Links a CTD table-of-contents heading to the document(s) placed under it. Module 1 codes are regionally defined; Modules 2-5 are ICH-defined.
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HA Controlled Vocabulary
Controlled Vocabulary / Code System Name as defoined by the Health Authority
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Term
Term Description as defined by the Health Authority
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Code
Code, if any, associated with the term by the Health Authority
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Agency
Name of the issuing Health Authority (abbreviation) that maintains the term and code
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Status
Current status of the Term usage as defined by the Health Authority (e.g., Current, Retired, Deprecated)
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| US Context of Use | m1.12.7 public disclosure statement for exception from informed consent for emergency research |
us_1.12.7
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FDA | — |
| US Context of Use | m1.12.8 correspondence regarding exception from informed consent for emergency research |
us_1.12.8
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FDA | — |
| US Context of Use | m1.12.9 notification of discontinuation of clinical trial |
us_1.12.9
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FDA | — |
| US Context of Use | m1.13.1 summary for nonclinical studies |
us_1.13.1
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FDA | — |
| US Context of Use | m1.13.10 foreign marketing |
us_1.13.10
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FDA | — |
| US Context of Use | m1.13.11 distribution data |
us_1.13.11
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FDA | — |
| US Context of Use | m1.13.12 status of postmarketing study commitments and requirements |
us_1.13.12
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FDA | — |
| US Context of Use | m1.13.13 status of other postmarketing studies and requirements |
us_1.13.13
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FDA | — |
| US Context of Use | m1.13.14 log of outstanding regulatory business |
us_1.13.14
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FDA | — |
| US Context of Use | m1.13.15 development safety update report (DSUR) |
us_1.13.15
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FDA | — |
| US Context of Use | m1.13.2 summary of clinical pharmacology information |
us_1.13.2
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FDA | — |
| US Context of Use | m1.13.3 summary of safety information |
us_1.13.3
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FDA | — |
| US Context of Use | m1.13.4 summary of labeling changes |
us_1.13.4
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FDA | — |
| US Context of Use | m1.13.5 summary of manufacturing changes |
us_1.13.5
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FDA | — |
| US Context of Use | m1.13.6 summary of microbiological changes |
us_1.13.6
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FDA | — |
| US Context of Use | m1.13.7 summary of other significant new information |
us_1.13.7
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FDA | — |
| US Context of Use | m1.13.8 individual study information |
us_1.13.8
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FDA | — |
| US Context of Use | m1.13.9 general investigational plan |
us_1.13.9
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FDA | — |
| US Context of Use | m1.14.1.1 draft carton and container labels |
us_1.14.1.1
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FDA | — |
| US Context of Use | m1.14.1.2 annotated draft labeling text |
us_1.14.1.2
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FDA | — |
| US Context of Use | m1.14.1.3 draft labeling text |
us_1.14.1.3
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FDA | — |
| US Context of Use | m1.14.1.4 label comprehension studies |
us_1.14.1.4
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FDA | — |
| US Context of Use | m1.14.1.5 labeling history |
us_1.14.1.5
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FDA | — |
| US Context of Use | m1.14.2.1 final carton or container labels |
us_1.14.2.1
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FDA | — |
| US Context of Use | m1.14.2.2 final package insert (package inserts patient information medication guides) |
us_1.14.2.2
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FDA | — |
Showing 51–75 of 380 terms . Data sourced from public health authority publications and updated periodically.