Complete Package Deal For ACRP-CP Certification Exam Study Guide Questions and Answers 2024

1571 - IND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually 1572 - Investigator statement; commitment, done nationally and internationally by sponsors intending to hava marketing aproval for IP IB - Clinical and non-clinical ...

What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? -Correct Answer Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requiremen...

Treatment Emergent -Correct Answer An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state. treatment effect -Correct Answer An effect attributed to a treatment in a clinical trial. In most clinical trials the treatment effect of int...

Phase I -Correct Answer The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers Who is ultimately responsible for all aspects of the research conducted at a site? -Correct Answer Principal investigator Define GCP -Correct Answer An international quality sta...

What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? -Answer- Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for:...

What are the three fundamental ethical principles outlined in the Belmont Report (1979) for the protection of human subjects in research? Beneficence, Justice, Respect for Persons What is the purpose of the Belmont Report (1979)? To establish ethical principles and guidelines for the protection o...