CITI CRC Course Training

In a drug study, what is the most important FDA document that is signed by the PI? A) Informed Consent Form B) Subject Diary C) IRB/IEC Submission Form D) 1572 Statement of Investigator Form

1572 Statement of Investigator Form

What is the main objective of a phase 2 clinical trial? A) To test a new molecule in subjects with the disease of interest to obtain safety information and preliminary evidence of efficacy B) To obtain additional safety information on a marketed drug C) To test a new molecule on thousands of human subjects in order to confirm the safety and efficacy profile of a new drug on a large sample size. D) To test a new molecule for the first time in human subjects

A. To test a new molecule in subjects with the disease of interest to obtain safety information and preliminary evidence of efficacy

The Principal Investigator (PI) can delegate clinical trial site responsibilities to the following individuals on the study team as long as they are qualified by education, training, experience, and are properly documented and listed on the site delegation log. A) The pharmaceutical company sponsoring the study B) Clinical research coordinator (CRC) and clinical research associate (CRA). C) IRB/IEC D) CRC, sub-I, and site support team (phlebotomist, medical assistant, subject recruiter

CRC, sub-investigator (SI), and site support team (phlebotomist, medical assistant, subject recruiter)

Chart review can be used to screen subjects as long as: A) The protocol is for a Phase III placebo controlled clinical trial B) The information is de-identified when used for a prospective study C) It is limited to designing or preparing a research protocol or assessing the feasibility of conducting a study. D) Informed consent is obtained from the subject

It is limited to designing or preparing a research protocol or assessing the feasibility of conducting a study *NOTE: The use of chart review is limited to designing a research study, preparing a research protocol or assessing the feasibility of conducting a study (NIH 2012; HHS 2013).

What is the most important factor to consider in a site's decision to participate in competing clinical trials? A) Clinical trial business is competitive so it is acceptable to participate in as many trials as possible. B) There is an imminent risk for struggle in prioritizing study-related activities when a site is involved in similar clinical trials for different sponsors. C) The sponsor will be disappointed with a site's level of engagement if it turns down an opportunity to participate. D) Competing studies are more financially rewarding to the site.

There is an imminent risk for struggle in prioritizing study-related activities when a site is involved in similar clinical trials for different sponsors.