CRC Introduction questions with actual
answers
What is Good Clinical Practice (GCP)? ANS -An international ethical and scientific quality standard for
designing, conducting, recording, and reporting trials that involve the participation of human
subjects; specific PI expectations, CRCs support; design, conduct, performance, monitoring, auditing,
recording, analysis, and reporting standard provides assurance data and reported results credible and
accurate, and rights, integrity, and confidentiality of trial subjects protected; universal - sponsored
study, grant, device, investigator initiated
What is Florence? ANS -Regulatory System used in the hospital research
What are the 8 standard for clinical research professionals? ANS -1) Scientific Concepts and Research
Design
2) Ethical and Participant Safety Considerations
3) Investigational Product Development and Regulation
4) Clinical Study Operations (Good Clinical Practice)
5) Study and Site Management
6) Data Management and Informatics
7) Leadership and Professionalism
8) Communications and Teamwork
How is competency determined? ANS -Self Assessment
Observation/Manager Assessment
Client/Peer Feedback
QA Reports / Findings
Written Tests / Exams ( Entry Level Knowledge Assessment (ELKA) and Certification Exams)
Simulation Testing
answers
What is Good Clinical Practice (GCP)? ANS -An international ethical and scientific quality standard for
designing, conducting, recording, and reporting trials that involve the participation of human
subjects; specific PI expectations, CRCs support; design, conduct, performance, monitoring, auditing,
recording, analysis, and reporting standard provides assurance data and reported results credible and
accurate, and rights, integrity, and confidentiality of trial subjects protected; universal - sponsored
study, grant, device, investigator initiated
What is Florence? ANS -Regulatory System used in the hospital research
What are the 8 standard for clinical research professionals? ANS -1) Scientific Concepts and Research
Design
2) Ethical and Participant Safety Considerations
3) Investigational Product Development and Regulation
4) Clinical Study Operations (Good Clinical Practice)
5) Study and Site Management
6) Data Management and Informatics
7) Leadership and Professionalism
8) Communications and Teamwork
How is competency determined? ANS -Self Assessment
Observation/Manager Assessment
Client/Peer Feedback
QA Reports / Findings
Written Tests / Exams ( Entry Level Knowledge Assessment (ELKA) and Certification Exams)
Simulation Testing
