Gradespins

Scientific Method 4 Steps correct answers1. observe phenomenon (identify variables important in explaining behaviors) 2. formulate explanations (initial observations allow you to develop a hypothesis about the variables identified) 3. further observing and experimenting (detailed observations of behavior of interest, directly testing hypothesis) 4. Refining and Retesting explanations (supported hypotheses are refined and subject to further exploration) disconfirmed hypothesis may be reworked ...

Operational Definition correct answersDefining a concept by the operations used to represent or measure it Operationalization correct answersCampbell's term for operation definition Constant correct answersSomething that does not vary Categorical Variable correct answersVaries by type or kind Confounding Variable correct answersAn extraneous variable that if not controlled for will eliminate the researchers ability to claim that the IV causes changes in the DV Correlational Study...

Nuremberg Code (1947) correct answersA 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 correct answers1. 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...

What does CRA stand for? correct answersClinical research associate What's 2 other names for a CRA? correct answersTrial monitor, clinical monitor What is another name for a study? correct answersProtocol and clinical trial The main ingredient in a drug is called? correct answersA compound Pre-clinical trials are done on?? correct answersAnimals, microorganisms, and tissue Before any drug can make it to market how many phases must they go thru? correct answers4 phases Which ph...

declaration of helsinki (1964) correct answers-ethical principles (31) for research with human subjects -international standard -subjects take precedence -combing research and clinical care -adapted from Nuremberg Code by the World Medical Association ICH - international conference on harmonisation correct answersinternational authority on clinical research theory and principles ICH guidelines correct answers4 major categories QUALITY - chemical/pharm. Assurance (stability testin...

Who was tried in the Nuremburg Military Tribunals and why? correct answersDoctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent What was the outcome of the Nuremburg Military Tribunals? correct answersAfter 140 days of proceedings with testimony of 85 witnesses and submission of 1,500 documents, American judges convicted 16 doctors on 8/20/1947. Seven were sentenced to death and executed 6/2/1948....

What are the two overarching goals of ICH GCP? correct answersstandard that protects the rights, safety and welfare of human subjects, minimizes human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public What are the 13 principles of ICH/GCP? correct answers1. ethical conduct of clinical trials 2. benefits justify risks 3. rights, safety & well being of subjects prevail 4. non clinical & clinic...

FDA correct answersFood and Drug Administration ICH correct answersInternational Conference of Harmonization - homogenized regulations in many drug markets including the US, EU, and Japan. GCP correct answersGood Clinical Practice Bioavailability correct answersThe degree to which a drug is absorbed or becomes available to a specified location within the body Clinical Trial correct answersAny study, utilizing human subjects, which studies the pharmacological and/or pharmacodynamic ef...

what are the three causes that led to the formation of ICH? a. lack of eligible patient to recruit, location of sites, access to treatment b. incomplete medical records, inadequate supplies, equipment not in good working order c. Insufficient laboratory data, sites not conducive to clinical trials, research being conducted is not applicable to the area in which the patient population resides. d. Delays in the introduction of new medicines, differing regulatory requirements from one country t...

International Conference on Harmonization correct answersIn 1990, a conference called the International Conference on Harmonization took place and GCP guidelines were created. According to this document, GCP is: What is GCP correct answersA standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentia...