Bioequivalence and Bioavailability Forum

Dear Mr Kaushik panigrahi,

Most of the Indian CROs have either 21 days or 28 days as Screening validity period in their SOP. Since, most of laboratory investigations done during the screening period will not change drastically within a period of 28 days, the validity for Screening Lab Report was kept as 28 days maximum validity period. However, during the Check in period, while performing the clinical examination, if the Investigator finds anything abnormal and if he wants to repeat the laboratory investigations to confirm the clinical findings, the lab reports will be repeated within a period of 28 days. This procedure of repeating the screening lab parameters by Investigator within a period of 28 days need to be captured in your SOP.

None of the Regulatory Guidance specify about the screening validity period.