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eCTD Granularity Best Practices

Granularity can refer to the level of hierarchy of the folders and files in the eCTD directory tree or the smallest unit of detail within the eCTD tree structure. Granularity specifically impacts the following areas of submission management:

  • Submission Maintenance – Because you can only replace entire documents in the eCTD, not sections or pages, your submission's initial granularity choices affect updates you’ll make over the application life cycle.
  • Submission Review – Choosing a lower level of granularity allows agency reviewers to locate specific information. However, in some cases, it may be easier for them to review a single document rather than a large volume of small documents.

The basic rule of thumb is that the granularity of paper and electronic submissions should be equivalent. Some changes in granularity may be necessary to facilitate ongoing life cycle management. If you need to submit amendments to your eCTD, take note that you must provide reviewers with clear, identifiable information so that they can review changes quickly and easily.

Best practices with respect to eCTD granularity include:

  1. Know the levels at which granularity is specified by the authorities and where flexibility is available to the sponsor. The main decisions are to be made around the QOS in Module 2, certain portions of Module 3 and the construction of study reports in Modules 4 and 5.
  2. Understand the advantages and disadvantages of increased granularity. Authoring in smaller sections streamlines future submission maintenance. However, it can also complicate review, approval and assembly processes. Consider how likely a document is to change over time before making your decisions. 
  3. Ensure that your electronic document management system supports your desired level of granularity. Your EDMS should allow you to classify documents at the desired levels and provide templates to assist your authors.

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