Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024: Difference between revisions
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Latest revision as of 14:15, 16 July 2026
| 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 | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.3 | G | 1.3 | EN | 1.3 Investigator Responsibility • Clinical investigators and ultimately the protocol Principal Investigator (PI) have the primary responsibility for A… |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4 | G | 1.4 | EN | 1.4 Sponsor Responsibility • It is the responsibility of the sponsor to submit an IND/IDE for clinical trials conducted with investigational agents/in… |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.1. | G | 2.1.1. | EN | 2.1.1. Adverse Event (AE or Adverse Experience): Any untoward medical occurrence associated with the use of a drug in humans, whether or not considere… |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.14. | G | 2.1.14. | EN | 2.1.14. Hospitalization (or prolongation of hospitalization): NCI defines hospitalization for expedited AE reporting purposes as an inpatient hospital… |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.2 | G | 2.1.2 | EN | 2.1.2. Attribution: An assessment of the relationship between the AE and the medical intervention. After naming and grading the event, the clinical in… |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.21. | G | 2.1.21. | EN | 2.1.21. Life-Threatening Adverse Event: Any SAE that places the subject, in the view of either the investigator or the sponsor (NCI), at immediate ris… |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.28 | G | 2.1.28 | EN | 2.1.28. Serious Adverse Event (SAE): Any adverse drug event (experience) occurring at any dose that results in ANY of the following outcomes: 1. Death… |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.32 - 2.1.34 | G | 2.1.32 - 2.1.34 | EN | 2.1.32. Suspected Unexpected Serious Adverse Reaction (SUSAR): An adverse event that occurs in a clinical trial participant, which is assessed by the … |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 4.3 | G | 4.3 | EN | 4.3 Expedited AE (i.e., SAE) Reporting Timelines Appendices 1 and 2 detail the expedited reporting requirements for AEs that occur on trials utilizin… |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.1 | G | 5.1 | EN | 5.1 Pre-existing Conditions (formerly referred to as Baseline AEs) A pre-existing medical condition identified on baseline assessment is not considere… |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.2 | G | 5.2 | EN | 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 int… |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.1 | G | 5.3.1 | EN | 5.3.1 Persistent AE
A persistent AE (e.g., chronic) is one that extends continuously, without resolution between treatment cycles/courses. Instructio… |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.2 | G | 5.3.2 | EN | 5.3.2 Recurrent AEs
A recurrent AE is one that occurs and resolves during a cycle/course of therapy and then reoccurs in a later cycle/course. Instru… |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.6.6.1 | G | 5.6.6.1 | EN | 5.6.6.1 Pregnancy • Although not an AE in and of itself, pregnancy as well as its outcome must be documented via CTEP-AERS. CTEP agrees to soliciting… |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 Appendix 1 | G | Appendix 1 | EN | Appendix 1: Expedited Reporting Requirements for NCI IND/IDE Agents Phase 0 Studies: Expedited Reporting Requirements for Adverse Events that Occur o… |
