Guideline For Electronic Submission of Clinical Trial Documents (Amendments, Bioequivalence Studies, Responses, Notifications, And Serious Adverse Events)

Guideline For Electronic Submission of Clinical Trial Documents (Amendments, Bioequivalence Studies, Responses, Notifications, And Serious Adverse Events)

This guideline serves as a guide to applicants on the electronic submission process for major activities performed within Clinical Trials Unit (CTU).

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Download Version 2 (9.59)

Date updated

2022 Sept

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File Type: pdf
Category: Communication to industry, Guideline
Unit: Clinical Trials