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Ann Melvin, MD
Associate Program Director, Research Subject Advocate Program
Office: CHRMC W-7871
Mailstop W-6605
(206) 987-2535
ann.melvin@seattlechildrens.org

DSMP Example: Generic DSMP to meet minimum reporting requirements

Assessment of level of risk: <level of risk>

Oversight for this investigation will be provided by: <person's name>

An adverse event (AE) is any untoward medical occurrence in a subject, not necessarily having a causal relationship with the study. A serious adverse event (SAE) is any untoward medical occurrence that a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent or significant disability/incapacity, or e) is a congenital anomaly/birth defect. AE's may be graded as Mild (no limitation of usual activities), Moderate (some limitation) or Severe (inability to carry out usual activities) and attributed according to the relationship to the study drug and/or procedures as Not related, Unlikely, Possible, Probable, or Definite. SAEs are reported immediately by telephone to the UW IRB and GCRC. An Adverse Event Report form will be completed and returned to the UW IRB and GCRC within 3-7 working days.

Study progress (include what will be reviewed) and adverse events will be reviewed by <person's name> on an X basis.

Annual Reports are submitted to the UW IRB and will contain:

1. The number of adverse events and an explanation of how each event was handled
2. The number of complaints and how each complaint was handled
3. The number of subject withdrawals and an explanation of why the subject withdrew or was withdrawn
4. The number of protocol violations and how each was handled