SOP

  • Approval of SOP: This SOP is approved by the Chairman. The originally signed copy shall be kept by the Secretariat.

  • Review of SOP: This SOP will be reviewed by reviewer(s) delegated by the Chairman at least every three (3) years. Additional reviews may be performed as deemed required by the Chairman.

  • Updating of SOP: The Chairman will duly consider the recommendations by the reviewer(s) in order to finalize an updated   SOP. Whether or not any change is made to the SOP,

    • the version and review history at the front part of the SOP shall be updated;

    • the updated SOP shall be approved by the Chairman by signing on the cover page; and

    • the originally signed copy shall be kept by the Secretariat.

  • Guidelines and Working Manuals: HKCREC may, as it deems required, develop and maintain working manuals to supplement this SOP. The Secretariat shall have the authority to develop and approve working manuals. In the event of any conflict or inconsistency between a working manual and this SOP, this SOP shall prevail.

Registration with U.S. OHRP

As required under U.S. regulations, any organization that wishes to be involved in any clinical study funded by the U.S. federal government or any U.S. governmental agencies (e.g. the U.S. National Institutes of Health (“NIH”)) must use ethics committee(s)/institutional review board(s) registered with the OHRP for review and oversight of its clinical studies. HKCREC has registered with the OHRP.

Audits and Inspections

  • Responsibility to Facilitate Audits/Inspections: HKCREC will allow and facilitate audits by the inspections by competent regulatory authorities on HKCREC’s composition, operations and records on reasonable request. An audit/inspection will be performed by auditor(s) delegated or by inspector(s) delegated by the competent regulatory authority.

  • Preparation for Audits/Inspections: Any request for audit/inspection shall be made to the Chairman. Upon receipt of a request, HKCREC will:

    • verify the legitimacy of the request;

    • designate a person to take charge of the audit/inspection;

    • liaise with the auditing/inspection body on the scope, schedule and arrangements for the audit/inspection;

    • make all necessary documents, records and materials available for the audit/inspection; and

    • do other preparation as needed.

  • Facilitation of Audits/Inspections: During an audit/inspection, HKCREC will:

    • confirm the identity(ies) of the auditor(s)/inspector(s) at the start of the audit/inspection;

    • cooperate with the auditor(s)/inspector(s) to facilitate a smooth audit/inspection; and

    • monitor the auditing/inspection process and record any significant issue or finding from the audit/inspection.

  • Follow-up on Audits/Inspections: After completion of an audit/inspection, HKCREC will:

    • collect a written audit/inspection report from the auditor(s)/inspector(s);

    • respond to the auditing/inspection body on any issue or finding highlighted in the audit/inspection report;

    • take proper follow-up action(s) with respect to each issue or finding;

    • issue a follow-up report to the auditing/inspection body upon completion of all follow-up action(s) if so required by the auditing/inspection body; and

    • keep a complete record for the audit/inspection.

Research Ethics

Protection of study participants, science and data integrity are the three pillars of clinical research, and the benefits of study participants always come first.