Term
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Definition
| Deals with electronic MRs, and electronic signatures |
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Term
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Definition
| Deals with financial disclosures of the investigators on a trial. Mandates disclosure for during the study, and for 1 year following the closure of the study. |
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Term
| How long are investigators mandated to disclose their financial interests after a study is completed? |
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Definition
| 1 year after study closure |
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Term
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Definition
| Investigational Device Exemptions. |
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Term
| According to 21CFR812, How long should records be maintained after study closure by the study site? |
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Definition
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Term
| Significant payments of other sorts in 21CFR54 means more than |
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Definition
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Term
| According to 21CFR812, if an investigator uses a device without obtaining consent, he/she must report such use to the IRB |
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Definition
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Term
| According to 21CFR812, regular reports should be made no less frequently to the IRB than |
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Definition
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Term
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Definition
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Term
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Definition
| safety profile of a compound is expanded upon. efficacy is further explored. |
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Term
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Definition
| Establish some efficacy and safety |
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Term
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Definition
| Dose escalation and optimization, first in human. |
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Term
| Health and Human services regulations apply under trials conducted under FDA regulations |
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Definition
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Term
| Serious Adverse Events should be reported to the sponsor |
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Definition
| Within 24 Hours of the site's knowledge of the event. |
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Term
| FDA requires that all study records be retained for how long after a marketing application is approved? |
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Definition
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Term
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Definition
| Deals with IRBs and their standards that they must adhere to |
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Term
| Minimum number of IRB members |
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Definition
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Term
| Who must ensure that an investigator understands the aspects of a clinical trial? |
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Definition
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Term
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Definition
| Protection of human subjects. Informed consent process, general safeguards for children in clinical trials |
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Term
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Definition
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Term
| Determinations for INDs should be made by the FDA within _____ days of application |
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Definition
| 30 days or sooner. (21CFR312) |
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Term
| Annual Reports of the study should be submitted to the FDA within ____ days of the anniversary date of the trial |
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Definition
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Term
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Definition
| disposition of unused study drug |
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Term
| According to 21CFR812, a sponsor may select an monitor that is qualified by both |
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Definition
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Term
| According to 21CFR812, who monitors the progress of the clinical trial investigations conducted under its IND? |
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Definition
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Term
| Which FDA form is used for Investigational New Drugs (INDs)? |
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Definition
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Term
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Definition
| An investigational or marketed product or placebo that is used as a reference in a clinical trial. |
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Term
| In addition to the FDA, who recommends the use of SOPs |
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Definition
| The International Conference on Harmonization. |
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Term
| Why do the FDA and ICH recommend SOPs? |
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Definition
| They ensure consistency, promote accountability and compliance with regulations and policies, and enhance efficacy. |
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Term
| Does the IB need IRB approval |
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Definition
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Term
| My one member of an IRB satisfy more than one category? |
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Definition
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Term
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Definition
| protect the rights and welfare of human subjects participating in clinical trials. |
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Term
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Definition
| One who submits the marketing application to the FDA for approval of a device, drug or biologic product. |
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Term
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Definition
| 1978, outlined ethical principles of research, including: respect for persons, beneficence, and justice. |
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Term
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Definition
| 1947.Resulted from Nuremburg Trials. Had 10 points. |
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Term
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Definition
| Introduced in 1964, cornerstone of human research ethics. |
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