1. ‘REC Guide’ internalizes Best Practices 1. ‘REC Guide’ internalizes Best Practices

HA Guide forCluster REC

Approved by HA REC:Approved by HA REC:• HA-wide Standards & basis for HA-wide Standards & basis for

harmonizing with CU & HKUharmonizing with CU & HKU• Guiding document for CRECsGuiding document for CRECs• Enables auditEnables audit

ICH GCP (E6)Other references,e.g. FDA IRB Guide

InternationalInternationalrequirementsrequirements& practices& practices

Applicable regulationsProfessional Codes

HA policy

Cluster REC Standard OperatingProcedure & Forms

Approved by CREC:Approved by CREC:• Guides operationGuides operation• Enables enforcement / Enables enforcement /

auditaudit

Local standards & practicesLocal standards & practices

Declaration of Helsinki

Local requirementsLocal requirements