Bioequivalence and Bioavailability Forum

Hi Joy,

❝ 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.

Usually, as per CRO's SOP on "General Screening of Volunteers and Registration in Volunteer Databank", volunteers will be registered and screened well in advance to the study period to have sufficient number of eligible volunteers in the CRO's volunteer databank. Volunteer registration and screening will be done after they signed in Informed Consent Form for Registration and General Screening. There is no need to have separate protocol for Volunteer's Registration and General Screening. However, the SOP and Informed Consent Document on Volunteer's Registration and General Screening should be approved by Independent Ethics Committee before implementation. Based on the fit volunteers pool in the volunteer databank, you can select volunteers and informed consent specific for a particular study will be provided to the selected volunteers and you can conduct the study without any time delay.

Priya.