Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.6.6.1
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| 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 5.4.4 |
| Scope | G |
| Document part | 5.6.6.1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Pregnancy, Adverse event, ICSR, Trial participant |
Content
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 information about pregnancy outcomes only from the study participant without approaching the partner for consent. The investigator will make best efforts to collect the de-identified information as outlined in the CTEP Clinical Trial Pregnancy Information Form (July 2024) only from the study participant via the study site.
• Because participants who become pregnant during the study risk intrauterine exposure of the fetus to agents which may be teratogenic, NCI is requesting that pregnancy be reported in an expedited manner via CTEP-AERS within 24-48 hours of awareness as Grade 3 “Pregnancy, puerperium and perinatal conditions - Other (pregnancy)†under the Pregnancy, puerperium and perinatal conditions SOC.
• In the event a male Study participant impregnates a non-participant female, NCI is requesting that pregnancy be reported in an expedited manner via CTEP-AERS within 24-48 hours of awareness as Grade 3 “Pregnancy, puerperium and perinatal conditions - Other (pregnancy)†under the Pregnancy, puerperium and perinatal conditions SOC.
• The pregnancy outcome for participants on-study should be reported via CTEP-AERS as an amendment to the previous report within 24-48 hours of the time the outcome becomes known, accompanied by the same Pregnancy Report Form used for the initial report. Please see the note above (Section 5.6.6) for how to submit the form.
• CTEP agrees to consent only the study participants and not the pregnant partner for reporting pregnancy and pregnancy outcome. Only when an investigator is made aware of any pregnancy occurring in a patient or patient’s partner from the time of consent to 90 days after the last dose of the study drug, should it be reported and then followed for outcome. Newborn infants should be followed until 30 days old.
