Study guides, Class notes & Summaries

Biometrics A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digital Signature An electronic signature based upon cryptographic ...

April 30 1996 ICH GCP Development Date Quality ICH Q Efficacy ICH E Safety ICH S Multidisciplinary ICH M guidance for industry, consolidated guideance ICH E 6 Clinical Safety Data Management Definitions and Standards ICH E2A Safety pharmacology studies for human pharmaceuticals ICH S7A Electronic records, electronic signatures 21 CFR Part 11 Informed Consent 21 CFR Part 50 Financial Disclosures 21 CFR Part 54 Institutional Review Board 21 CFR Part 56 IND Appli...

How many days does a sponsor have to report an emergency use of an IP to the FDA?5 working days How many members must sit on an IRB?5 How long must an IRB retain records per 21 CFR 56?3 years after completion of research What are the criteria for IRB approval of research? (7)1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed consent will be sought from subjects or LARs 5. Informed consent ...

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 Bel...

Nuremburg Code The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements 1. Voluntary informed consent 2. research benefits society 3. should be based on prior animal work 4. avoid suffering and injury 5. research where death and disabling injury is expected shouldn't be conducted 6. risks should be justified 7. proper preparations and adequate facilities 8. conducted by scientifically qualified 9. subjects can withdraw 10. research mu...

CCRP SOCRA EXAM 2023 QUESTIONS AND ANSWERS

CCRP EXAM WITH 185 QUESTIONS AND ANSWERS 2023

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