Question regarding EudraCT forms and marketed products

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Morten

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Jan 19, 2010, 7:47:14 AM1/19/10
to Regulatory Affairs Professionals of Life Science
I have a question regarding section D2.4 in the EudraCT form.

D.2.4 states "Has the use of the IMP been previously authorised in a
clinical trial conducted by the sponsor in the Community ?" For
marketed products the answer is obviosuly "yes", however traditionally
we have always ticked "no" in order not to have to specify in which
member states. One option would be to leave the field black, However
when looking at the validation guide the field is mandatory. So my
question is what to put there, if anything, and why?

Thanks in advance

Morten

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