Compliance of French academic clinical trials with the Clinical Trial Facilitation and Coordination Group recommendations on contraception and pregnancy testing requirements

Background/Aims The Clinical Trials Coordination and Facilitation Group has issued recommendations on contraception and pregnancy testing to help sponsors meet regulatory expectations and harmonize practices to limit embryofetal risks in clinical trials. Our objective was to assess the compliance of...

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Veröffentlicht in:	Clinical trials (London, England) England), 2020-06, Vol.17 (3), p.314-322
Hauptverfasser:	Crepin, Sabrina, Chiffoleau, Anne, Gavard, Marylaure, Olivier-Abbal, Pascale, Roussillon, Caroline, Ruault, Sophie, Muller, Charlotte, Peyro-Saint-Paul, Laure, Ouk, Thavarak, Franceschi, Marie-Paule, Mouchel, Catherine, Duranton, Sophie, Petitpain, Nadine, Coubret-Dumas, Anne
Format:	Artikel
Sprache:	eng
Schlagworte:	Adult Birth control Clinical trials Clinical Trials as Topic - methods Confidence intervals Contraception Contraception - statistics & numerical data Coordination Cross-Sectional Studies Drugs Exposure Female France Guideline Adherence - statistics & numerical data Humans Life Sciences Male Medical research Practice Guidelines as Topic Pregnancy Pregnancy Tests - statistics & numerical data
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