Application Forms

  1. Clinical Trial Insurance

  2. Hospital Approval

  3. External Archival Service

  4. Clinical Research Ethics Committee

  5. Clinical Trial Certificate


SOP SOP Ref no. Attachment

SOP for Preparation, Issue and Revision of SOP

CRMO-SOP-001 Attachment A - CUHK-NTEC-CRMO SOP Template

SOP for Conduct of Clinical Trial

CRMO-SOP-002 Attachment A – Checklist for CRMO-SOP-002 on initiation of clinical trial
Attachment B - Checklist for CRMO-SOP-002 on completion of clinical trial
Attachment C – Template of Monitoring/ Audit Visit Log

SOP for Application of Clinical Trial Certification from Department of Health

CRMO-SOP-003 Attachment A: Sample of “Letter of Intent”
Attachment B: Sample of Cover Letter with Acknowledgement of Receipt
Attachment C: Sample of Inquiry Letter if required

SOP for Qualification and Responsibilities of Investigator

CRMO-SOP-004 Attachment A - Summary of Responsibilities of Principal Investigator

SOP for Qualification and Responsibilities of Research Nurse

CRMO-SOP-005 Attachment A –Summary of Responsibilities of Research Nurse

SOP for Study Document Filing, Retention and Storage

CRMO-SOP-006 Attachment A – Checklist for Investigator Site File (ISF) of PI file
Attachment B – Template of Document Archive Log

SOP for Investigational Medicinal Product (IMP) Management

CRMO-SOP-007 Attachment A– Template of clinical trial specific IMP order form
Attachment B – Template of IMP Log
Attachment C – Template of IMP temperature and humidity log
Attachment D –Medication Administration Record (MAR)

SOP for Application for Ethics Approval by the Joint CUHK-NTEC-CREC

CRMO-SOP-008 Nil

SOP for Communication with Joint CUHK-NTEC-CREC

CRMO-SOP-009 Nil

SOP for Documentation of Qualification, Training and Delegation of Study Duties

CRMO-SOP-010 Attachment A – Template of Training Log
Attachment B – Template of Log of Delegation of Duty

SOP for Reviewing and Obtaining Informed Consent

CRMO-SOP-011 Nil

SOP for Source Documentation

CRMO-SOP-012 Attachment A: Chapter VIII – Retention of Medical Records. Manual of Good Practices in Medical Records Management, HAHO

SOP for Clinical Management System (CMS) use in Clinical Trials

CRMO-SOP-013 Attachment A – Summary of CMS use in Clinical Trials

SOP for Case Report Form (CRF) Completion

CRMO-SOP-014 Nil

SOP for Adverse Events (AEs) & Serious Adverse Events (SAE) Reporting

CRMO-SOP-015 Nil

SOP for Preventing and Managing Injuries and Emergencies in Clinical Research

CRMO-SOP-016 Attachment A: Summary of SAE & AIRS reporting

SOP for Resuscitation in Clinical Research

CRMO-SOP-017 Attachment A - Summary of Events requiring Resuscitation

SOP for Hospital Approval on Clinical Studies

CRMO-SOP-018 Attachment A – Application for Conducting Clinical Trial /Research Involving Patients in NTEC (Jun 2016) pdf doc

SOP for Inspection of Clinical Research Unit

CRMO-SOP-019 Attachment A – Inspection Checklist of Clinical Research Unit
Attachment B – Grading and Categories of Inspection Findings

SOP for Biological Sample Management

CRMO-SOP-020 Attachment A – Biological Sample Log (template)
Attachment B – Mapping template

SOP for Quality Assurance Person: Responsibilities and Functions

CRMO-SOP-021 Nil

SOP for Quality Assurance Reviews

CRMO-SOP-022 Attachment A- Grading and Categories of Quality Assurance Review Findings
Attachment B- Quality Assurance Checklist

CRMO Monitoring Service (Site Initiation)* (for CRMO internal use only)

CRMO-SOP-023 Attachment 1 - Site Initiation Visit Report

CRMO Monitoring Service (Clinital Trial Monitoring)* (for CRMO internal use only)

CRMO-SOP-024 Attachment 1 - Monitoring Visit Report

CRMO Monitoring Service (Site Close-Out)* (for CRMO internal use only)

CRMO-SOP-025 Attachment 1 - Site Close Out Visit Report

SOP for Clinical Research Vendor Selection and Quality Management


SOP of Disposal of Investigational Medicinal Product* (for CRMO internal use only)

CRMO-SOP-027 Attachment A- Template of Disposal of Pharmaceutical Waste List.pdf
Attachment A- Template of Disposal of Pharmaceutical Waste List.xls
Attachment B- IMP Transfer Log.pdf
Attachment B- IMP Transfer Log.xlsx

Standard Templates of Indemnity for Clinical Trial

Template Current Version (To be used from& 01 Jan 2016)
• Sponsor /Hospital Authority (HA) Sponsor/HA (Jan 2016)
• Sponsor /University /HA Sponsor /University /HA (Jan 2016)

Joint CUHK-NTEC Clinical Research Management Office

The Chinese University of Hong Kong, Hospital Authority New Territories East Cluster,
Joint CUHK-NTEC Clinical Research Management Committee and the Clinical Research Management Office © 2017. All Right Reserved