CTFG publiceert bijgewerkte versie 'Recommendation related to contraception and pregnancy testing in clinical trials'
De Clinical Trials Facilitation and Coordination Group (CTFG) van de Heads of Medicines Agencies (HMA) heeft op 21 september 2020 een bijgewerkte versie 1.1 van de “Recommendation related to contraception and pregnancy testing in clinical trials“ gepubliceerd.
In versie 1.1. van de “Recommendation related to contraception and pregnancy testing in clinical trials' zijn de volgende aanpassingen aangebracht:
- "after the relevant systemic exposure to the medicinal product has ended for exposure to other types of genotoxicants than aneugenic compounds, the duration for applying highly effective contraception measures for women of childbearing potential, has been extended from 1 month to 6 months (one folliculogenesis cycle).
- the need for informing participants to seek advice about donation and cryopreservation of germ cells in line with this guidance prior treatment if applicable, has been added to the section on the need for sexual counseling of study subjects, e.g. in adolescents, which should be reflected in the protocol."
Download 'Recommendation related to contraception and pregnancy testing in clinical trials' (21 september 2020, Version 1.1)
Bron: HMA CTFG website