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Evaluation of traditional Chinese medicine clinical trials conducted in accordance to good clinical practice guidelines.

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

Identiferoai:union.ndltd.org:cuhk.edu.hk/oai:cuhk-dr:cuhk_324490
Date January 2003
ContributorsSephton, Carmen Ling., Chinese University of Hong Kong Graduate School. Division of Medical Sciences.
Source SetsThe Chinese University of Hong Kong
LanguageEnglish, Chinese
Detected LanguageEnglish
TypeText, bibliography
Formatprint, xiii, 203 leaves : ill. ; 30 cm.
RightsUse 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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