TraCS DSMB Report – MODERATE & HIGH Risk Clinical Trials
REPORT DATE _______________________________
Study IRB Number:
Study Title:
Principal Investigator:
Name of Person Submitting Form: _______________________________________________
Phone Number and Email Address: ______________________________________________
Review Frequency (circle one): Annual Semi-annual Quarterly Interim Other ________
Data reported as of ____________________ (date)
1. Are there study stopping rules for toxicity in this study?
YES
NO
2. Are there study stopping rules for response in this study?
YES
NO
3. If yes to question 1 or 2, include stopping rule chart and describe any toxicities and their
relationship to established stopping rules. Attach minutes from team meetings in which
toxicities and stopping rules were discussed.
4. Are there subject stopping rules in this study?
YES
NO
5. If yes to question 4, please describe subject stopping rules.
6. Summarize all grade 3 or greater adverse events (if any) to date using protocol defined criteria.
7. Describe any significant safety issues, developments, unexpected toxicities, or concerns that
have arisen since the time of last review.
8. Describe any significant changes to the protocol since the time of last review. Attach an up to
date copy of the IRB application and safety monitoring plan for this protocol.
SECTION I:
Table 1. Indicate enrollment numbers for this trial
Screened
(Consented)
Enrolled
on Trial
Currently
on Trial /
Treatment
Completed
Trial /
Treatment
Did not
Complete Trial
(Drop Outs)a
# Subjects since
last DSMB
review
Total # Subjects
at all sites
Breakdown of
Subjects per site
(use separate
row for ea. site)
a. For any subject that did not complete the trial (dropped out, lost to follow up, etc),
please explain.
TraCS DSMB Report – MODERATE & HIGH Risk Clinical Trials
SECTION II: Subject Specific Data. Please complete tables 2.1 and 2.2
Table 2.1: Listing of Serious Adverse Events and Unexpected Adverse Events to date [List
toxicities grouped per subject; indicate events new since time of last DSMB review by
highlighting in yellow; include treatment group (A, B, or C, etc) if applicable]
Treatment
Group
(if
applicable)
Participant
ID
Days on
intervention
Description
of AE/SAE or
Toxicities
Severity
or
Grade
Onset
Date
Stop
Date
* Relationship: Definite, Possible, Probable, Not Related, Unknown
** Outcome:
Recovered, without treatment
Recovered, with treatment
Still Present, no treatment
Still Present, being treated
Residual effect(s) present – no treatment
Residual effect(s) present- being treated
Subject died
Relationship
to
Intervention*
(Y/N)
Outcome**
Reportable
to IRB
(Y/N)
TraCS DSMB Report – MODERATE & HIGH Risk Clinical Trials
Table 2.2: Listing of All Subjects Consented and On Clinical Trial [List all subjects enrolled
in the study, with treatment group or code if applicable. You may tailor this table to fit the
specific reporting needs of your study. If there are study specific data to be reviewed by the
DSMB, please list in table and add additional columns as necessary.]
Treatment
Group
Code
(if applicable)
Participant
ID
Date
Consented
Tx
Start
Date
Tx
End
Date
Toxicities
or
AE/SAE
(date)
Abnormal
Lab Test
Results (date)
Stop Tx
Early (Y/N)
& reason
Study Specific
Endpoint Data
for DSMB
review
TraCS DSMB Report – MODERATE & HIGH Risk Clinical Trials
SECTION III: Only for clinical trials requiring an Unblinded Review by TraCS DSMB:
1. Have Investigational Pharmacy (IDS) provide TraCS DSMB administrator, Marie
Rape, marie_rape@med.unc.edu with unblinding codes for subjects enrolled on
study intervention to date.
2. If an unblinded statistician involved in the study, complete two tables below:
Table 3.1: Number of Adverse Events by category of severity and treatment arm
(tailor table to fit specific study criteria)
Treatment Arm
Placebo
Treatment
A
Treatment
B
Treatment
C
Total
Total # of Adverse
Events
Severity
Mild
Moderate
Severe
Life Threatening
Trial Related
Discontinued due
to toxicity
Table 3.2: Distribution of Adverse Events by category and treatment arm (tailor
table to fit specific study criteria and AE category or term)
Treatment Arm
AE Category or
Term (i.e., CTCAE)
Pain
Gastrointestinal
Dermatologic/skin
Neurologic
Blood/bone marrow
Infection
Pulmonary
Metabolic/Laboratory
Placebo
Treatment
A
Treatment
B
Treatment
C
Total