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Welcome to the UNC
School of Medicine DSMB Website
Purpose of the SOM DSMB
The DSMB functions as a committee within the UNC School
of Medicine. The charge to the DSMB is to review clinical
trials to assure patient safety both by evaluating adverse
events (AEs) and by performing interim analyses of both
safety and efficacy.
The DSMB is responsible for reviewing data from clinical
trials approved by the UNC Biomedical IRB. Investigators
with commercially or governmentally sponsored trials will
normally work with their sponsor’s DSMB. In general,
the SOM DSMB will review data from phase III or other trials
posing significant risk to subjects.
The DSMB will review data from the following types of trials,
when review is deemed necessary, by the UNC Biomedical Institutional
Review Board and/or the Principal Investigator (PI).
- Phase III clinical studies (single
site trials where the PI is a UNC School of Medicine faculty
member and for which UNC is the sponsor)
- Phase IV clinical studies (single
site trials where the PI is a UNC School of Medicine faculty
member and for which UNC is the sponsor)
- Selected phase I, I/II, II, and II/III trials
when such review is deemed necessary by the UNC Biomedical
IRB and the Principal Investigator.
Review our charter
Submitting Research for DSMB Review
Please remember to submit early and check our meeting dates
and submission deadlines against your schedule. Make sure
to keep copies for your records. For speediest processing,
please respond as quickly as possible to DSMB questions.
The IRB cannot permit a trial to go forward until all of
the DSMB’s concerns have been satisfied.
Send DSMB materials to the following address:
Attention: Marie Rape
Room 3005 APCF, Main Hospital, CB #7600
or electronically to mzeldin@med.unc.edu
Meeting Dates and Submission Deadlines
The DSMB meets on the 4th Tuesday of each month, excluding
holidays. A complete listing of meeting dates for the current
calendar year is provided below. Review packets submitted
to the DSMB office will be placed on the first open agenda
that is at least 2 weeks after receipt.
Dates for 2008
Submission by:
|
Meeting Date: |
| January 18th |
January 29, 2008 (5th Tues) |
| February 15th |
February 26, 2008 |
| March 14th |
March 25, 2008 |
| April 11th |
April 22, 2008 |
| May 16th |
May 27, 2008 |
| June 13th |
June 24, 2008 |
| July 11th |
July 22, 2008 |
| August 15th |
August 26, 2008 |
| September 12th |
September 23, 2008 |
| October 17th |
October 28, 2008 |
| November 14th |
November 25, 2008 |
| December 5th |
December 15, 2008 (Monday) |
Submitting Research for DSMB Review
Submission Instructions
For Phase III Clinical Trials:
Please submit 8 paper copies OR an electronic version of
the following information:
- A cover letter describing the type of review requested
(interim review, safety review, etc) should be submitted
along with the following information:
- Name and contact information for principal investigator
- Name and contact information for study statistician
- Projected sample size and statistical analysis
information
- Any safety issues or concerns that have arisen
- The complete up to date IRB Application and consent
forms
- Copy of master protocol (including, where applicable,
investigator’s brochure)
- The GCRC Safety
Monitoring Plan to include stopping rules
- All AE and SAE reports to date
- A completed SOM DSMB
Protocol Report Form
- If an oncology trial, submit a copy
of the completed LCCC DSMC form along with the completed
DSMB Protocol Report Form
For Other Trials of Significant Risk or Phase I,
I/II, and II Clinical Trials:
Please submit 6 paper copies OR an electronic version
of the following information:
- A cover letter clearly indicating trial phase and
explaining, with as much detail as possible, why the
IRB referred this trial to the DSMB (or, if the referral
came from elsewhere, from whom and why). Indicated anticipated
areas of concern, unexpected toxicities seen, or both.
Please indicate clearly whether an initial review is
requested (before subjects have been enrolled) or an
interim review is requested (after enrollment has begun,
e.g., because of adverse events).
The following information should also be provided:
- Name and contact information for principal investigator
Name and contact information for study statistician
- Projected sample size and statistical analysis
information
- The complete IRB Application and consent forms
- Copy of master protocol (including, where applicable,
investigator’s brochure)
The GCRC
Safety Monitoring Plan to include stopping rules
All AE and SAE reports to date
- If this is an interim review, any available interim
data, using the SOM DSMB Protocol
Report Form
- If an oncology trial, submit a copy of the completed
LCCC DSMC form along with the completed DSMB Protocol
Report Form.
Contact information for the SOM DSMB Office
Chair: Ross J. Simpson Jr, MD, PhD
Phone: 966-5201
Email: rsimpson@med.unc.edu
Administration: Marie Rape, RN, BSN
Phone: 966-6844
Email: mzeldin@med.unc.edu
If you would like to discuss your research protocol to
decide if the DSMB is an appropriate resource to use, please
contact Marie Rape. A potential meeting between yourself,
Dr. Simpson, and Marie Rape can be arranged to discuss in
more detail the needs of your research protocol and to devise
a plan for monitoring study data.
Helpful Links And Forms
To view the GCRC Safety Monitoring Plan Instructions, please
click here.
To view the GCRC Risk Assessment and Monitoring Guidelines,
please
click here.
SOM
DSMB Protocol Report Form.doc
UNC OHRE - Office of Human
Research Ethics
To view policies and guidelines regarding data and safety
monitoring from the National Institutes of Health, please
link to the following website:
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