Reference no: EM133439305
1. The Trial Master File refers to a repository of documents that collectively can be used by monitors, auditors, and Sponsors to demonstrate that a clinical trial has been conducted in compliance with Good Clinical Practice (GCP) and the approved protocol.
TRUE OR FALSE
2. Children who are old enough to understand medical discussions are sometimes asked to give assent for care. Assent means that the child is agreeing to the treatment or procedure. Children can also dissent, which means they do not agree to participate. The age at which assent is requested varies by institution and can be as young as 7 years old. Assent is not required by law, but many institutions require children who are developmentally and cognitively able, to participate in decision making.
TRUE OR FALSE
3. Securing compliance in a clinical trial is important for the documentation process - it has nothing to do with safety. TRUE OR FALSE
4. The Sponsor may delegate activities to a CRO and notice to the FDA under an IND is not required.
TRUE OR FALSE
5. In a Quality Management System, risk identification is limited to pivotal Phase 3 studies only.
TRUE OR FALSE
6. FDA's Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections and data audits designed to monitor the conduct and reporting of FDA regulated research. The BIMO program is intended for new medicines only.
TRUE OR FALSE
7. Electronic Informed Consent should be interactive electronic-based technology and include diagrams, images, graphics, videos, and narration to support understanding but based on reading level, age, and language.
TRUE OR FALSE
8. Risk-based" and "remote" are monitoring terms that can be used interchangeably.
TRUE OR FALSE
9. The regulators do not care about how monitoring is performed - just that it is done.
TRUE OR FALSE
10. BIMO Inspections are only performed at the Sponsor site.
TRUE OR FALSE