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.
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.
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 !