It is appropriate to create new headings in the CSR and new Appendices for these topics. The Guideline provides for and focuses on Efficacy and Safety variables known at the time. Other topics should be well referenced in the CSR body and clearly identified in the Table of Contents. Current submission options include:
- Stand alone reports. These can be placed in “parallel” with the main clinical study report in the eCTD. For example, a clinical pharmacology study might have the clinical study report, a PK report, and an assay validation report. For an efficacy study with patient reported outcome (PRO) measures, there might be a PRO report. Each of these reports can be referenced under the same heading in the eCTD and placed alongside one another in the eCTD folder for that study. Be sure to clearly describe the nature of the information in the title of the document that is provided through the eCTD.
- In a region where study tagging files are used. It is recommended that a file tag option from the “valid values list” be used, for example, safety report, antibacterial, special-pathogen, etc. (see Specifications for Study Tagging Alternatively, if a file-tag that adequately describes the material you are planning to submit is not available, you may request that a new file-tag be made available. This request should be submitted to your regional authority. In the event that this change cannot be accommodated within your timeframe you may place the document with the main body of the report, i.e., the document would be tagged with the “study-report-body” file-tag. The nature of the information should be contained in the title of the document that is provided through the eCTD. Please refer to the most recent version of the “valid values list”, as it is periodically updated as changes are requested.
