ICSR file updates:
1. Field A.1.FDA.16 (FDA Safety Report Type tag) will be a new mandatory regional data element for the electronic submission of ICSRs.
2. Added New value to B.4.k.1 and B.4.k.19 in section J
3. Added Submission Rules
Refer to the FDA update released in February 2021:
FDA Adverse Event Reporting System (FAERS) Electronic Submissions | FDA
Refer to the FDA’s document released in December 2020:
ICH E2B(R2) Technical Specifications Document for Electronic ICSRs – December 22, 2020 (fda.gov)
If you need assistance to prepare your Safety database for this upcoming change, our team of experts is here to help.
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