SOCRA CCRP Practice Exam

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What is required for Phase 1 protocols according to the FDA?

Final results
General outline of planned investigation
Detailed financial disclosures
Comprehensive risk analysis

The correct answer is: General outline of planned investigation

According to the FDA, a general outline of the planned investigation is required for Phase 1 protocols. This is because Phase 1 trials are used to study the initial safety and tolerability of a new drug or treatment on a small group of healthy volunteers. Final results would not be available before starting the trial, so they are not required at this stage. Detailed financial disclosures and a comprehensive risk analysis may be necessary in later phases, but they are not directly related to the initial review and approval process for Phase 1 protocols. Therefore, they are not required at this stage.