Pre SIV Activities

Collection of essential documents

• Calibration Certificates
• All applicable SOPs (Ethics Committee, Site, Lab, etc)
• Investigator and other study staff CV, MRC, and other certificates.
• Lab Head CV.
• Lab accreditation certificate, Lab Reference Ranges
• FDA 1572/Investigator undertaking (IU)
• Financial discloser agreement
• Site contact list
• Investigator Agreement
• Any other trial related document needed at SIV

Prepare site for SIV (Site initiation visit), to ensure:

• Availability of site personnel
• Availability of calibrated instruments (ECG, Sphygmomanometer, Stethoscope, Thermometer, Weighing machine etc.)