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I.09 |
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Data and Safety
Monitoring Plans and Boards |
Objective
Data and safety monitoring
plans and data and safety monitoring boards (DSMB) are utilized to
protect the safety of human
subjects and to ensure the continuing validity and scientific merit of clinical
studies. This Policy/Procedure
describes University of Texas Health Science Center at Houston (UTHSC-H)
requirements and processes for utilizing them.
Policy/Procedure
I.
Data
and safety monitoring plans - All
human subjects research which involves moderate or high risks to participants must
have a safety and data monitoring plan that is reviewed and approved by the Committee
for the Protection of Human Subjects (CPHS). The method and degree of monitoring incorporated into the plan
is related to the level of risk, size, and complexity of the proposed research.
Safety and data monitoring plans are submitted by principal investigators (PI)
at the time of protocol submission in iRIS.
II.
Utilization
of DSMBs – Some
studies must have a DSMB; the CPHS makes the final determination if a
DSMB is required. Factors
considered in making this determination are discussed below.
A. Phase IIb, Phase III and Phase IV studies
– Phase
IIb, Phase III and Phase IV studies that involve life-threatening or serious
morbidity require an independent DSMB.. Early trials of high-risk treatments studies and trials in
vulnerable populations may require either a DSMB organized by the Sponsor or a
UTHSC-H appointed DSMB. A DSMB may
not be required if the study risk is low or if the duration of a study is too
short to allow for proper DSMB monitoring.
B. Level
of risk and complexity –
The level of risk and complexity of the proposed research are considered when
determining if a DSMB is required.
Examples of factors that increase risk and complexity include: a large
study population; multiple study sites where it may be difficult to recognize
patterns of problems; highly toxic therapies; dangerous procedures; high
expected rates of morbidity or mortality in the study population; and high
chance of early study termination.
III. Establishing a DSMB – There are multiple ways to
organize a DSMB; these options are discussed below.
A. Sponsor
organized DSMB
– Sponsors may appoint an independent DSMB. Sponsors are expected to provide
the UTHSC-H PI and CPHS copies of the DSMB membership, DSMB charter and DSMB
reports.
B. UTHSC-H
DSMB – PIs may
utilize the institutional DSMB appointed by the Executive Vice President for
Research. The DSMB membership includes
a clinician experienced with the conduct
of clinical trials and one biostatistician, epidemiologist or clinician with
expertise in clinical trial design and analysis. Ad hoc voting members are appointed on an as needed
basis to ensure the Board has the scientific expertise required to effectively
monitor individual studies.
C. Investigator established DSMB – Principal investigators (PIs) may establish
their own DSMB. When establishing a
DSMB, the PI must ensure the members (1) have the appropriate expertise and
include an expert in the field of study and a biostatistician, and (2) complete
the UTHSC-H DSMB Conflicts of Interest Certification to document they have no financial
or professional interests that create or could be perceived to create conflicts
of interest.
III.
PI
Responsibilities
A. PIs submit initial data and safety
monitoring plans in iRIS applications for review/approval by the CPHS. Information submitted in iRIS also
addresses if and how a DSMB will be utilized.
B.
PIs
utilizing an internal DSMB (i.e. institutional or PI established DSMB) submit detailed
data and safety monitoring plans to the Board (UTHSC-H Data and Safety
Monitoring Plan) for review/approval.
C.
PIs
submit to the DSMB (1) serious adverse event reports and (2) summary reports at
least annually (more frequent reporting may be required given the
risk/complexity of individual studies).
D. PIs submit reports from external
DSMBs to the CPHS through iRIS.
IV.
Responsibilities
of Internal DSMBs
A. Internal DSMBs review/approve data
and safety monitoring plans submitted by PIs for individual studies.
B.
Internal
DSMBs review serious adverse event reports and summary reports and makes
recommendations to the PI and CPHS as to whether studies should be continued as approved, changed, or
terminated.
V.
CPHS
Responsibilities
A.
The
CPHS reviews/approves human subjects
protocols and determines if a DSMB is required.
B.
The CPHS reviews/approves
the DSMB plan to ensure protection and safety of human subjects and adequacy of
the plan. In reviewing the plan,
the CPHS considers factors such as the: risk, size, and complexity of the
proposed research; composition and qualifications of the DSMB members; and frequency
of DSMB meetings.
C.
The CPHS reviews the
DSMB reports and determines if studies should be continued as approved,
changed, or terminated.
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Applicable Regulations
and Guidelines NIH policy: http://grants.nih.gov/grants/guide/notice-files/not98-084.html NIH policy: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html
NICHD policy: http://grants.nih.gov/grants/guide/pa-files/PAR-98-084.html NHLBI policy: http://www.nhlbi.nih.gov/funding/policies/dsmb_inst.htm NCI policy: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm GCP Guidance: http://www.fda.cder/guidance/95fnl.pdf
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Updated 8/2/2007, Report
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