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DSMP Example: DSMP for a protocol measuring sputum concentrations of a non-investigational agent
This is a risk-level I investigation involving sputum collection in children.
Oversight for this study will be provided by the Principle Investigator, Dr. X, with delegation
of responsibilities to designated study personnel. They will ensure all entry criteria are met
prior to the initiation of the protocol and all study procedures and reporting of adverse
events are performed according to the IRB and SAC-approved protocol.
All adverse events related to the study procedures will be fully documented on the appropriate
case report form(s) and entered in a study database. For each adverse event, the investigator
will provide the onset, duration, intensity, treatment required, and outcome, including
documentation of need for premature termination of the SI procedure. Anticipated adverse
events related to sputum induction include wheeze, cough, dyspnea, decreased oxygen saturation,
and drop in peak flow or FEV 1.
Adverse event grading scale:
| Mild |
Persistent mild cough, wheezing, or dyspnea following sputum induction (SI) procedure
without drop in FEV 1 to < 90% of baseline
post-albuterol value that resolves prior to the end of the study visit and does not
require intervention (i.e., bronchodilator therapy) per the judgment of the
investigator.
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| Moderate |
- Drop in FEV 1 following SI procedure to less than 90% of baseline post-albuterol value that responds to albuterol within a maximum of two treatments.
- Oxygen saturation decrease to < 88% for 5 - 10 minutes following the SI procedure.
- Wheezing or dyspnea requiring intervention in the opinion of the investigator.
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| Severe |
- Oxygen saturation decrease to < 88% for > 10 minutes following the SI procedure
- FEV 1 decrease to less than 80% of the patient's baseline during or after the SI procedure that does not respond to bronchodilator treatment (FEV1 > 90% after maximum of two treatments).
- Wheezing or dyspnea that is unresponsive to intervention and results in hospitalization.
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Plan for unanticipated AE reporting: All unanticipated AEs related to the study procedures that
are severe or serious will be reported by the investigator to the IRB and the SAC of the GCRC
within 7 days of notification of the investigator.
Plan for anticipated AE reporting: All serious anticipated AEs related to the study procedures
will be reported by the investigator to the IRB and the SAC of the GCRC within 7 days of
notification of the investigator.
Plan for ongoing review of results: The PI will be notified within 24 hours by the CF research
nurse of any early terminations of sputum induction due to an adverse event.
Plan for safety review: the PI will perform a cumulative review of all adverse events and
premature SI terminations review every 6 months after study initiation or after completion
of 50% of subject visits, whichever occurs first.
Plan for annual reporting: A summary of the investigation including all adverse events and how
they were handled, enrollment, drop-outs and reason for discontinuation and any protocol
modifications will be provided to the IRB and the CRC on an annual basis.
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