Penn CR: Onboarding Assessment Exam
Questions and Answers 100% Pass
Case Report Form, Investigator's Brochure, and Trial Protocol - ANSWER ✔✔-Which of the following are
Essential Documents?
Institutional Review Board (IRB) - ANSWER ✔✔-Who is ultimately responsible for approving all
recruitment materials that a study team intends to use to recruit potential subjects?
(all of the choices) - ANSWER ✔✔-What makes an Adverse Event (AE) or Adverse Drug Reaction (ADR)
Serious?
prior to the participation in the research study - ANSWER ✔✔-If consent is obtained the same day that
the subject's involvement in the study begins, the consent progress note should state that "The consent
was obtained..."
The subject and the person obtaining consent - ANSWER ✔✔-Who is responsible for signing the consent
form?
Office of Clinical Research Penn Manual - ANSWER ✔✔-Where can you find at Penn, a comprehensive
help guide to help you through the course of any research project - from study inception to study close-
out:
ensures respectful treatment of all subjects - ANSWER ✔✔-Why are ethics important in clinical research?
IRB/IEC - ANSWER ✔✔-What is the name of the governing body that is established to ensure clinical
trials are carried out ethically?
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