Role of Investigator

1. Role of Investigator Start-up Meeting March 25, 2010 Kingston, ON

2. Role of Site Investigator • Delegation of Authority • Patient Eligibility • SAE identification & assessment • Hospital Acquired Infection Adjudication • Investigator Confirmation Details provided during SAE session Details provided during CRF session

3. Delegation of Authority The Investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties (ICH section 4.1.5) Completed log must be sent to CERU before start of trial

4. Document in Medical Chart Patient enrolled in CANTREAT study. Patient randomized to the study at hrs. Patient met all the inclusion criteria and none of the exclusion criteria. Eligibility confirmed with Dr. ______________. Consent obtained from _____________ (relationship to pt) on dd/mmm/yyyy athrs. All questions & concerns addressed with SDM at this time. Copy of consent given to SDM. Date/time of entry: ____________ Signature of writer: ____________ Sign Incl/Excl Worksheet Eligibility Confirmation • Should have documented confirmation from MD regarding patient eligibility OR Implementation Manual

5. SAE Identification & Assessment • Ensure adherence to reporting requirements & timelines • Provide causality assessment SAE Manual

6. Hospital Acquired Infection Adjudication Site Investigator to make determination of a newly acquired infection based on antibiotic and microbiology data Can be delegated to another MD Implementation Manual & CRF