Ethics & Governance Documents required for contract execution: ✔ Protocol ✔ Investigator Brochure ✔ Pharmacy Manual ✔ Laboratory Manual ✔ Imaging Manual (if applicable) Documents required for RGO submission include: ✔ Full HREC approval ✔ PE CTRA ✔ Indemnity ✔ Certificate of Currency ✔ Site Specific Clauses