FDA has updated the guideline for Specifications for eCTD Validation Criteria (V3.8). In this version FDA updated;
- Descriptions of the eCTD Validation Criteria of Error Codes 1734, 1735, and 1736 which support the Study Data Technical Conformance Guide
| Error Code | In Previous Versions | In New Version 3.8 |
| 1734 | A Trial Summary (TS) dataset must be present for each study in module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4 and in module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 | A dataset named ts.xpt with information on study start date must be present for each study in module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 |
| 1735 | The correct STF file-tags must be used for all standardized datasets in module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4 and in module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 | The correct STF file-tags must be used for all standardized datasets and corresponding define.xml files in module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 |
| 1736 | DM dataset and define.xml must be submitted in module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4. DM dataset, ADSL dataset, define.xml must be submitted in module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 | For SEND data, a DM dataset and define.xml must be submitted in module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4
For SDTM data, a DM dataset and define.xml must be submitted module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 For ADaM data, an ADSL dataset and define.xml must be submitted in module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 |
- Severity of Error Codes 1735 and 1789
| Error Code | In Previous Versions | In New Version 3.8 |
| 1735 | Medium | High |
| 1789 | Medium
(A file has been submitted in a study section without providing an STF file) |
High
(A file has been submitted in a study section without providing an STF file. STFs are not required for 4.3 Literature references, 5.2 Tabular listings, 5.4 Literature references and 5.3.6 Post-marketing reports) |
- Deletion of Error Codes 1 and 5033
| Error Code | In Previous Versions | In New Version 3.8 |
| 1 | Duplicate eCTD sequence number | Deleted |
| 5033 | Missing application form | Deleted |
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