Clinical Research Professional Certification Preparation And GCP Review Course

Flashcards covering key concepts from the Clinical Research Professional Certification Preparation And GCP Review Course.

The Society of Clinical Research Associates (SOCRA) has developed an International Certification Program to create an __________ standard of knowledge, education, and experience.

internationally-accepted

Informed consent must be obtained only under circumstances that provide the prospective subject or representative sufficient opportunity to consider and minimize the possibility of __________.

coercion or undue influence.

The Nuremberg Code emphasizes that __________ consent of the human subject is absolutely essential.

voluntary

In the Declaration of Helsinki, it is stated that the physician’s duty is to promote and safeguard the __________, well-being, and rights of patients involved in medical research.

health

The Belmont Report identifies three basic principles relevant to the ethics of research involving human subjects: Respect for persons, __________, and Justice.

Beneficence

According to the Belmont Report, individuals should be treated as autonomous agents capable of deliberating about their __________.

personal goals

FDA regulations are published as part of chapter 21 of the CFR, specifically in parts 50, 56, __________, and 812, regarding human subject protection.

312

The Common Rule provides a robust set of protections for research subjects at __________ CFR 46.

45

The IRB has the authority to approve, require modifications in, or __________ research protocols.

disapprove

According to the Nuremberg Code, the degree of risk never to exceed the __________ or humanitarian value.

benefit