Bioequivalence and Bioavailability Forum

Hi joy_fm,

❝ Is it allowed to create 2 type of protocol and informed consent, as follows:

❝ The first protocol (and informed concent) is made for subject recruitment of general BE studies, without specific information of investigational drugs mentioned in protocol.

❝ Second protocol (and informed concent) is made for specific BE studies.

❝ The main purpose of the first protocol (and informed concent) is to obtain subject pool. So when FDA approval of second protocol (and informed concent) has been obtained, we don't need to rush to get subject candidates, because we already have subject pool.

You do not need a protocol in order to create a subject database as long as this is just a list of subjects who has an interest in participating in studies. Once you start testing them you need the protocol though to deem them fit or not. Thus the answer depends on what you mean with "subject recruitment of general BE studies".