Citi gcp training - Study guides, Class notes & Summaries

Citi Training GCP and Refresher

CITI training Questions with complete solutions 2023 What must you file before conducting human clinical trials with an experimental drug? IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this document notifies FDA of relevant changes in investiga...

Good 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 reproducible findings Sponsor - ANSWER - Re...

Good 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 reproducible findings Sponsor - Answer- ...

CH 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, ...