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SOCRA CCRP ACTUAL EXAM 300 QUESTIONS AND CORRECT DETAILED ANSWERS TOP RATED VERSION FOR ALREADY A GRADED WITH EXPERT FEEDBACK|BRAND NEW|REVISEDR381,38
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SOCRA CCRP ACTUAL EXAM 300 QUESTIONS AND CORRECT DETAILED ANSWERS TOP RATED VERSION FOR 2024 -2025 ALREADY A GRADED WITH EXPERT FEEDBACK|BRAND NEW|REVISED The responsibility for ensuring that the invest igator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator - answer - C) Sponsor Records inspection - answer - A sponsor, IRB, or investigator, or any other person acting on behalf of such a perso n with respect to an investigation, shall permit authorized FDA employees, at reasonable times and in a reasonable manner, to inspect and copy all records relating to an investigation. Entry and Inspection - answer - A sponsor or an investigator who has authority to grant access shall permit authorized FDA employees, at reasonable times and in a reasonable manner, to enter and inspect any establishment where devices are held (including any establishment where devices are manufactured, processed, packed, ins talled, used, or implanted or where records of results from use of devices are kept). Who is responsible for maintaining the close out report? - answer - Sponsor Records identifying subjects. - answer - An investigator shall permit authorized FDA employees to inspect and copy records that identify subjects, upon notice that FDA has reason to suspect that adequate informed consent was not obtained, or that reports required to be submitted by the investigator to the sponsor or IRB have not been submitted or a re incomplete, inaccurate, false, or misleading. A patient received an initial dose and had no initial reaction. The protocol says the patient needs to increase it by 20%. The initial dose was 370mg^3/m; what is the next treatment? - answer - 444mg^3/m Which countries are included in the ICH GCP? - answer - European Union, Japan, United States, Canada and Switzerland What is the monitor not responsible for? A) Patient information B) Sponsor SOP C) Protocol/ICF D) Reporting to IRB - answer - According to ICH E6, an inspection is defined as: - answer - An official review of documents, facilities, records, and any other resources related to a clinical trial. An investigator shall submit a final report to the sponsor and the reviewing IRB within. - answer - 3 months after termination or completion of the investigation or the investigator's part of the investigation. If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within - answer - 5 working days. What FDA document must all investigators signed prior to participating in a drug clinical trial? - answer - 1572 The contents of a protocol should generally contain: (A) Trial objectives and purpose (B) Assessment of efficacy (C) Data handling and recordke eping (D) All of the above - answer - (D) ALl of the above An investigator shall notify the sponsor and the reviewing IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency no later than - answer - 5 working days. Sponsor must report to FDA and all investigators in an IND safety report of potential serious risks no later than - answer - As soon as possible but no later than 15 calendar days Device: Withdrawal of IRB approval - answer - 5 wor king days The FDA form 483 is used for - answer - Inspectional Observations What is the federal department responsible for helping people of Canada maintain and improve their health? - answer - Health Canada . Who monitors the progress of all clinical tri al investigations being conducted under its IND? - answer - The Sponsor . A(n) _______________ is a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. - answer - Case Report Form - CRF ________________ is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. - answer - Direct Access
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