Sephton, Carmen Ling. / Thesis (M.Phil.)--Chinese University of Hong Kong, 2003. / Includes bibliographical references (leaves 127-144). / Abstracts in English and Chinese. / Chapter A. --- Acknowledgement --- p.ii / Chapter B. --- Abstract in English --- p.iii / Chapter C. --- Abstract in Chinese --- p.v / Chapter D. --- Table of Contents --- p.vii / Chapter E. --- List of Abbreviations --- p.xii / Chapter D. --- Table of Contents / Chapter 1. --- Introduction --- p.1 / Chapter 1.1 --- Basic background of TCM --- p.3 / Chapter 1.2 --- Choosing TCM Over Western Medication --- p.6 / Chapter 1.3 --- TCM Clinical Trials --- p.7 / Chapter 1.4 --- Evidence Based Medicine and Good Clinical Practice --- p.11 / Chapter 1.5 --- Outline of ICH GCP guidelines used for evaluation --- p.15 / Chapter 2. --- Aim and Objectives --- p.18 / Chapter 3. --- Method --- p.19 / Chapter 3.1 --- Rational for choosing the two studies for comparison --- p.21 / Chapter 3.2 --- Literature Search --- p.25 / Chapter 4. --- Method - Traditional Chinese Medicine clinical trial --- p.27 / Chapter 4.1 --- Protocol Development --- p.27 / Chapter 4.2 --- Consent Form Development --- p.28 / Chapter 4.3 --- Ethics Committee Submission and Approval --- p.29 / Chapter 4.4 --- Case Report Form Development --- p.29 / Chapter 4.5 --- Investigator Folder Development --- p.32 / Chapter 4.6 --- GCP Documentation Collection and Development --- p.33 / Chapter 4.6.1 --- Curriculum Vitae Collection --- p.33 / Chapter 4.6.2 --- Site Personnel Log --- p.34 / Chapter 4.6.3 --- Subject Screening Log --- p.34 / Chapter 4.6.4 --- Subject Identification Code List --- p.35 / Chapter 4.6.5 --- Subject Enrolment Log --- p.35 / Chapter 4.7 --- Medication --- p.36 / Chapter 4.7.1 --- Capsules --- p.36 / Chapter 4.7.2 --- Randomisation Code --- p.39 / Chapter 4.7.3 --- Labelling of Study Medication --- p.40 / Chapter 4.7.4 --- Storage --- p.40 / Chapter 4.7.5 --- Drug Accountability --- p.40 / Chapter 4.8 --- Investigator Brochure --- p.41 / Chapter 4.9 --- Monitoring --- p.41 / Chapter 5. --- Method - Western medication clinical trial --- p.42 / Chapter 5.1 --- Protocol Development --- p.42 / Chapter 5.2 --- Consent Form Development --- p.43 / Chapter 5.3 --- Ethics Committee Submission and Approval --- p.43 / Chapter 5.4 --- Case Report Form Development --- p.43 / Chapter 5.5 --- Investigator Folder Development --- p.44 / Chapter 5.6 --- GCP Documentation Collection and Development --- p.44 / Chapter 5.6.1 --- Curriculum Vitae Collection --- p.44 / Chapter 5.6.2 --- Site Personnel Log --- p.45 / Chapter 5.6.3 --- Subject Screening Log --- p.45 / Chapter 5.6.4 --- Subject Identification Code List --- p.45 / Chapter 5.6.5 --- Subject Enrolment Log --- p.45 / Chapter 5.7 --- Medication --- p.46 / Chapter 5.7.1 --- Tablets --- p.46 / Chapter 5.7.2 --- Randomisation Code --- p.46 / Chapter 5.7.3 --- Labelling of Study Medication --- p.47 / Chapter 5.7.4 --- Storage --- p.47 / Chapter 5.7.5 --- Drug Accountability --- p.48 / Chapter 5.8 --- Investigator Brochure --- p.48 / Chapter 5.9 --- Monitoring --- p.48 / Chapter 6. --- Results & Discussion --- p.49 / Chapter 6.1 --- Protocol Development --- p.49 / Chapter 6.2 --- Consent Form Development --- p.59 / Chapter 6.3 --- Case Report Form Development --- p.65 / Chapter 6.4 --- Ethics Committee --- p.67 / Chapter 6.5 --- Investigator Folder Development --- p.68 / Chapter 6.6 --- GCP Documentation --- p.68 / Chapter 6.7 --- Medication --- p.69 / Chapter 6.7.1 --- Study Medication --- p.69 / Chapter 6.7.2 --- Randomisation Code and Code Break Envelops --- p.71 / Chapter 6.7.3 --- Labelling --- p.71 / Chapter 6.7.4 --- Storage --- p.73 / Chapter 6.8 --- Investigator Brochure (IB) --- p.73 / Chapter 6.9 --- Monitoring Visits --- p.75 / Chapter 6.9.1 --- Source document verification --- p.76 / Chapter 6.10 --- Results of Literature Search --- p.80 / Chapter 7. --- Discussion --- p.95 / Chapter 7.1 --- Discussion on the implementation of GCP in the two clinical trials evaluated --- p.95 / Chapter 7.2 --- Role and Importance of the Study Monitor & Results of Source Document Verification --- p.99 / Chapter 7.3 --- Blinding & randomisation procedures --- p.103 / Chapter 7.4 --- Good clinical Practice & TCM clinical trials --- p.103 / Chapter 7.5 --- Performing Literature Search in Preparation for TCM Clinical Trials --- p.110 / Chapter 7.6 --- Standardisation of Herbs and GMP Issues --- p.112 / Chapter 7.7 --- TCM Medical Practitioner (Investigator) Selection --- p.116 / Chapter 7.8 --- Method of Diagnosis --- p.117 / Chapter 7.9 --- Randomisation & Blind Assessment (placebo or control treatment) --- p.118 / Chapter 7.10 --- Adverse Events in TCM Clinical Trials --- p.122 / Chapter 7.11 --- Other Issues or Considerations & Future Work to be Performed at the CPSU --- p.122 / Chapter 8. --- Conclusion --- p.125 / Chapter 9. --- Reference List --- p.127 / Chapter 10. --- Appendices --- p.145
| Identifer | oai:union.ndltd.org:cuhk.edu.hk/oai:cuhk-dr:cuhk_324490 |
| Date | January 2003 |
| Contributors | Sephton, Carmen Ling., Chinese University of Hong Kong Graduate School. Division of Medical Sciences. |
| Source Sets | The Chinese University of Hong Kong |
| Language | English, Chinese |
| Detected Language | English |
| Type | Text, bibliography |
| Format | print, xiii, 203 leaves : ill. ; 30 cm. |
| Rights | Use of this resource is governed by the terms and conditions of the Creative Commons “Attribution-NonCommercial-NoDerivatives 4.0 International” License (http://creativecommons.org/licenses/by-nc-nd/4.0/) |
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