News

• Update of CRMO-SOPs for Clinical Research (01 Oct 2021)
• Launch of Online Application Platform for Clinical Trial Insurance and Hospital Approval Application
• CRMC Annual Report 2020
• Launch of Online GCP Workshop (Recognized by TransCelerate BioPharma) (22 Feb 2021)
• Update of CRMO-SOP-020 and 028 (01 Sep 2020)
• CRMC Annual Report 2019
• Update of CRMO-SOPs for Clinical Research
• Report of Site Visit of Iron Mountain HK Ltd. (02 Dec 2019)
• New CRMO SOP on Disposal of Investigational Medicinal Product (CRMO-SOP-027), effective on 01 Dec 2019
• New CRMO SOP on Clinical Research Vendor Selection & Quality Management (CRMO-SOP-026), effective on 15 Jun 2019
• CRMC Annual Report 2018
• Update of CRMO-SOPs for Clinical Research
• Clinical Trial Related Agreements Review effective on 02 Jan 2019
• Updated CRMO SOP on Investigational Medicinal Product (IMP) management (CRMO-SOP-007), effective on 01 Jul 2018
• CRMO online GCP examination- All Year Round effective on 02 Jan 2018
• CRMC Annual Report 2017
• New CRMO SOP on CRMO Monitoring Service (Site Initiation) (CRMO-SOP-023)* (for CRMO internal use only), effective on 23 Oct 2017
• New CRMO SOP on CRMO Monitoring Service (Clinical Trial Monitoring) (CRMO-SOP-024)* (for CRMO internal use only), effective on 23 Oct 2017
• New CRMO SOP on CRMO Monitoring Service (Site Close-Out) (CRMO-SOP-025)* (for CRMO internal use only), effective on 23 Oct 2017
• Online GCP examination with new version of ICH-GCP E6 (R2) effective on 01 Sep 2017
• Clinical Research Registration at Public Registry (29 Aug 2017)
• New arrangement of CUHK- Clinical Trial Agreement, effective on 03 Aug 2017
• CRMO SOPs are now available on 5 different platforms (18 Jul 2017)
• New CRMO SOP on Quality Assurance Person: Responsibilities and Functions (CRMO-SOP-021), effective on 01 Apr 2017
• New CRMO SOP on Quality Assurance Reviews (CRMO-SOP-022), effective on 01 Apr 2017
• Updated CRMO SOP on Qualification & Responsibilities of Investigator (CRMO-SOP-004), effective on 01 Apr 2017
• CRMC Annual Report 2016
• 5 Updated CRMO SOPs on CRMO-SOP-003, 006, 007, 019, 020, effective on 01 Jun 2016
• Update of HA standard indemnity letter (effective from 01 Jan 2016): version Sponsor/University/HA (Jan 2016) and version Sponsor/HA (Jan 2016)
• HAHO Operations Circular No. 10/2015 - Charging Arrangements for Management of Investigational Medicinal Products for Company-sponsored Clinical Trials by Pharmacy
• New CRMO SOP on Inspection of Clinical Research Unit (CRMO-SOP-019), effective on 15 Jun 2015; and Clinical Research Inspection Team
• New CRMO SOP on Biological Sample Management (CRMO-SOP-020), effective on 01 Jun 2015
• Resuscitation Manual – Prince of Wales Hospital (Version 5.1, Jan 2015)
• Policy for Administration of Research Medication in In-patient Service (15 Apr 2015)
• New application procedure of Clinical Trial Certificate (effective on 6 Feb 2015): Guidance Notes and Drug Office Memo
• Resuscitation Manual – Prince of Wales Hospital (Version 5, Nov 2014)
• New CRP SOPs (effective on 01 Jan 2015)
• Standard Operating Procedure for Invited Overseas or Local (non-HA) Medical Practitioners to Practice in the Hospitals within NTEC, dated 13 Nov 2014
• New form for “Application for Conducting Clinical Trial/Research Involving Patients in NTEC” -- Effective from 1 Sep 2014
• New application procedure of Clinical Trial Certificate (effective on 01 May 2014)
• Sep 2013 –Harmonization and introduction of the CUHK-CREC Guidelines for Standard Operating Procedures (SOP) for Clinical Research at CUHK-NTEC Hospitals/clinics

Events

• Hospital Authority Basic Infection Control Training for CUHK Research Personnel, effective on 01 Sep 2020
• Webinar : Briefing of external archival service (05 Jun 2020)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 07 Feb 2020 Friday)
• Online Training of Declaration of Helsinki, effective on 02 Jan 2020
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 29 Nov 2019 Friday)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 18 Oct 2019 Friday)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 06 Sep 2019 Friday)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 12 Jul 2019 Friday)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 12 Apr 2019 Friday)
• One‐day Good Clinical Practice (GCP) Workshop for Investigators and Site Personnel: Poster (23 Mar 2019 Saturday)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 01 Feb 2019 Friday)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 16 Nov 2018 Friday)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 14 Sep 2018 Friday)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 13 Jul 2018 Friday)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 11 May 2018 Friday)
• Basic Life Support Training for research units: Poster (29 May 2018 (Tuesday))
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 06 Apr 2018 Friday)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 03 Mar 2018 Friday)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 02 Feb 2018 Friday)
• Advanced Cardiac Life Support Training:Poster (05 February 2018 Monday)
• Basic Life Support Training for research units: Poster (27 February 2018 (Tuesday))
• Med Talk: Drug Development from Bench to Bedside: Poster and Slides (12 Dec 2017 Tuesday)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 01 Dec 2017 Friday)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 03 Nov 2017 Friday)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 06 Oct 2017 Friday)
• Basic Life Support Training for research units: Poster (07 Dec 2017 Thursday)
• Basic Life Support Training for research units: Poster (21 Aug 2017 Monday)
• Monthly Clinical Research Induction Program (Start from Jul 2017): Poster (Re-run 01 Sept 2017 Friday)
• Basic Life Support Training for research units: Poster (17 May 2017 Wednesday)
• Sharing Section on Clinical Research Inspections: Poster and Slides (27 Mar 2017 Monday)
• Monthly Online GCP Examination (Start from Feb 2017!)
• Online GCP examination (12 Oct - 28 Oct 2016)
• Basic Life Support Training for research units: Poster (08 September 2016 Thursday)
• Experience Sharing on Multi-Disciplinary Clinical Research: Poster (28 July 2016 Thursday)
• CRMO SOP Training Workshop + Post CFDA Inspection Sharing: Poster and Slides (17 May 2016 Tuesday / 25 May 2016 Wednesday)
• Advanced Cardiac Life Support Training:Poster (21 October 2016 Friday)
• 2^nd Clinical Trial Management Workshop - Investigator-sponsored Trial (IST): Poster and Slides (05 May 2016 Thursday)
• Online GCP examination (01 Jun - 15 Jun 2016)
• Basic Life Support Training for research units: Poster (24 May 2016 Tuesday / 26 July 2016 Tuesday / 08 September 2016 Thursday)
• Free Clinical Trial Leaflet Ordering
• Online GCP examination (20 Jan - 03 Feb 2016)
• 1^st Clinical Trial Management Workshop - Investigator-sponsored trial (IST): Poster and Slides (09 Dec 2015 Wednesday)
• One‐day Good Clinical Practice (GCP) Workshop for Investigators and Site Personnel: Poster (07 Nov 2015 Saturday)
• Lunch Workshop on the Operation of CRMC website (16 Sep 2015 Wednesday)
• Basic Life Support Training for research units: Poster (06 October 2015 Tuesday / 08 December 2015 Tuesday / 08 March 2016 Tuesday)
• Clinical Trial Financial Management Workshop: Poster and Slides (14 Jul 2015 Tuesday)
• Launch of CRMO SOP online training platform
• CREC and CRMO Workshop on Clinical Trial Approval: Poster and Slides: Opening, CRMO Slides, CREC Slides (26 Jun 2015 Friday)
• Basic Life Support Training for research units: Poster (03 Mar 2015 Tuesday or 06 May 2015 Wednesday); One more class is opened on 27 Apr 2015 Monday
• One‐day Good Clinical Practice (GCP) Workshop for Investigators and Site Personnel: Poster and Agenda (07 Mar 2015 Saturday)
• Briefing of Clinical Research Pharmacy (CRP): Slides (21 Aug 2014 Thursday) (For further enquiry, please send to crmo@cuhk.edu.hk and the enquiry will be handled by CRP.)
• CRMO SOP Train-the-Trainer Workshop in NTEC hospitals: North District Hospital (01 Aug 2014), Cheshire Home Shatin (23 Jul 2014), Shatin Hospital & Bradbury Hospice (22 Jul 2014)
• Online GCP examination (24 Jul - 06 Aug 2014)
• External Archival Service Workshop (04 Jul 2014 Friday)
• Good Clinical Trial Practice : Introduction to ICH-GCP: Poster and Slides (03 Jul 2014 Thursday)
• CRMO SOP Train-the-Trainer Workshop: Poster and Slides (20 Feb 2014 Thursday / 26 Feb 2014 Wednesday)
• Press Conference for the Opening of the CUHK Phase 1 Clinical Trial Centre (P1CTC) (18 Dec 2013 Wednesday)
• CUHK-NTEC Clinical Research Forum – Safety Ethics and Quality (25 Oct 2013 Friday / 28 Oct 2013 Monday)

Newsletter

Issue 11, Dec 2018	Issue 10, Dec 2017	Issue 9, Jul 2017	Issue 8, Apr 2017
Issue 7, Nov 2016	Issue 6, Jul 2016	Issue 5, Feb 2016	Issue 4, Oct 2015
Issue 3, Jun 2015	Issue 2, Feb 2015	Issue 1, Sep 2014