Certain sections of the TOC are repeated based on property values that can be supplied for a sequence. These are considered to be Repeat/Repeatable Sections. Repeatable sections are displayed in Publish and Review (desktop-based) as TOC folders, with the metadata required to build the section(s) in brackets.

Indicating that before adding documents to this section you would have to populate a Substance and a Manufacturer metadata

The following figure illustrates section 3.2S and how repeatable sections appear for an application containing multiple drug substance and manufacturer combinations.

See the following sections for more information

Add a Repeatable Section

Add a Study

Modify a Repeatable Section or Study

Remove a Repeatable Section or Study

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In order to meet granularity requirements for sections such as 3.2.S, 3.2.P, etc., specific sequence metadata must be added to Publish to build out the structure per combination.

Select the parent section in the tree and, in the Details pane, select the Sections tab.

Choose the section to create from the dropdown list.

Note: If you do not see the correct section to create, ensure the correct parent section in the tree has been selected.

Publish will prompt you to supply the properties for the selected section. Required fields are marked with an asterisk (*). For example, 3.2.S requires a Substance and Manufacturer, as shown below.

Note: Some fields are limited to values chosen from a list of controlled terms. If a required value is not in the list, contact your Publish administrator to have the term added (see the “Add Values via the Sections Properties Tab” section). In some cases, list values are dictated by a regulatory authority and cannot be added or modified.

After supplying all of the required properties for the new repeatable section, click Create to create the new section. The new repeatable section will then appear as a section (folder), along with the required subsections.

The example below shows repeatable sections under 3.2.S for:

Note: You must add a repeatable section by supplying properties even if you will only be using the section once.

For US submissions, each study is added to the output via a separate XML called a Study Tagging File, or STF. During the publishing of a sequence, Publish automatically generates a Study Tagging File in accordance with US FDA regulations using the sponsor-supplied metadata for the study.

For EMEA, Swissmedic, TGA and most Health Canada submissions, Study Tagging Files are not accepted. These regions use Section Extensions or Node Extensions to organize study data instead. Although the output structure may be slightly different, Publish still takes advantage of the Sections tab, generating compliant Node Extensions based on supplied metadata to organize group studies in accordance with the specific CTD/eCTD guidance.

Detailed information on Sections Extensions can be found in the “Non-STF Study Node Extensions” section later in this guide.

GlobalSubmit uses the same concept of a repeatable section to manage the creation of each STF or Section Extensions, see the “Add Application Metadata Repeatable Sections” section.

Repeatable Sections for additional information. As you can see below, studies use the same brackets to signify that sequence metadata must be added.

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A specific set of information, or submission metadata is required to organize the studies, a study id and a study title. This can be used in combination with other properties, such as Species and/or Route of Administration, as shown in the screenshot below.

For studies without additional properties, simply click on the study type folder (for example, 4.3.1.3 Safety Pharmacology). When you choose the Sections tab, you will be able to enter the Study ID and Title as shown in the following:

The following screenshot shows a section/folder that was added to represent study TOX2006-010 under the rat- intramuscular property group for 4.2.3.1 Single-Dose Toxicity studies

For clinical studies, including Case Report Forms (CRFs) and/or subject profiles, additional sections may also be added for each study site where one or more CRFs or subject profiles originated.

Add the appropriate site sections by choosing the study and adding a repeatable section within the section for each required site as shown in the following image.

Or, click directly on the Case Report Forms or Subject Profile folder and create the site as shown in the following image.

Certain categories of studies require additional properties such as:

For these studies, you must first supply the repeat section metadata as shown in the next image. These repeat sections are required to be able to add a study ID and study title.

Completing this step will result in the generation of a new section in the TOC.

To create a study, select the section under which the study will appear in the tree and choose the Sections tab. For the purpose of this example, the selected section is 5.3.1.1, Bioavailability Study Reports.

If the study requires more properties, you will be prompted to add them. Once completed, select the newly generated section representing the property values that you chose that will appear underneath the study section and enter the Study ID and Title.

Click Create. A new section will be created for the study, using the ID and Title

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To modify a repeatable section or study, choose the repeatable section in the tree and select the Repeatable Section tab. Modify the properties, click Save Changes, and confirm your changes.

Note: For sequences in eCTD format, changing a repeatable section’s properties will only affect in- process sequences. Otherwise, a new repeatable section must be added.

If the sequence has been finalized or submitted using original/incorrect property values and a change is made using new sections, reviewers will see multiple sections instead of the single, corrected section.

For example, if, in Sequence 0000, you used a drug substance manufacturer combination of Reox - Danube and later, in Sequence 0004, added the same substance, but a manufacturer of Danube Mfg, reviewers will see documents spread across two sets of 3.2.S sections, as shown in the following image, where 3.2.S.2 appears in both sections.

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A repeatable section or study may only be removed if it contains no content (file references or Section (Node) Extensions) in the sequence to remove, or any other sequences in the application.

To remove a repeatable section, choose the repeatable section in the tree, select the Sections Tab, click Remove, and confirm the deletion.