Application Forms

  1. Clinical Trial Insurance

  2. Hospital Approval

  3. External Archival Service

  4. Clinical Research Ethics Committee

  5. Clinical Trial Certificate


CRMO-SOP

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


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



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