Gcp training - Study guides, Class notes & Summaries

AGCP TRAINING Questions and answers, rated A+fter 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 proc...

GCP TRAINING QUIZ

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...

GCP EXAM QUESTIONS AND ANSWERS 100% CORRECT What words are missing from the following in ICH GCP: The Sponsor should update the XXXX as significant new information becomes available? investigator's brochure Who is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs: sponsor According to ICH GCP section 8, what is the purpose of IRB/IEC composition? A. To document that the IRB/IEC is constituted in agreement with GCP ...

Citi Training GCP and Refresher

SOCRA Certification questions with complete solution Investigator should (qualifications/agreements) - correct answer-Be qualified by training/education and expertise Be familiar with the product investigational Be aware and comply with GCP and regulatory requirements Permit auditing/monitoring Delegate authority and maintain a log Be responsible for the training of the staff Nuremberg Code - correct answer-(1947) Ten guidelines for the ethical treatment of human subjects in res...

Social/Behavioral Research Training (CGood Clinical Practice (GCP) - ANSWER international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects Clinical Trial (NIH Def) - ANSWER Beyond just biomedical studies, Social and Behavioral interventions are now defined as clinical trials. Why implement GCP? - ANSWER - Protect participants - Prevent non-compliance issues - Yield quality data for reproduc...

Social/Behavioral Research Training (CITI) Good Clinical Practice (GCP) - correct answer international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects Clinical Trial (NIH Def) - correct answer Beyond just biomedical studies, Social and Behavioral interventions are now defined as clinical trials. Why implement GCP? - correct answer - Protect participants - Prevent non-compliance issues - Y...

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 Which of the following is not a type of patient-oriented research? a. IND/IDE clinical trials b. investigator initiated trial (11T) c. Post market device registries d. outcome and health services research Who is ultimately responsible for all aspects of the research conducted at a site? a. IRB b. sponsor c. principal investigator d. clinic...