SOCRA CCRP Practice Exam

What items should be present in an Investigator's Brochure?

1. Only drug description and formulation

2. Pharmacological effects only

3. Drug description, Pharmacological effects, PK and biological disposition, Safety and effectiveness, Possible risks and side effects

4. Only the PK and biological disposition of drug

The correct answer is: Drug description, Pharmacological effects, PK and biological disposition, Safety and effectiveness, Possible risks and side effects

An Investigator's Brochure is an essential document for clinical trials as it provides detailed information about the drug being studied to investigators, sponsors, and regulatory authorities. Option A is incorrect because it only covers basic information about the drug and does not provide a comprehensive overview. Option B is incorrect because it only covers the pharmacological effects and does not provide other necessary information. Option D is incorrect because it only covers the drug's pharmacokinetics and biological disposition, leaving out other important information. Therefore, option C is the correct choice as it includes all the necessary components such as drug description, pharmacological effects, PK and biological disposition, safety and effectiveness, and possible risks and side effects. These components are crucial for researchers and regulators to have a complete understanding of the drug and its potential risks and benefits.