Report updates

E2B report form generates report using the FDA E2B(R2) 2.2 DTD profile. The following features are common to the FDA E2B(R2) 2.2 DTD profile and the existing FDA E2B(R2) 2.1 DTD profile:

• ICSR viewer
• ICSR check
• ICSR length check
• ICSR transmission
• Mark as submitted
• ICSR acknowledgement receipt
• ICSR attachments
• Time-out

The MedWatch and CIOMS view displays only the elements that are available for the FDA E2B 2.1 DTD profile.

PSUR and CTPR periodic reports send ICSRs using the FDA E2B(R2) 2.2 DTD profile, if you select the corresponding reporting destination in the Report Selection screen.

Reports submitted using the FDA E2B(R2) 2.2 DTD profile are considered in the following sections of NDA:

• Line listing of 15-day reports submitted.
• Cases sent to FDA under a different NDA.
• Listing of Nullified 15 day Alert Cases Submitted during the Reporting period.