SOCRA CCRP Exam Questions and
Answers 100% Solved | Latest Update
April 30 1996 - ICH GCP Development Date
Quality - ICH Q
Efficacy - ICH E
Safety - ICH S
Multidisciplinary - ICH M
guidance for industry, consolidated guideance - ICH E 6
Clinical Safety Data Management Definitions and Standa...
temperature - ✔✔Core Battery for Central Nervous System
Investigational New Drug Application
FDA - ✔✔Before clinical trials can be initiated, an application containing the
appropriate information must be submitted to regulatory authorities, in the
USA this is called XXXX and submitted to the XXX (21 CFR Part 312)
Unapproved drug to be shipped lawfully for the purpose of conducting
investigations of the drug - ✔✔An IND permits what? (21 CFR Part 312)
Assuring the safety and rights of subjects - ✔✔FDA's primary objective in
all phases of development is...
Phase II and III - ✔✔These phase of trials, the FDA helps assure the
quality of the scientific evaluation is adequate to permit evaluation of the
drugs safety and efficacy (21 CFR Part 312)
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