View source for Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 4.3

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{{:Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024}}

{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 5 — Unit 5.2.4
|-
! Scope
| G
|-
! Document part
| 4.3
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
| 
|-
! Tags
| [[Glossary:TAG-00252-Exp-hle|Expedited reporting]], [[Glossary:TAG-00253-Rep-att|Reporting timeline]], [[Glossary:TAG-00046-Ser-sSc|Serious adverse event]], [[Glossary:TAG-00011-Inv-tud|Investigational drug (IMP)]]
|-
! Comment
| Expedited AE (SAE) reporting timelines
|}

== Content ==
4.3 Expedited AE (i.e., SAE) Reporting Timelines

Appendices 1 and 2 detail the expedited reporting requirements for AEs that occur on trials utilizing an agent under an NCI IND/IDE or CIP Studies Using Commercial Imaging Agent(s). The report type/timelines are defined below:

• 24-Hour; 5 Calendar Day
o The SAE must initially be reported via CTEP-AERS within 24 hours of learning of the event, followed by a complete expedited report within 5 calendar days of the initial 24-hour report. This is a 2-step process.

• 24-Hour; 10 Calendar Day
o The SAE must initially be reported via CTEP-AERS within 24 hours of learning of the event. A complete expedited report on the SAE must be submitted within 10 calendar days of the investigator learning of the event.

• 15 Calendar Day
o A complete expedited report on the SAE must be submitted within 15 calendar days of the investigator learning of the event.