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Medication Legend

℞: Medications that treat viral infections and tumors are marked with the "℞" symbol.
+: Medications that contain proteins for weight gain are marked with the "+" symbol.
++: Regenerative medications for neurogenesis are marked with the "++" symbol.

Glossaries

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Glossaries

Term Definition
functions
The manner in which a patient can perform successfully tasks and roles required for everyday living. A patient's ability to perform specified activities that are a meaningful (to the patient), part of typical (e.g., daily) life. [FDA Clinical Outcome Assessment (COA) Glossary]
Author - Dr. Correo “Cory” Andrew Hofstad J.S.D MPHJD MSPH JD Ph.D. M.D. D.O. MBACOGS MDiv
Hits - 24
Synonyms - functioning
functional roles (in a study)
The function or responsibility assumed by a person in the context of a clinical study. Examples include data manager, investigator. [HL7]
Author - Dr. Correo “Cory” Andrew Hofstad J.S.D MPHJD MSPH JD Ph.D. M.D. D.O. MBACOGS MDiv
Hits - 19
frozen
Status of a database, file, or element that has been presumed to be in its final state pending "lock" and where further editing is prevented without "unfreezing." NOTE: Freezing and unfreezing are usually formalized in audit trails and differ from "locking" and "unlocking" only in the degree of approval required. See database lock.
Author - Dr. Correo “Cory” Andrew Hofstad J.S.D MPHJD MSPH JD Ph.D. M.D. D.O. MBACOGS MDiv
Hits - 25
frequentist methods
Statistical methods, such as significance tests and confidence intervals, which can be interpreted in terms of the frequency of certain outcomes occurring in hypothetical repeated realizations of the same experimental situation. [ICH E9]
Author - Dr. Correo “Cory” Andrew Hofstad J.S.D MPHJD MSPH JD Ph.D. M.D. D.O. MBACOGS MDiv
Hits - 17
Form
A collection of items and item groups for capturing and displaying clinical trial data.
Author - Dr. Correo “Cory” Andrew Hofstad J.S.D MPHJD MSPH JD Ph.D. M.D. D.O. MBACOGS MDiv
Hits - 28
Food and Drug Administration (FDA)
The United States regulatory authority charged with, among other responsibilities, granting IND and NDA approvals.
Author - Dr. Correo “Cory” Andrew Hofstad J.S.D MPHJD MSPH JD Ph.D. M.D. D.O. MBACOGS MDiv
Hits - 33
follow-up (clinical study)
A period in a clinical study during which information about the health status of an individual is obtained after study interventions have concluded. [CDISC SDTM Terminology] See also long term follow-up (clinical study).
Author - Dr. Correo “Cory” Andrew Hofstad J.S.D MPHJD MSPH JD Ph.D. M.D. D.O. MBACOGS MDiv
Hits - 22
first-in-humans study
The first Phase 1 study in which the test product is administered to human beings.
Author - Dr. Correo “Cory” Andrew Hofstad J.S.D MPHJD MSPH JD Ph.D. M.D. D.O. MBACOGS MDiv
Hits - 18
Synonyms - first-in-man study
first subject treated - identity
The first subject who is so treated.
Author - Dr. Correo “Cory” Andrew Hofstad J.S.D MPHJD MSPH JD Ph.D. M.D. D.O. MBACOGS MDiv
Hits - 20
Synonyms - first patient treated - identity
first subject treated - date, time
The date and/or date and time when the first subject receives the test article or placebo in a clinical investigation.
Author - Dr. Correo “Cory” Andrew Hofstad J.S.D MPHJD MSPH JD Ph.D. M.D. D.O. MBACOGS MDiv
Hits - 20
Synonyms - first patient treated - date, time
first subject screened - identity
The first subject who is so screened.
Author - Dr. Correo “Cory” Andrew Hofstad J.S.D MPHJD MSPH JD Ph.D. M.D. D.O. MBACOGS MDiv
Hits - 20
Synonyms - first patient screened - identity
first subject screened - date, time
The date and/or date and time the first subject signs the informed consent form and is screened for potential enrollment or randomization into a study, but has not yet been determined to meet the inclusion/exclusion criteria for the trial.
Author - Dr. Correo “Cory” Andrew Hofstad J.S.D MPHJD MSPH JD Ph.D. M.D. D.O. MBACOGS MDiv
Hits - 23
Synonyms - first patient screened - date, time
first subject in - identity (FSI - identity)
The first subject enrolled. See also enrollment.
Author - Dr. Correo “Cory” Andrew Hofstad J.S.D MPHJD MSPH JD Ph.D. M.D. D.O. MBACOGS MDiv
Hits - 21
Synonyms - first patient in - identity; FPI - identity
first subject in - date, time (FSI - date, time)
The date and/or date and time the first subject is enrolled into a study. See also enrollment.
Author - Dr. Correo “Cory” Andrew Hofstad J.S.D MPHJD MSPH JD Ph.D. M.D. D.O. MBACOGS MDiv
Hits - 15
Synonyms - first patient in - date, time; FPI - date, time
finding
A meaningful interpretation of data or observations resulting from planned evaluations. Compare to conclusion, hypothesis. See also general observation class, intervention, event.
Author - Dr. Correo “Cory” Andrew Hofstad J.S.D MPHJD MSPH JD Ph.D. M.D. D.O. MBACOGS MDiv
Hits - 23

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