EDF 6226 final Exam Questions with correct Answers ANSWERS|AGRADE.

A blood sample collection is required to screen for bloodborne pathogens before subject could be enrolled in a study. Where will subjects find information of the procedures and any foreseeable risks or inconveniences? - ansICF A Clinical Research Coordinator (CRC) adjusted the dose of the Investigation Product (IP) for a subject as the subject was suffering from Adverse Events (AEs) like headaches and vomiting. When is a CRC allowed to do this task? - ansOnly when the CRC is a qualified physician and has been delegated this responsibility by the PI A CRA notices during an onsite visit that the date on IRB/IEC approval letter for a protocol is prior to the effective date indicated on the cover page of the protocol and the signatures of the investigator and sponsor. What should the CRA do FIRST? - ansConfirm dates of initial receipt of the sponsor protocol and the IRB/IEC submission dates. A CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: - ansvalidation, accuracy, reliability, and completeness. A medical student is approached by a faculty member for possible participation in a cricothyroidotomy simulation research study. Which of the following increases risk to the subject? - ansConsenting in the presence of figure of authority A new study is investigating a new IND "glue" that can be used to hold skin cuts together and decrease the chance of scaring. You know children should be included because ICH E8 considers them a special population. In designing the protocol you should expect to: - ansInclude children in the general plan from the beginning A non-English speaking subject has responded to a recruitment ad to participate in a trial for treatment of her diabetes. She arrives at the site with her daughter who is fluent in English. The informed consent forms are only available in English. What actions are compliant with GCP? - ansCall the sponsor to request a translation of the informed consent A research study, in which there is no intended clinical benefit to the subject, is being submitted to the IRB/IEC. What benefit information should be included in the ICF? - ansWording indicating that there is no expected benefit should be included. A research subject's responsibilities for study participation should be described in the: - ansICF A site is in the start-up phase of an industry-sponsored phase 3 trial, and has received IRB/IEC approval. The site can begin enrolling subjects after: - ansa signed clinical trial agreement between the