Extension Type: General Folders
| Extension Type | Associated Attributes | Applied to Assembly Element | Result |
| Drug Substance folder |
— Substance — Manufacturer |
— 2.3.S Drug Substance folder — 3.2.S Drug Substance folder |
Creates the appropriate <m2-3-s-drugsubstance> and <m3-2-s-drugsubstance> elements in the XML with applicable attributes. Also builds the directory structure for 32s to include substance and manufacturer information. If the combination of substance and manufacturer information result in a folder or overall path length that is too long, the automatic creation of these folders can be overridden by populating the Output Folder attribute on the 3.2.S folder with an abbreviated value. The Output folder should be populated as follows: 32s-drug-sub/ sub-mfg, where the italicized information is the abbreviated value for the folder. |
| Drug Product folder |
— Product name — Manufacturer — Dosage form |
— 2.3.P Drug Product folder — 3.2.P Drug Product folder |
Creates the appropriate <m2-3-p-drugproduct> and <m3-2-p-drug- product> elements in the XML with applicable attributes. Also builds the directory structure for 32p to include product and dosage form information. If the combination of product and dosage form information result in a folder or overall path length that is too long, the automatic creation of these folders can be overridden by populating the Output Folder attribute on the 3.2.P folder with an abbreviated value. The Output folder should be populated as follows: 32p-drug-prod/prod-form, where the italicized information is the abbreviated value for the folder. |
| Extension Type | Associated Attributes | Applied to Assembly Element | Result |
| Clinical Indication folder | Indication |
— 2.7.3 Summary of Clinical Efficacy folder — 5.3.5 Reports of Efficacy and Safety Studies |
Creates the appropriate <m2-7-3summary-of-clinical-efficacy> and <5-3-5-reports-of-efficacy-andsafety-studies> in the XML with applicable attributes. Also builds the directory structure for m535 to include indication information. If the indication value results in a folder or overall path length that is too long, the automatic creation of this folders can be overridden by populating the Output Folder attribute on the 5.3.5 folder with an abbreviated value. The Output folder should be populated as follows: 535-rep-effic-safety-stud/ indication, where the italicized information is the abbreviated value for the folder. |
| Excipient folder | Excipient name | 3.2.P.4 Excipients |
Creates the appropriate <m3-2-p-4control-of-excipients> in the XML with applicable attributes. Also builds the directory structure for m32p4 to include excipient information. If the excipient value results in a folder or overall path length that is too long, the automatic creation of these folders can be overridden by populating the Output Folder attribute on the 3.2.P.4 folder with an abbreviated value. The Output folder should be populated as follows: 32p4-contr-excip/excipient-1, where the italicized information is the abbreviated value for the folder. |
| Quality Appendix folder |
— Manufacturer — Substance — Dosage form — Product name |
— 3.2.A.1 Facilities and Equipment — 3.2.A.2 Adventitious Agents |
Creates the appropriate <m3-2-a-1facilities-and-equipment> and <m3-2-a-2-adventitious-agentssafety-evaluation> with applicable attributes, and builds the directory structure to include manufacturer information. |
| Extension Type | Associated Attributes | Applied to Assembly Element | Result |
|
Quality Overall Summary folder |
No additional attributes |
2.3. Quality Overall Summary folder |
Used during XML creation to differentiate between the two eCTD elements that are both numbered 2.3 (2.3 Quality Overall Summary resulting in XML element <m2-3quality-overall-summary>, and 2.3 Introduction resulting in XML element <m2-3-introduction>). |
| Quality Introduction folder | No additional attributes | 2.3 Introduction folder | Used during XML creation to differentiate between the two eCTD elements that are both numbered 2.3 (2.3 Quality Overall Summary resulting in XML element <m2-3quality-overall-summary>, and 2.3 Introduction resulting in XML element <m2-3-introduction>). |
| Study Report folder |
— Full Report Title — Report Number — Operation — Species — Route of Administration — Duration — Type of Control |
In Assembly template for modules 2-5, applied to sample study report folders in sections 5.3.1.1 and 4.2.1.1. Should be applied to all study report folders as studies are added to the assembly. |
When applied to study folders in an assembly that is using the stf-2-2 XML definition file, triggers the creation of STF XML files for each study. The values provided as folder attributes are used to populate the <study-information> portion of the STF. All child leaf elements in the study report folder should have the leaf type of Study Report to capture their subject matter which is used to populate the <study-document> portion of the STF. The FDA has provided guidelines for which study types sponsors should provide information for species, route of administration, duration, and type of control. Studies under section 4.2.3.1 should include species and route of administration. Studies under section 4.2.3.2 should includes species, route of administration, and duration. Studies under section 4.2.3.4.1 should include species. Studies under 5.3.5.1 should include type of control. For all other study types, inclusion of this additional information in the study tagging files is optional. |
| Extension Type | Associated Attributes | Applied to Assembly Element | Result |
| Study Data folder |
— Dataset type — Subject Matter |
Individual Patient Data Listings folder included in the sample study report under section 5.3.1.1. This folder type should be used as the parent folder for all datasets, and the value for Dataset type is datasets-andassociated-files. The subfolders of the Individual Patient Data Listings folder also have this type applied with different values for the Dataset type attribute. |
Places the datasets in the location as specified by the FDA Study Data Specification (m5\datasets\study xx). This allows datasets to still be located in the assembly with the other study files, and referenced by the STF, but have them located in a different output location from the other study files. The value of the dataset type attribute dictates which subfolder the datasets should be placed in (analysis, tabulations, etc). |
| Study Patient Information folder |
— Subject Matter — Site |
Case Report Forms and Subject Profiles folders included in the sample study report under section 5.2.1.1. This folder type should be used as the parent folder for Case Report Form and Subject Profiles leaf elements to group them by site. |
Creates the additional <property> element in the STF with the attribute name="site-identifier" and uses the value for the Site attribute to populate the value of the <property> element. |
| Extension Type | Associated Attributes | Applied to Assembly Element | Result |
|
Node Extension folder |
No additional attributes |
This folder type is not applied to any folders in the assembly templates, but may be applied to folders if needed to create additional subheadings in the XML using the nodeextension concept. |
Creates a <node-extension> element in the XML using the name of the folder as the value for the <node-extension><title> element. This should be used only after consulting with the reviewing agency as some have indicated they do not want nodeextensions to be used. This folder type should only be applied to folders at the lowest level of the assembly as only the lowest level elements may be extended. |