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CDER DATA STANDARDS MANUAL |
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CDER DATA STANDARDS MANUAL |
FDA Data Element Number. None.
CDER Data Element Number. C-DRG-00902
Data Element Name. Phase 4 Fulfillment Category
Description. This standard provides for all Phase 4 study fulfillment categories. Phase 4 studies are post-marketing studies that are imposed upon a pharmaceutical firm as a condition for drug approval. Defining the various fulfillment categories for each study will permit CDER management to determine trend analysis.
Source. DHHS Office of Inspector General, "Postmarketing Studies of Prescription Drugs" dated November 1995.
Relationship. Phase 4 Commitment Category
FDA Specifications. None.
CDER Specifications. Phase 4 Category shall consist of an alphabetic term which has a maximum length restricted to 100 characters, with the comma and hyphen being the only punctuation permissible. Codes representing these Phase 4 Fulfillment Categories shall consist of two digits separated by a decimal.
FDA Approved Date. None.
CDER Approved Date. February 13, 1996.
FDA Revised Date.
CDER Revised Date. April 21, 1997.
Data Values.
| NAME | DEFINITION | FDA CODE |
|---|---|---|
| Study Not Begun, Will Begin in Future | Literal | 1.1 |
| Study Not Begun, Company Did Not Agree to Conduct Study | Literal | 1.2 |
| Study Not Begun, Company Awaiting Approval of Supplement | Literal | 1.3 |
| Study in Progress, Underway | Literal | 2.1 |
| Study in Progress, Report In Preparation | Literal | 2.2 |
| Study in Progress, Halted | Literal | 2.3 |
| Study in Progress, Perpetual | Literal | 2.4 |
| Report of Study Submitted, Deemed Adequate by FDA | Literal | 3.1 |
| Report of Study Submitted, Deemed Inadequate by FDA | Literal | 3.2 |
| Report of Study Submitted, No Adequacy Determination by FDA | Literal | 3.3 |
| Company Released from Commitment, Drug Not Marketed | Literal | 4.1 |
| Company Released from Commitment, Question Answered by Other Studies | Literal | 4.2 |
| Company Released from Commitment, Reason Unclear | Literal | 4.3 |
| Company Released from Commitment, Study Not Feasible | Literal | 4.4 |
| Company Released from Commitment, Study Fulfilled | Literal | 4.5 |
| Status Unknown, No Information | Literal | 5.1 |