View source for Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.2

{{ReferenceData
|has_document=Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024
|module=5
|unit=5.1.1
|scope=G
|doc_part=5.2
|language=EN
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00045-Adv-hte ++ TAG-00029-Inf-rte ++ TAG-00252-Exp-hle ++ TAG-00033-Pro-oto
|tags_display=[[Glossary:TAG-00045-Adv-hte|Adverse event]], [[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00252-Exp-hle|Expedited reporting]], [[Glossary:TAG-00033-Pro-oto|Protocol]]
|comment=Pre-treatment adverse events
|content=5.2 Pre-Treatment AEs
A pre-treatment adverse event is an adverse event that occurs after a participant has signed an informed consent, but before intervention has begun. 
Refer to the protocol document to determine routine and/or expedited reporting requirements.
}}