State Institute for Drug Control

As from Jan. 10, 2013 the format was unified in accordance with the recommendation of the EMA Guidance – in the CZ it applies for all safety studies initiated after the effective date of the  Amendment to AoP. The final study report must be signed by the principal investigator and a copy of the report is to be archived for the reason of audits and inspections by the QPPV. The final study report shall contain the date of the study registration in the EU PAS register. It is recommended to state all the chapters in accordance to EMA Guidance (and indicate N/A for parts which are not applicable to the specific study) and the order/numbers of the chapters pursuant to the GVP.