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Protocol Consultation

Regulatory Knowledge and Support provides protocol consultation

A Principal Investigator may be the primary expert in knowing the scientific background and procedures of a protocol; however, there are also regulatory and ethical issues to be aware.

These domains are the expertise and the primary perspective provided by Regulatory Knowledge and Support, and may have operational implications that pertain to inclusion/exclusion criteria, identification and recruitment of human subjects, the consent process and document, and study monitoring.

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Regulatory Knowledge & Support

Regulatory and Ethics
Regulatory Documents
Acknowledging CTSA grant support in publications

Consent Document Preparation
Data and Safety Monitoring
IRB/Grant Submission
Research Subject Advocate
MultiCenter IRB Review

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