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Repeatable Sections and/or Studies

A
Written by Alondra Sandoval

Regulatory authorities allow the sponsor considerable freedom in determining how to structure some of the repeatable sections. For example, a sponsor may choose to provide a separate Section 3.2.S for each manufacturer of a drug substance or to provide a combined 3.2.S for all manufacturers, indicating manufacturer-specific documents by the leaf titles.

Once a repeatable section or study has been added, the metadata combination will be available for use in all future sequences in the same eCTD section. Using the Add Existing Repeat Sections checkbox in the Application Wizard will prepopulate all existing metadata. Additional information on automatically adding existing repeat sections can be found at the link above.

Once metadata has been submitted to a health agency, modifying sequence metadata results in multiple, separate repeat sections in the application. This can cause clarity issues during review and the lifecycle of the application as they are technically different sections, as shown below with the Danube vs Danube Mfg manufacturers:

Note: If section properties must be modified, all file references in the obsolete section must be deleted using lifecycle operator and re-submitted under the new/corrected section properties

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