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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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Related Services Related Pages Related Programs

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

IND/IDE Support
Good Clinical Practice Training
Acknowledging CTSA grant support in publications

Regulatory Knowledge & Support

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