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CDER DATA STANDARDS MANUAL |
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CDER DATA STANDARDS MANUAL |
FDA Data Element Number.
CDER Data Element Number. C-GEN-10302
Data Element Name. ECH Document Type
Description. ECH Document Type describes the major classification of correspondence that the electronic charge and history card will track.
Source. ECH users group.
Relationship.
FDA Specifications.
CDER Specifications. ECH Document Type shall consist of an alphanumeric term which has a maximum length restricted to 60 characters, and a corresponding alphanumeric code with a maximum length of 3 characters. The first character, either "I" or "N" refers to whether the code applies to IND's or NDA's, respectively.
FDA Approved Date.
CDER Approved Date. February 1, 2000
FDA Revised Date.
CDER Revised Date.
Data Values.
| NAME | DEFINITION | FDA CODE |
|---|---|---|
| NDA Incoming Correspondence | Literal | NC |
| IND Incoming Correspondence | Literal | IC |
| NDA Internally Generated Correspondence For Archiving | Literal | NIN |
| IND Internally Generated Correspondence For Archiving | Literal | IIN |
| NDA Internally Generated Outgoing Correspondence | Literal | NUX |
| IND Internally Generated Outgoing Correspondence | Literal | IUX |
| NDA Adverse Experience Reports | Literal | ND |
| NDA Final Printed Labeling After Approval | Literal | NFA |