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1. ‘REC Guide’ internalizes Best Practices. Local standards & practices. Approved by CREC: Guides operation Enables enforcement / audit. Cluster REC Standard Operating Procedure & Forms. Approved by HA REC: HA-wide Standards & basis for harmonizing with CU & HKU Guiding document for CRECs
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1. ‘REC Guide’ internalizes Best Practices Local standards & practices • Approved by CREC: • Guides operation • Enables enforcement / audit Cluster REC Standard Operating Procedure & Forms • Approved by HA REC: • HA-wide Standards & basis for harmonizing with CU & HKU • Guiding document for CRECs • Enables audit ICH GCP (E6) Other references, e.g. FDA IRB Guide HA Guide for Cluster REC International requirements & practices Applicable regulations Professional Codes HA policy Declaration of Helsinki Local requirements