What You Need to Complete Before Starting Study Specific Tasks

 Step 1: Study Training Log v2.0

• Train on SIV all documents listed 
• Fill in correct versions header
• Sign Date

 Step 2: CV & GCP

• CV: sign with wet ink or time-stamp e-signature date 1st CV within 1 year and renew it every 2 years within 2 pages
• GCP:  within 2 years (or 3 years if local policy)

 Step 3: Delegation Log v2.0

• Site staff signature PI initials 

 

If Randomisation Access Needed

Step 4: Train on Randomisation User Training v1.0 

Step 5: Complete Randomisation Users Training log & Access Request Form v2.0

• Initial & Date of Research Nurse /Delegate Conducting Training 
• Signature & Date of Randomisation User

 

If staff was delegated task on OpenClinica

Step 6: Complete OpenClinica Training 4.0

• Select relevant module (PI or Data entry)
• Password CDSTraining_123
• Save the certificate before closing the page

Step 7: OpenClinica UAF

• Fill in personal detail, study name, role,  site name
• Sign Date the form