DATA STANDARDS MANUAL |
FDA Data Element Number.
CDER Data Element Number. C-DRG-00916
Version Number. 001
Data Element Name. Geriatric Use Supplement Safety/Adverse Reaction Category
Description. Geriatric Use Supplement Safety/Adverse Reaction Category describes the safety and adverse reaction categories that are applicable to CDER Geriatric Use Supplements.
Source. Form FDA 3437.
Relationship.
FDA Specifications.
CDER Specifications. Geriatric Use Supplement Safety/Adverse Reaction Category shall consist of an alphanumeric term which has a maximum length restricted to 240 characters, and a corresponding alphanumeric code with a maximum length of 3 characters. (Reference table column_id = ger_use_sup_safety)
FDA Approved Date.
CDER Approved Date. February 1, 2000
FDA Revised Date.
CDER Revised Date.
Data Values.
NAME | DEFINITION | FDA CODE |
---|---|---|
CLINICAL EFFICACY TRIALS, RAW DATA AND STUDY ANALYSIS | Literal | CR |
CLINICAL EFFICACY TRIALS, LITERATURE | Literal | CL |
ANECDOTAL REPORTS, MEDWATCH / FORM 3500 | Literal | AM |
ANECDOTAL REPORTS, LITERATURE | Literal | AL |