Download Checklist: Data Safety Plans

Institutional
Review Board
Checklist: Data Safety Plans
Investigators and IRB Reviewers should use the checklist, on page 2, to assure compliance with Nemours policy
HSP-022 Approval Criteria: Data and Safety Monitoring.
Data Safety Monitoring Plan (DSMP). The monitoring procedures described in the research plan to assure the
safety of study participants, protect them from undue risk, and assure that the risks versus benefits are
continually reassessed throughout the study period. A DSMP may range from monitoring conducted by the PI
to an independent DSMB or DMC. NIH Policy for Data and Safety Monitoring 1998.
Review Thinking Points
Consider whether the DSMP (which may be a section in the Research Plan, or a separate document submitted
via IRBNet) addresses the following questions:
 Who will monitor the data?
 What data will be monitored?
 How frequently will data be monitored?
 What analyses will be performed on the data?
 What decision rules (e.g., stopping rules) will be considered?
 Will unexpected harms be detected promptly?
 Will an increased frequency or severity of unexpected harms be detected promptly?
 Will the protocol be stopped once benefits are proven to outweigh harms?
 Will the protocol be stopped once harms are proven to outweigh benefits?
 Is an independent DSMB/DMC required to assure scientific validity and to protect participants? (The
NIH requires an independent DSMB. The FDA does not require independent DSMB’s for clinical trials.)
Reference HSP-022 Approval Criteria: Data and Safety Monitoring and this excerpt from the NIH: Further
Guidance On A Data And Safety Monitoring For Phase I And Phase II Trials and Draft Guidance from the FDA:
Guidance For Clinical Trial Sponsors On The Establishment And Operation Of Clinical Trial Data Monitoring
Committees
The overall elements of the monitoring plan may vary depending on the potential risks, complexity, and nature of
the trial.
In phase I and II trials, a number of factors influence risk. A phase I trial of a new drug or agent may involve
increasing risk, to a small number of participants, as the drug is escalated in dosage. For phase II trials, there is
sometimes information about risks in normal subjects, but risk may be increased as more participants are
involved and the toxicity and outcomes may be confounded by the disease process. In situations involving
potentially high risks or special populations, investigators must consider additional monitoring safeguards.
For many phase I and phase II trials, independent DSMBs may not be necessary or appropriate when the
intervention is low risk. Continuous, close monitoring by the study investigator may be an adequate and
appropriate format for monitoring, with prompt reporting of toxicity to the IRB, FDA and/or NIH. In some
instances, the study investigator or the IRB may determine that an independent individual may be needed for
monitoring. In studies of small numbers of subjects, toxicity may more readily become apparent through close
monitoring of individual patients, while in larger studies risk may better be assessed through statistical
comparisons of treatment groups.
For multisite phase I and II trials, study investigators should organize a central reporting entity that will be
responsible for preparing timely summary reports of adverse events for distribution among sites and the IRBs.
The frequency of the summary reports will depend on the nature of the trials.
Version May 29, 2008
Page 1 of 2
Checklist for Data Safety Plans, continued.
The Checklist items are offered for the reviewer’s consideration. If applicable, the items that have a ‘yes’ or a
‘no’ must be answered ‘yes’ to be approvable. The Reviewer may complete this Checklist or use it as a
reference only.
PI:
Title:
Decision / Review Items
A data safety monitoring plan (DSMP) is required because
the proposed study is:
1. Interventional
And
2. More than minimal risk.
The application includes a DSMP that:
1. Describes how unexpected and / or serious adverse
events will be identified / discovered and
2. Describes how findings will be assessed and reported to
the Sponsor, the IRB, and the FDA, if applicable.
And
3. Is appropriate to the level of risk and duration of the
study.
If this is a multi-site study under the oversight of the Nemours’
PI, the data safety plan describes how data from multiple
sites will be reported and managed.
If the DSMP includes a DSMB or DMC, the application has a
Charter that describes the Board or Committee’s:
Membership, including function and qualifications
Procedures
The DSMB / DMC is composed of experts relevant to the
study and will regularly assess the trial and offer
recommendations to the sponsor concerning its continuation
The relationship of the DSMB/DMC to the study Sponsor is
appropriate. (There do not appear to be any conflicting
interests in the relationship that could bias analysis)
The overall Data Safety Plan is complete and adequate.
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Comments
If applicable, describe modifications required for
approval.
Y
N Comment:
Y
N Comment:
Y
N
NA Comment:
Y
N
NA Comment:
Y
N
NA Comment:
Y
N
NA Comment:
Yes
No
If No, what modifications are required for
approval?