| 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 |
|
|
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
|
CRMO-SOP-026 |
Nil |
|
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 |
|
SOP for Infection Control Training for Research Personnel in Clinical Areas
|
CRMO-SOP-028 |
Nil |