REFERENCES

GUIDELINES

USM

1. Guideline of Reporting SAE

2. COI and Vulnerable Glossary

3. Guideline for Whole Genome/ Genetic Studies USM

 

National

1. National Guideline for Haemopoietic Stem Cell Therapy (2009)

2. Malaysia Guideline for Bioequivalence Inspection - 1st Edition Oct 2014

3. Malaysian Guideline for Safety Reporting of Investigational Products, 1st Edition - October 2014

4. Malaysian Guideline for Independent Ethics Committee Registration and Inspection 1st Edition - May 2016

5. Malaysian Guideline for Phase 1 Unit Inspection and Accreditation Programme - Jun 2018

6. Malaysian Guideline for Good Clinical Practice (GCP) Inspection - Edition 2.1 (2020)

7. Malaysian Guideline for Good Clinical Practice (GCP) - 4th Edition (2018)

8. Malaysian Guideline for Application of CTIL and CTX - 7.1 Edition (2021)

9. Guidelines for Stem Cell Research and Therapy (2009)

10. National Standards for Stem Cell Transplantation (2018)

 

International

1. Belmont Report Vol 11

2. Operational Guidelines for Ethics Committees That Review Biomedical Research (WHO 2000)

3. Declaration of Helsinki Nov_2013

4. Guideline for Good Clinical Practice (GCP) ICH - E6(R2) Nov 2016