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Your First Application to the GCRC
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DSMP Example: DSMP for a protocol involving liver biopsies
The following Data and Safety Monitoring plan was written by Dr. Maggie Shuhart, for a
protocol involving liver biopsies.
This investigation involves a risk-level III procedure, in a population that should not be at
any increased risk for complications.
Monitoring for adverse events will be conducted real-time by the principle investigator. In
addition, the research nurse coordinator will call patients within 72 hours of the biopsy to
assess for pain and other symptoms indicating possible post-procedure complications. Subjects
are discharged with specific self-monitoring guidelines and instructed to call immediately for
any concerning signs or symptoms.
Adverse event grading and attribution scale
A serious adverse event is defined as either fatal or life-threatening, requires inpatient
hospitalization or prolongation of an existing hospitalization, results in persistent or
significant disability/incapacity, is medically significant or requires intervention to
prevent one or other of the outcomes listed above.
Grading scale for AE intensity:
| Mild: |
Discomfort noticed but no disruption of normal daily activity. |
| Moderate: |
Discomfort sufficient to reduce or affect normal daily activity. |
| Severe: |
Incapacitating with inability to work or perform normal daily activity. |
Attribution scale for AE reporting:
| Probable: |
AE is related to the procedure (liver biopsy), including pain, bleeding, perforation of contiguous organs, infection, and death, if death resulted from one of the aforementioned complications. |
| Possible: |
AE follows the biopsy within a reasonable period (within 7 days), but may have been produced by the subject's clinical state or other factors. |
| Remote: |
AE does not follow the biopsy within a reasonable period (more than 7 days) and could readily have been produced by the subject's clinical state or other factors. |
| Unrelated: |
AE is judged to be clearly due to extraneous causes and does not meet the above criteria. |
AE reporting
Serious AEs will be reported to Human Subjects/IRB, NIH and GCRC no later than 15 days after
the event. Unanticipated events will be reported to the GCRC real time, and to the IRB and
NIH no later than 15 days after the event. Annual reporting of adverse events will be conducted
with the Human Subjects annual review/renewal according to their protocol. These reports will
also be forwarded to the GCRC.
Safety review
Safety review will be conducted by the P.I. on a quarterly basis. The P.I., has extensive
clinical experience with liver biopsies and is well qualified to determine what rate of
severe or unexpected AEs is acceptable. For these reasons, the PI is capable of monitoring
for safety objectively and without bias.
Data monitoring/interim analysis is not necessary/appropriate for this study.
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