Ich efficacy guidelines - Study guides, Class notes & Summaries

ICH stands for - Answer- International Council for Harmonisation Regulatory Reviewers focus on - Answer- Focus on study validity and results- want to see GCP used to produce high quality data based on the protocol Inspectors focus on - Answer- Focus on study conduct and oversight True or False. ICH brings regulatory authorities and the pharmaceutical industry together to discuss scientific and technical aspects of drug registration - Answer- True What is the mission of ICH? - Answer-...

CITI Good Clinical Practice Course (US FDA focus)Which of the following are the three principles included in the Belmont Report? - correct answer Respect for Persons, Beneficence, Justice. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? - correct answer Determining that the study has maximized benefits and minimized risks. Which of the following best describes the principle of Respect for Persons as described in t...

Good Clinical Practice (GCP)Which of the following are the three principles included in the Belmont Report? - correct answer Respect for Persons, Beneficence, Justice. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? - correct answer Determining that the study has maximized benefits and minimized risks. Which of the following best describes the principle of Respect for Persons ad described in the Belmont Report - c...

CITI Good Clinical Practice (US only Drug or Device Research)Which of the following are the three principles included in the Belmont Report? - correct answer Respect for Persons, Beneficence, Justice. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? - correct answer Determining that the study has maximized benefits and minimized risks. Which of the following best describes the principle of informed consent as descr...

5 - ANSWERThe minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained - ANSWERIn a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor - ANSWERThe responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study ...

CCRC Exam Prep Questions With 100% Correct Answers. What is an Adverse Event (AE) ? Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. (ICH GCP E6 1.2) What is an Adverse Drug Reaction (ADR)? All noxious and unintended responses to a medicinal product related to any dose. (ICH GCP E6 1.1) What is the definition of Severity? intensity What are t...

Nuremberg Code (1947) A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. right to end trial if needed ...

Citi Training GCP and Refresher Exam Questions and answers, Rated A+ Which of the following defines phase I research as it relates to non-clinical and other phases of research: - -Phase I research is the first phase of research after animal testing and helps define future phase II and III studies. Approximately how many subjects generally participate in phase I studies? - -20-80 As the amount of adaptive study designs and multiple-arm protocols increases, researchers are now adding sm...

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...

What is an Adverse Event (AE) ? - Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. (ICH GCP E6 1.2) What is an Adverse Drug Reaction (ADR)? - All noxious and unintended responses to a medicinal product related to any dose. (ICH GCP E6 1.1) What is the definition of Severity? - intensity What are the criteria for a Serious Adverse Event? - Any...