Penn CR: Onboarding Assessment Questions With Answers Well Elaborated.

Case Report Form, Investigator's Brochure, and Trial Protocol - correct answer Which of the following are Essential Documents? Institutional Review Board (IRB) - correct 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) - correct answer What makes an Adverse Event (AE) or Adverse Drug Reaction (ADR) Serious? prior to the participation in the research study - correct 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 - correct answer Who is responsible for signing the consent form? Office of Clinical Research Penn Manual - correct 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 - correct answer Why are ethics important in clinical research? IRB/IEC - correct answer What is the name of the governing body that is established to ensure clinical trials are carried out ethically? Finacne, IND/IDE, Compliance - correct answer The OCR is a central office in the Perelman School of Medicine that consists of the following units to support all clinical research efforts Respect for Persons, Justice, Beneficence - correct answer 3 Core principals are identified in the Belmont Report to provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research - correct answer The purpose of informed consent is (all of the choices) - correct answer What are the benefits to adhering to ethical practices? all of the choices - correct answer What is the process of obtaining consent if a waiver of documentation of informed consent is approved by the IRB? monitor - correct answer Who has the responsibility to verify that the requirements for the quality of the trials related activities have been fulfilled? investigator and sponsor - correct answer The two key players responsible for trial conduct are Investigator Brochure - correct answer What document provides investigators with a summary of the known pre-clinical and clinical data for a specific investigational product including a list of known adverse drug reactions? Clinical Research Staff Portal and Registry (CRSSPR) - correct answer In order to continue with your Cost Finder and Research Billing Application access you must complete a profile in which of the following systems? regulatory binder / site file - correct answer Which type of file holds all essential documents for the individual trial? all are correct - correct answer What does the informed process consent involve? Belmont Report - correct answer Which of the following describes the Ethical Principles Guidelines for the Protection of Human Subjects of Research and addresses ethical principles that form the basis for the National Commission's topic-specific reports? ethical codes - correct answer The rules that govern how ethics are to be handled are called what? all ways listed are valid - correct answer Which of the following are ways to paya patient that is participating in a clinical trial? Immediately - correct answer Adverse event have to be reported to the investigators and sponsors.... False - correct answer An illiterate person can never participate in a clinical trial bc they are not able to sign the informed consent form auditor - correct answer Who has the responsibility to evaluate trial conduct and compliance with protocol, SOPs, GCP, and the applicable regulatory requirements? iConnect - correct answer What is Penn's version of ClinicalT? Purpose, Risks, Benefits - correct answer What content is required to be on informed consents