Table
Name | Definition |
|---|---|
| AAHRPP | Association for the Accreditation of Human Research Protection Programs, Inc. |
| Adverse Event | An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy). |
| Assent | Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research. |
| CCC | Comprehensive Cancer Center |
| Common Rule | Another term for 45 CFR 46 Federal Policy for the Protection of Human Subjects (DHHS Policy for the Protection of Human Research Subjects). |
| Data and Safety Monitor | An individual assigned to conduct interim monitoring of accumulating data from research activities to assure the continuing safety of research participants, relevance of the study question, appropriateness of the study, and integrity of the accumulating data. The individual should have expertise in the relevant medical, ethical, safety and scientific issues. |
| Data and Safety Monitoring Board (DSMB) | A formally appointed independent group consisting of at least three (3) members assigned to conduct interim monitoring of accumulating data from research activities to assure the continuing safety of research participants, relevance of the study question, appropriateness of the study, and integrity of the accumulating data. Membership should include expertise in the relevant field of study, statistics, and research study design. |
| Data and Safety Monitoring Committee (DSMC) | Another name for a DSMB, or a less formal Board. |
| Data and Safety Monitoring Plan (DSMP) | A DSMP describes how the Investigator plans to oversee the research participant’s safety and welfare and how adverse events will be characterized and reported. The intensity and frequency of monitoring should be tailored to fit the expected risk level, complexity, and size of the particular study. |
| FDA | The Food and Drug Administration |
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