Clinical Research Coordinator Certification Quiz

Regulatory guidelines require an IRB to have at least five members. This ensures diversity in expertise, background, and perspective, allowing ethical, scientific, and community viewpoints to be represented. Fewer members would limit comprehensive ethical review and compromise subject protection.

A 30% dose reduction means the patient receives 70% of the original dose. Multiplying 110 mg/m² by 0.7 results in 77 mg/m². This calculation ensures toxicity is reduced while maintaining therapeutic exposure. Accurate dose adjustment is critical in clinical trials to protect participant safety.

The sponsor is responsible for ensuring investigators are adequately informed and trained on the protocol. This includes providing study documents, protocol explanations, and ongoing support. While IRBs review protocols and the FDA regulates trials, the sponsor ensures investigator comprehension and compliance.

A significant risk device is one intended as an implant or that presents serious potential risk to health or safety. Regulatory definitions exclude cosmetic or entertainment devices. Classification determines whether FDA approval and extensive oversight are required before clinical use.

The IRB is tasked with protecting human subjects by reviewing protocols, monitoring safety, and ensuring ethical standards. While sponsors and investigators manage trial execution, the IRB independently evaluates risk, consent processes, and participant welfare throughout the study.

Informed consent must be obtained before any study-related procedure occurs. This ensures participants understand risks, benefits, and rights before participation. Consent obtained later would violate ethical standards and regulatory requirements.

The ICH includes regulatory authorities from the European Union, United States, and Japan, along with other regions as observers. South America is not an official ICH member. The organization focuses on harmonizing pharmaceutical regulations among major drug-developing regions, ensuring global standards for safety, quality, and efficacy.

Phase I trials focus on safety, tolerability, and dosage in a small group of participants. These studies identify adverse effects and determine safe dosage ranges before proceeding to larger efficacy-focused phases.

The Declaration of Helsinki establishes ethical principles for medical research involving human subjects. It emphasizes informed consent, risk minimization, and participant welfare. It serves as a foundational document guiding global research ethics alongside regulatory frameworks.

The FDA conducts inspections to ensure compliance with Good Clinical Practice. These inspections verify data integrity, subject protection, and regulatory adherence. While sponsors and IRBs monitor internally, FDA oversight provides independent regulatory enforcement.