Data and Safety Monitoring Committee (DSMC)
Annual Renewal Form
Investigator-Initiated Studies without a DSMB
Protocol #:
Date form completed:
Protocol Title:
Principal Investigator:
The information provided in this form should be in accordance with the
Data and Safety Monitoring Plan written in the protocol.
Submit completed form and attachments to Clinical Research Support at submissions@fredhutch.org
Submission due date:
A. Dose Escalation:
Dose Escalation (or multi dose level) definition: For each subject to date, provide cohort and dose assignment.
Add rows to table as needed so that each subject enrolled to date is displayed (Attachments in the following format are acceptable)
If a subject experienced a dose modification per protocol, indicate dose modification.
If this is a single dose level study state “not applicable” in the first subject line and skip this table.
Subject #
Cohort
Study Drug Dose Level/Modification
B. Dose Limiting Toxicities (DLT) (as per protocol):
Dose limiting toxicity (DLT)
definition: Provide the
definition of DLT as written in
the protocol.
If protocol does not define
DLTs, note “not applicable” and
skip this table.
Total # of Patients at dose
level
Dose Level
Total # of Patients
Experienced DLT
Identify DLTs:
01312 DSMC Annual Renewal Form
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Version: 07/28/2015
Data and Safety Monitoring Committee (DSMC)
Annual Renewal Form
Investigator-Initiated Studies without a DSMB
C. Stopping Rules (as per protocol):
Stopping rules: Provide the
stopping rules as written in the
protocol.
If protocol does not have
stopping rules, note “not
applicable” and skip this table.
How are stopping rules
followed?
Stopping rule(s) per patient
Have any stopping rules been
met?
Yes
Stopping rule(s) per event
No
Stopping rule:
# of Patients/Events met
Stopping Rule
Identify events that count
toward stopping rule:
D. Were there any premature terminations from study due to toxicity not otherwise listed in this form?
Yes
No
If yes, please describe.
If no, note “not applicable” and
skip this table.
E. Adverse Events:
If there are no Adverse Events being reported, please provide explanation:
If there are Adverse Events to report, provide cumulative tabulation of adverse events by type and grade as described in the data
and safety monitoring plan outlined in your protocol. Examples of Adverse Event tables are below.
 Events must be reported in tabular format
 Report must include the category; toxicity; grade and number of events
 For multicenter studies where the Cancer Consortium is not the coordinating center, report only local events.
 For multicenter studies where the Cancer Consortium is the coordinating center, report study wide events.
 Include Grade 5 events for reporting number of deaths on study.
01312 DSMC Annual Renewal Form
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Version: 07/28/2015
Data and Safety Monitoring Committee (DSMC)
Annual Renewal Form
Investigator-Initiated Studies without a DSMB
Examples of Adverse Event Tables
Example Table 1:
Adverse Events
Category (CTCAE)
Gastrointestinal Disorders
Gastrointestinal Disorders
Vascular disorders
Example Table 2:
Adverse Event/Toxicity
1
N
Nausea
Pancreatitis
Hypertension
Grade and Number (N) of events
2
3
4
5
N
N
N
N
1
1
1
Adverse Events
Category
Gastrointestinal Disorders
Gastrointestinal Disorders
Vascular Disorders
01312 DSMC Annual Renewal Form
CTC Term
Nausea
Pancreatitis
Hypertension
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Grade
Number of Events
3
4
2
8
1
4
Maximum
Attribution
Unlikely
Possibly
Unrelated
Version: 07/28/2015