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GCP TRAINING QUIZ

CITI GCP Training

GCP TRAINING QUIZ Exam Questions with Verified Answers

ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must: - Answer- Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records. ICH (2016) E6 Section 4.8.10(n) states that the informed consent should indicate that "the monitor(s), the auditor(s), th...

CITI GCP Training Exam Questions With Correct Solutions.

ACRP Boot camp Exam Questions and Answers Already Passed The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers is: a. phase 1 b. phase 2 c. phase 3 d. phase 4 a Which of the following is not a type of patient-oriented research? a. IND/IDE clinical trials b. investigator initiated trial (IIT) c. Post market device registries d. outcome and health services research d Who is ultimately responsible for all aspects of the research conducted at a site? ...

CITI GCP Training Questions and Answers | Latest Version | 2024/2025 | 100% Verified The International Council for Harmonisation (ICH) guideline E6 has more extensive requirements for maintaining confidentiality of medical records and granting access to third parties compared to the FDA and HHS. According to the ICH E6 guideline, investigators must: Clearly disclose to participants in the informed consent form that the monitor, auditor, Institutional Review Board (IRB)/Independent ...

GCP TRAINING QUIZ Exam Questions with Verified Answers.

GCP TRAINING QUIZ Exam Questions with Verified Answers.

CITI GCP Training, Exam Review Questions and answers, rated A+ ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must: Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records. ICH (2016) E6 Section 4.8.10(n) states that the informed consent...