SOCRA Certified Clinical Research Professional (CCRP) CCRP Question # 6 Topic 1 Discussion
CCRP Exam Topic 1 Question 6 Discussion:
Question #: 6
Topic #: 1
A pharmaceutical company is developing a biologic study. In accordance with ICH, which of the following items should be included in an investigator's brochure (IB)?
TheInvestigator’s Brochure (IB)compilesclinical and nonclinical dataon an investigational product relevant to human study.
ICH E6(R2) 7.2.3:The IB should summarizenonclinical pharmacology, toxicology, pharmacokinetics, and efficacy data, including results of animal studies.
ICH E6(R2) 7.2.4:It should also includeavailable clinical trial dataand safety experience.
The “results of recent nude mouse study” (B) are nonclinical data, which appropriately belong in the IB. Lab draw requirements (A), dispensing instructions (C), and schedules of events (D) are operational/procedural and are found in theprotocol, not the IB.
Thus, the correct answer isB (Results of recent nude mouse study).
[References:, ICH E6(R2), §7.2.3–7.2.4 (Contents of Investigator’s Brochure)., ]
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