Inquiry: Female Partner Pregnancy Reporting in Non-IMP Trials

[FONT=tahoma][COLOR=#61646b]Hello,
[/COLOR][/FONT][COLOR=#1F1F1F][FONT=&quot][FONT=tahoma]I am writing to seek clarification on the reporting requirements for pregnancies in female partners of male participants enrolled in non-investigational medicinal product (IMP) trials.[/FONT][/FONT][/COLOR]
[COLOR=#1F1F1F][FONT=&quot][FONT=tahoma]While the Clinical Trials Guidance for Investigators (CTFG) specifies that contraception is not mandatory for male subjects in non-IMP studies, my current protocol requires male participants to use condoms and their female partners to utilize contraception. Additionally, it mandates reporting of any female partner pregnancies.[/FONT][/FONT][/COLOR]
[COLOR=#1F1F1F][FONT=&quot][FONT=tahoma]Given the absence of an IMP-related risk, I would appreciate guidance on the necessity of these measures in my non-IMP protocol. Could anyone please provide any relevant MHRA source evidence that would support amending the protocol to remove these requirements?

Many thanks ![/FONT][/FONT][/COLOR]
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