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30th Mar 2015, 03:41 PM
#1
Pregnancy testing not included in the protocol
Hi,
Has anyone come across a CI not adding pregnancy testing under the list of trial assessments due to "it's inappropriate to do so for some patients due to religious reasons"? The IMP under study does have potential to cause foetal abnormalities and the sites are expected to inform patients of proper contraceptive measures however it is not a requirement for patients to undergo pregnancy testing either at screening or while on study. This seems somewhat wrong to me but happy to be corrected.
Thanks!
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