Ich Gap|Graded A|

What is the purpose of ICH-GCP? To standardize the design, conduct, recording, and reporting of the clinical trials What is the purpose of the IRB/IEC? To protect subject's safety LAR stands for: Legally authorized representative What is the minimum number of members on the IRB/IEC? - 5 Who is responsible for providing the protocol? -Sponsor What does DSMB stands for? Data and Safety Monitoring Board What should be the Main concern of the Physician in any trial? The welfare of the subjects World Medical Association (WMA) is called? The Declaration of Helsinki Process in which the subject voluntarily confirms their willingness to participate in the trial? Informed Consent One of the primary purposes of Phase I study is to: Determine the metabolic and pharmacologic action of the dug in humans What is the purpose of the DSMB? -To assess the progress of the clinical trial - Assess safety Data - Assess clinical data endpoints Who is ultimately responsible for the Source Data Verification? SDV -The Monitor Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subjects? True The Declaration of Helsinki was developed by: The World Medical Association Phase III trials -Determines therapeutic benefit -usually done in larger specific population Phase IV trial Therapeutic use begins after drug approval