SOCRA CCRP EXAM 2024 QUESTIONS WITH COMPLETE SOLUTIONS

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. The responsibility for ensuring that the investigator 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 person with respect to an investigation, shall permit authorized FDA em