 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. The GCRC Advisory Committee meets
on the first and third Tuesdays of the
month to approve protocols to be done on the GCRC. 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 **NEW** IRB site AND
NEW Forms for their requirements. The GCRC Addendum must ALSO
include the cost sheet and the Safety Monitoring Plan. |
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NEW
GCRC Addendum : The new addendum
is required for ALL protocols submitted after the March
15th, 2005. 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 to the IRB application,
and submit 30 copies directly to
the GCRC, room 3005 APCF (Memorial Hospital - Bedtower) for consideration.
The GCRC Addendum was last updated on 3-15-05.
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 can down load WinZip
from UNC software site. |
DOWNLOAD
NEW Addendum
(self extracting zip file)
separate files:
addendum
cost sheet
assay req
time/event
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Additional
Information regarding the Biostatistics Core |
| OLD
GCRC Addendum : DO NOT SUBMIT THIS
AFTER MAR 15th, 2005. Attach this addendum to the IRB application,
and submit 30 copies directly to
the GCRC, room 3005 APCF (Memorial Hospital - Bedtower) for consideration.
The GCRC Addendum was last updated on 3-15-05.
The GCRC will deliver the appropriate copies to the IRB. |
Please
use the New Form |
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| Education
Certificate: Copy is required to
be on file with the UNC Office of Supported Research (was ORS) database
for ALL PIs and study staff. Office of Supported Research
and IRB sites have links for training. Web and computer based training
is available. |
Link
to
IRB Education Requirements |
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| 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 |
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DOWNLOAD |
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Word Template: for Nursing Time and
Event Schedule sample. |
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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 |
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UNCH Gender and Ethnic Population Data: Useful
in developing target populations that mirror the UNCH population. |
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DOWNLOAD
(Excel) |
| Informatics
Resources : Outlines the Informatics
Core resources available to investigators for grant applications. |
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Long
Version
Short
Version |
| 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 |
|
Info |
| Submission Materials |
#
of Copies Needed |
| IRB Application, Consent/Assent/Parental Consent/Consent Addendums, GCRC Addendum,
Recruitment Materials, etc. |
30 |
| Protocol |
5 |
| Investigators Brochure |
2 |
| Grant |
1 |
Responses
to
Initial
Review
| Memo
Responses: IRB and GCRC documents
in 4 copies (3 for IRB, 1 for GCRC) are submitted to the GCRC.
The GCRC will take the copies to the IRB. Changes must be
highlighted on two copies. |
Go
to IRB Page |
| Submission Materials |
#
of Copies Needed |
| 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. |
4 |
| Sponsors Amendment and/or
Protocol (if needed) |
3 |
| Revised Investigators Brochure
(if needed) |
2 |
*When sending
copies of revised consent forms, submit 4 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).
Documents
for
Amendment
of GCRC Protocol
| IRB
Amendments Page: IRB and GCRC
documents in 4 copies (3 for IRB, 1 for GCRC) are submitted
to the GCRC. The GCRC will take the copies to the IRB. Changes
must be highlighted on two copies. |
Go
to IRB Forms Page |
| Submission Materials |
#
of Copies Needed |
| Summary Memo, Updated IRB
Application, If needed: Revised GCRC Safety Monitoring
Plan, Modified Consent/Assent/Parental Consent/Consent Addendum
Forms*, Recruitment Materials, etc. |
4 |
| Sponsors Amendment and/or
Protocol (if needed) |
3 |
| Revised Investigators Brochure
(if needed) |
2 |
*When sending
copies of revised consent forms, submit 4 copies of revised forms.
Highlight changes on 2 copies of the forms in yellow marker. The
clean copies will be used for processing.
Documents
for
Annual
Renewal of GCRC Protocol
| Education
Certificate: Copy is required to be on file with
the UNC Office of Supported Research database for ALL PIs and
study staff. Web and computer based training is available. |
Link
to
IRB Education Requirements |
| Protocol
Renewal: Submit the IRB forms in
4 copies directly to the GCRC. Hightlight any changes on
two of the copies. Please go to the IRB Renewal page to make sure
you are using the most current forms. The only GCRC forms required
for the Annual Renewal are the cost sheet (if changes are necessary)
and an updated safety monitoring plan. |
Go
to IRB
Forms Page |
| Safety
Monitoring Plans: A safety monitoring plan, updated
to include any changes since the original approval or last renewal,
needs to be submitted. |
INSTRUCTIONS
(doc) |
| Cost
Sheet: If revised since the original approval or
last renewal. |
DOWNLOAD |
| Submission Materials |
#
of Copies Needed |
| Updated IRB Application or
copy of last application, IRB Progress Report, Education Certificate,
Amendments since last renewal, Adverse Event Reports, Clean current
Consent/Assent/Parental Consent/Consent Addendum Forms*, Updated
GCRC Safety Monitoring Plan, If Needed: Updated GCRC Cost
Sheet, Recruitment Materials, etc. |
4 |
| Updated Protocol (if changed) |
3 |
| Updated Investigators Brochure
(if changed) |
2 |
*When sending copies of revised
consent forms, submit 4 copies of revised forms. Highlight changes on
2 copies of the forms in yellow marker. 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).
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Questions or comments
about Protocol Application? Email Wanda
Simmons, 6-5759, GCRC Protocol Coordinator
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