Create a Data and Safety Monitoring Plan
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Whatever the structure of the monitoring plan, the PI and IRB or IEC are responsible for oversight of safety monitoring along with one of the following:
- independent safety monitor
- independent monitoring committee
- DSMB.
See We'll Discuss Data and Safety Monitoring With You for additional information.
In your monitoring plans, include a description of the mechanisms you will use to report adverse events to the IRB or IEC, FDA, and NIH.
A peer review group will review your plan, and its comments or concerns will appear in your summary statement.
Each NIAID division has a system to oversee and monitor conduct of clinical trials to ensure participants' safety and the validity and integrity of data. That oversight is separate from the data and safety monitoring implemented in your study. For more information see the NIH Policy for Data and Safety Monitoring and Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials.
Phase I and II
For phase I and II clinical trials, you must include a general description of your data and safety monitoring plan in your research application.
After award but before you begin a clinical trial, you'll need to submit a detailed monitoring plan as part of your protocol, first to your IRB or IEC and then to NIAID for review
and approval.
Since the degree of monitoring should correspond with level of risk,
phase I and II clinical trials may have more leeway in the type of monitoring
used. However, if you're planning a clinical trial that
involves potentially high risks or special populations, you must
consider additional monitoring safeguards, which could include a
DSMB.
Phase III
For phase III clinical trials, you'll need to submit an even more detailed monitoring plan in your
initial application and include plans for using a data and safety
monitoring board (DSMB).
All phase III clinical trials must use a DSMB. All multisite clinical trials
involving interventions that entail potential risk to participants
must also use a DSMB.
Multisite
If you're planning multisite phase I or II clinical trials, you'll need to organize one of the above monitoring options to prepare timely summary reports of adverse
events and distribute them to all sites and IRBs or IECs. The frequency of the summary reports will depend on the nature of the clinical trials. For additional guidance on reporting adverse events for multisite clinical trials with a DSMB,
see the June 11,
1999, Guide notice.
Additional Resources
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