Gcp training - Study guides, Class notes & Summaries

GCP TRAINING EXAM WITH ALL QUESTIONS AND ANSWERS ...

1A protocol that has been previously reviewed by the full IRB is always eligible for expedited review. A. TRUE B. FALSE - Answer-B. FALSE 1A serious adverse event (SAE) should be reported to the local IRB within what period of time after learning of the event? A. 5 days B. 2 weeks C. 24 hours D. Follow the local IRB reporting guidelines. - Answer-D. Follow the local IRB reporting guidelines. 1Essential documents collected for research projects may be audited or inspected for GCP complia...

GCP TRAINING QUIZ Exam Questions with Verified Answers.GCP TRAINING QUIZ Exam Questions with Verified Answers.

CITI GCP Training Study Guide Test. 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 should indicate that "the...

GCP TRAINING EXAM QUESTIONS CORRECTLY ANSWERED. After the IRB reviews and approves your protocol, informed consent, and associated documents, you should receive: A. A phone call telling you the study can now proceed. B. A personal visit from the IRB chair telling you how excited he/she is about your research. C. Written notification of the IRB decision and the approved versions of the protocol and informed consent forms. D. Nothing. If you do not receive a response in 30 days, you can...

CITI GCP Training Questions and Answers Graded 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 should indicate ...

After the IRB reviews and approves your protocol, informed consent, and associated documents, you should receive: A. A phone call telling you the study can now proceed. B. A personal visit from the IRB chair telling you how excited he/she is about your research. C. Written notification of the IRB decision and the approved versions of the protocol and informed consent forms. D. Nothing. If you do not receive a response in 30 days, you can proceed with your study. correct answersC. Written n...

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 should indicate that "the monitor(s), the auditor(s), the IRB/IEC,...

GCP TRAINING QUIZ Exam Questions with Verified Answers.GCP TRAINING QUIZ Exam Questions with Verified Answers.

GCP TRAINING QUIZ