Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.1

Document information
Reference	USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024
Validity area	USA
Scope(s)	G
Document name	NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs
Version / Revision	30-Aug-2024
Status	Current
Document type	Other
Language(s)	EN
Description	National Cancer Institute GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 5 — Unit 5.1.1
Scope	G
Document part	5.1
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Adverse event, Baseline visit, AE severity, Requirements
Comment	Pre-existing conditions as baseline AEs

Content

5.1 Pre-existing Conditions (formerly referred to as Baseline AEs) A pre-existing medical condition identified on baseline assessment is not considered an AE and should not be reported as a routine or expedited AE. The baseline AE must be re-assessed throughout the study and reported if it fulfills expedited AE reporting guidelines:

  1. If the pre-existing condition worsens in severity, the investigator must reassess the event to determine if an expedited report is required (refer to Appendices 1 and 2). Whether or not an expedited report is required, the worsened event should be reported as a routine AE.

  2. If the AE resolves and then recurs, the investigator must re-assess the event to determine if an expedited report is required (refer to Appendices 1 and 2). Whether or not an expedited report is required, the recurrent event should be reported as a routine AE.

For example: In a clinical situation when a participant enters a study utilizing an agent under a CTEP IND/IDE with Dyspnea equivalent to CTCAE grade 1.

ROUTINE reporting of grade 1 Dyspnea is not required. If it increases in grade, it should be reported as a routine AE and evaluated for expedited reporting.

EXPEDITED reporting requirements (See Appendices 1 and 2) depend on:

  • If the Dyspnea remains unchanged while on study, a CTEP-AERS report is NOT required.
  • If at any time on study the Dyspnea results in hospitalization and/or prolongation of hospitalization, a CTEP-AERS report is required regardless of grade, expectedness and attribution (unless the AE is listed on the SPEER at or above the grade experienced by the participant).
  • If at any time while on study the Dyspnea value increases in grade and meets seriousness criteria, an expedited report is required (unless the AE is listed on the SPEER at or above the grade experienced by the participant).
  • If the investigator determines that the Dyspnea is expected as defined by the protocol, at or below the grade listed on the SPEER, an expedited report is NOT required.