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Average Rating: 0/5
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User Rating: 0/5
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1
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3
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4
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5
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0/5
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0
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Ratings
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110
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Views
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0
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Related
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1
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Revisions
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Status:
Ready
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-
Average Rating: 0/5
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User Rating: 0/5
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1
-
2
-
3
-
4
-
5
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Score
0/5
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0
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Ratings
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68
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Views
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0
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Related
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0
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Revisions
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Status:
Ready
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All clinical trials require monitoring at multiple levels. The Data Safety Monitoring Board (DSMB) is required for certain types of federally funded clinical trials and strongly recommended for others. The DSMBs operate similarly to the Institutional Review Board (IRB), but is not a substitute for the IRB. DSMBs periodically review unblinded data (interventions given to study subjects are known) including adverse events and other safety concerns once a study has been initiated, whereas IRBs review studies prior to and throughout the course of the study. IRBs do not typically unblinded data.
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5
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0
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Ratings
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55
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Views
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1
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Related
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0
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Revisions
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Status:
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"A classification system that groups patients according to diagnosis, type of treatment, age, and other relevant criteria. Under the prospective payment system, hospitals are paid a set fee for treating patients in a single DRG category, regardless of the actual cost of care for the individual."
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5
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0.4/5
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0
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Ratings
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18
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Views
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2
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Related
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4
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Revisions
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Status:
Ready
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The current body of laws and regulations, clinical standards, policies and procedures, and ethical principles governing the conduct of research involving human subjects. All levels of oversight (international, federal, state, and local agencies; institutional policies; etc) should be considered when defining the GCP for a specific study. The term is commonly associated with clinical trials.
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0
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51
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Views
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0
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Related
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1
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Implant means a device that is placed into a surgically or naturally formed cavity of the human body. A device
is considered to be an implant for the purpose of 21 CFR 860 only if it is intended
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0.3/5
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0
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Ratings
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55
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Views
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0
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Related
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0
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Status:
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The Food and Drug Administration is authorized to limit competition for certain manufacturers of pharmaceuticals and biological agents (there is no authorization for market exclusivity for devices). During the period of 'market exclusivity', FDA will not approve competing products (e.g., generic drugs) for marketing. Market exclusivity is independent of any patent rights and can extend beyond the expiration of patent protections. Possible reasons for granting market exclusivity include:
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0
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63
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Views
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0
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Related
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0
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Revisions
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Status:
Ready
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Average Rating: 0/5
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User Rating: 0/5
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1
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5
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0/5
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0
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36
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Views
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0
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Related
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1
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Revisions
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Status:
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Investigators are required to maintain a detailed case history of clinical trial activities for compliance, monitoring and audit purposes. The Note to File (NTF)Â is a method of documenting events in a
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0
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54
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0
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0
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Also called '510(k) approval'. Manufacturers are required to notify the Food and Drug Administration (FDA) at least 90 days prior to marketing a new medical device. This provides FDA with time to properly classify the risk class. Manufacturers that can demonstrate that thier device is 'substantially equivalent' to a device that was legally marketed prior to May 28, 1976 (date of enactment of the Medical Device Amendments) or is not subject to 'Premarket Approval' standards. Premarket Approval is the most stringent standards to establish safety and effectiveness. FDA maintains a database of devices approved under the Premarket Norification/510(k) method (
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51
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0
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Related
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1
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Revisions
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Status:
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Any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a
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0
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29
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Views
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0
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Related
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0
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Revisions
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Status:
Ready
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An investigational device that:
(1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
(2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
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34
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0
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Related
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0
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Revisions
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Status:
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Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature,
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0
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36
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0
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0
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Revisions
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Status:
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Any adverse drug experience (see glossary entry), the specificity or severity of which is not consistent with the current investigator brochure; or, if an investigator brochure is not required or available, the specificity or severity of which is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended. [21 CFR 312.32(a)]
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33
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Views
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0
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Related
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0
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Status:
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