Guidance Document: Considerations for Inclusion of Women in Clinical Trials and Analysis of Sex Differences

Guidance Document: Considerations for Inclusion of Women in Clinical Trials and Analysis of Sex Differences This guidance addresses considerations regarding women of all ages, including women of child-bearing potential and women who are not of child-bearing potential as subjects in clinical trial research. Some of the issues addressed in this guidance may also be pertinent to adolescent girls who are subjects in clinical trial research. 2022-06-07 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyinclusion-of-women in clinical-trialsanalysis of sex-differencessubjects in clinical-trial-researchadolescent-girls subjects-in clinical-trial-research Guidance Document: Considerations for Inclusion of Women in Clinical Trials and Analysis of Sex DifferencesHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/considerations-inclusion-women-clinical-trials.html#a14 Guidance Document: Considerations for Inclusion of Women in Clinical Trials and Analysis of Sex DifferencesHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/produits-biologiques-radiopharmaceutiques-therapies-genetiques/information-demandes-presentations/lignes-directrices/considerations-relatives-inclusion-femmes-essais-cliniques-analyse.html#a14

This guidance addresses considerations regarding women of all ages, including women of child-bearing potential and women who are not of child-bearing potential as subjects in clinical trial research. Some of the issues addressed in this guidance may also be pertinent to adolescent girls who are subjects in clinical trial research.

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