Glossaries
Glossaries
| Term | Definition |
|---|---|
| route of administration (ROA) |
Path by which the pharmaceutical product is taken into or makes contact with the body. [After ISO 11615:2017, 3.1.76] See also administration (substance), administrable dosage form.
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| role (CDISC classifier) |
Classifier for variables that describe "observations" in the SDTM. Role is a metadata attribute that determines the type of information conveyed by an observation-describing variable and standardizes rules for using the describing variable. [SDTM]
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| risk based monitoring |
A systematic, prioritized, risk-based approach to monitoring clinical trials. [After ICH E6(R2), 5.18.3]
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| risk |
In clinical trials, the probability of harm or discomfort for subjects. NOTE: Acceptable risk differs depending on the condition for which a product is being tested. A product for sore throat, for example, will be expected to have a low incidence of troubling side effects. However, the possibility of unpleasant side effects may be an acceptable risk when testing a promising treatment for a life-threatening illness.
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| RHIO (Regional Health Information Organization) |
A group of organizations with a business stake in improving the quality, safety and efficiency of healthcare delivery. RHIOs are the building blocks of the proposed National Health Information Network (NHIN) initiative.
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| retrospective study |
A study with planned observations collected predominantly before study start (i.e. backward-looking). Note: Examples are case-control studies or retrospective cohort studies when the observations from the selected subjects occurred before study start. [after ClinicalTrials.gov] See also prospective study, observational study, adaptive design, clinical study.
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| retrospective data capture |
Capture of clinical trial data is retrospective when it is recalled from memory rather than captured contemporaneously in real-time. NOTE: Retrospective capture is important in PROs because of "recall bias" and other errors documented in psychological research comparing contemporaneous self-reported assessments and those that rely on recall from memory.
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| results posting date (results submission date) |
The date and time the summary information about the results of the clinical study are submitted to a structured, publicly accessible, Web-based results database, such as the ClinicalTrials.gov results database. [ClinicalTrials.gov]
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| results posting (results submission) |
The process of submitting and updating summary information about the results of a clinical study to a structured, publicly accessible, Web-based results database, such as the ClinicalTrials.gov results database. [ClinicalTrials.gov]
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| result synopsis |
The brief report prepared by biostatisticians summarizing primary (and secondary) efficacy results and key demographic information.
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| response option |
One of several choices to be available for selection in response to a prompt, question or instruction (i.e., a stem) in a PRO item. See also common data element, stem.
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| residual risk |
In assessing the risk of re-identifying a trial participant, the risk that remains after controls are taken into account (the net risk or after controls). [Institute of Medicine report, Appendix B]
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| research hypothesis |
The proposition that a study sets out to support (or disprove); for example, "blood pressure will be lowered by [specific endpoint] in subjects who receive the test product." See also null hypothesis.
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| rescue medications |
Medicinal products identified in the protocol as those that may be administered to subjects when the efficacy of the investigational medicinal product (IMP) is not satisfactory, the effect of the IMP is too great and is likely to cause a hazard to the patient, or to manage an emergency situation. [After EU-CTR Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017]
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| report |
A document that presents information in a structured format intended for a specific purpose and recipient. See also final report, interim clinical trial/study report, monitoring report, document (HL7), clinical study (trial) report.
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