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Biometrics - correct answer 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 - correct answer 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 - correct answe...

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 nee...

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Nuremburg Code -ANSWER The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements -ANSWER 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 withdra...

The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? A. European Union, US and Canada B. Mexico, European Union and US C. US, Russia and European Union D. European Union, Japan and US - ANSWER-D. European Union, Japan and US What other organizations are represented in the ICH Steering Committee? A. Australia, Canada, the Nordic Countries and the World Health Organization B. Canadian Health Branch, Africa A...

Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - ANSWER-False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. If the electronic records meet the criteria specified in 21 CFR 11, thr agency will consi...

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