bundle for ACRP CCRC Exam

A subject in an arthritis clinical trial develops a severe cold and flu like symptoms. This event is most likely classified as a) An adverse event b) An adverse drug reaction c) An unexpected adverse drug reaction d) A serious adverse event b) A causal relationship between drug and advers...

The _________ has developed the Declaration of Helsinki (DoH): - ANSWER World Medical Association; as a statement of ethical principles to provide guidance to physicians and other participats in medical research involving human subjects. (DoH) It is the duty of ________________ in medica...

What are expected or possible consequences of over-estimation of recruitment potential? - ANSWER - The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will...

What statements are true concerning an adverse drug reaction? - ANSWERS - All noxious and unintended responses to a medicinal product related to any dose should be considered as an ADR - An ADR suggests a relationship to trail medication - All ADRs must be documented What Adverse Events (AE...

Approval (in relation to Institutional Review Boards) - ANSWER The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable re...

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

Belmont Report (1979) - ANSWER ethical principles and guidelines for the protection of human subjects of research. respect for persons - ANSWER individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person - ...