. In a clinical trial, part of the end requires submitting patient data to determine the effectiveness of the trial at a certain time and date. At a certain point the sponsor no longer submits patient data regarding their research; this is called a data lock. ("Bio-definitions," 2012)
2. true
3. Three reasons that adverse events are collected in clinical trials are: 1. Adverse events could result in termination or a drug or a change in dosage. A change in protocol may be needed. 2. Adverse events could affect the ethical soundness of a study. 3. To inform investigators and sponsors of these risks so they may make informed decisions about the trial. (Davis & Liu)
4. Internal adverse events are events that occur to subjects at that institution while external adverse events are experienced by subjects in other institutions apart from where they were enrolled. (Davis et al.)
5. True
6. True
7. False
9. According to 21 CFR 812.5, the label must include “the name and place of business of the manufacturer, packer, or distributor (in accordance with 801.1), the quantity of contents, if appropriate, and the following statement: "CAUTION--Investigational device. Limited by Federal (or United States) law to investigational use." The label or other labeling shall describe all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions.” (Davis et al.)
10. Four source documents are: 1. Case Report Forms 2. AE & SAE Reporting 3. Informed Consent Process 4. Study Visits (Davis et al. )
11. MedDRA hierarchies: (Kulakowski & Chronister, 2008)
- system organ class
- high level group term
- high level term
`
- preferred term
Lowest level term
Works Cited:
Bio-definitions. (2012). Retrieved from http://www.biotechmedia.com/definitions-d.html
Davis, K., & Liu, M. Kulakowski, e., & chronister, l. (208). research administration and management. jones & bartlett learning.. Wiley.
Kulakowski, E., & Chronister, L. (2008). Research administration and management. Jones & Bartlett Learning.
