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.iiChapter B. --- Abstract in English --- p.iiiChapter C. --- Abstract in Chinese --- p.vChapter D. --- Table of Contents --- p.viiChapter E. --- List of Abbreviations --- p.xiiChapter D. --- Table of ContentsChapter 1. --- Introduction --- p.1Chapter 1.1 --- Basic background of TCM --- p.3Chapter 1.2 --- Choosing TCM Over Western Medication --- p.6Chapter 1.3 --- TCM Clinical Trials --- p.7Chapter 1.4 --- Evidence Based Medicine and Good Clinical Practice --- p.11Chapter 1.5 --- Outline of ICH GCP guidelines used for evaluation --- p.15Chapter 2. --- Aim and Objectives --- p.18Chapter 3. --- Method --- p.19Chapter 3.1 --- Rational for choosing the two studies for comparison --- p.21Chapter 3.2 --- Literature Search --- p.25Chapter 4. --- Method - Traditional Chinese Medicine clinical trial --- p.27Chapter 4.1 --- Protocol Development --- p.27Chapter 4.2 --- Consent Form Development --- p.28Chapter 4.3 --- Ethics Committee Submission and Approval --- p.29Chapter 4.4 --- Case Report Form Development --- p.29Chapter 4.5 --- Investigator Folder Development --- p.32Chapter 4.6 --- GCP Documentation Collection and Development --- p.33Chapter 4.6.1 --- Curriculum Vitae Collection --- p.33Chapter 4.6.2 --- Site Personnel Log --- p.34Chapter 4.6.3 --- Subject Screening Log --- p.34Chapter 4.6.4 --- Subject Identification Code List --- p.35Chapter 4.6.5 --- Subject Enrolment Log --- p.35Chapter 4.7 --- Medication --- p.36Chapter 4.7.1 --- Capsules --- p.36Chapter 4.7.2 --- Randomisation Code --- p.39Chapter 4.7.3 --- Labelling of Study Medication --- p.40Chapter 4.7.4 --- Storage --- p.40Chapter 4.7.5 --- Drug Accountability --- p.40Chapter 4.8 --- Investigator Brochure --- p.41Chapter 4.9 --- Monitoring --- p.41Chapter 5. --- Method - Western medication clinical trial --- p.42Chapter 5.1 --- Protocol Development --- p.42Chapter 5.2 --- Consent Form Development --- p.43Chapter 5.3 --- Ethics Committee Submission and Approval --- p.43Chapter 5.4 --- Case Report Form Development --- p.43Chapter 5.5 --- Investigator Folder Development --- p.44Chapter 5.6 --- GCP Documentation Collection and Development --- p.44Chapter 5.6.1 --- Curriculum Vitae Collection --- p.44Chapter 5.6.2 --- Site Personnel Log --- p.45Chapter 5.6.3 --- Subject Screening Log --- p.45Chapter 5.6.4 --- Subject Identification Code List --- p.45Chapter 5.6.5 --- Subject Enrolment Log --- p.45Chapter 5.7 --- Medication --- p.46Chapter 5.7.1 --- Tablets --- p.46Chapter 5.7.2 --- Randomisation Code --- p.46Chapter 5.7.3 --- Labelling of Study Medication --- p.47Chapter 5.7.4 --- Storage --- p.47Chapter 5.7.5 --- Drug Accountability --- p.48Chapter 5.8 --- Investigator Brochure --- p.48Chapter 5.9 --- Monitoring --- p.48Chapter 6. --- Results & Discussion --- p.49Chapter 6.1 --- Protocol Development --- p.49Chapter 6.2 --- Consent Form Development --- p.59Chapter 6.3 --- Case Report Form Development --- p.65Chapter 6.4 --- Ethics Committee --- p.67Chapter 6.5 --- Investigator Folder Development --- p.68Chapter 6.6 --- GCP Documentation --- p.68Chapter 6.7 --- Medication --- p.69Chapter 6.7.1 --- Study Medication --- p.69Chapter 6.7.2 --- Randomisation Code and Code Break Envelops --- p.71Chapter 6.7.3 --- Labelling --- p.71Chapter 6.7.4 --- Storage --- p.73Chapter 6.8 --- Investigator Brochure (IB) --- p.73Chapter 6.9 --- Monitoring Visits --- p.75Chapter 6.9.1 --- Source document verification --- p.76Chapter 6.10 --- Results of Literature Search --- p.80Chapter 7. --- Discussion --- p.95Chapter 7.1 --- Discussion on the implementation of GCP in the two clinical trials evaluated --- p.95Chapter 7.2 --- Role and Importance of the Study Monitor & Results of Source Document Verification --- p.99Chapter 7.3 --- Blinding & randomisation procedures --- p.103Chapter 7.4 --- Good clinical Practice & TCM clinical trials --- p.103Chapter 7.5 --- Performing Literature Search in Preparation for TCM Clinical Trials --- p.110Chapter 7.6 --- Standardisation of Herbs and GMP Issues --- p.112Chapter 7.7 --- TCM Medical Practitioner (Investigator) Selection --- p.116Chapter 7.8 --- Method of Diagnosis --- p.117Chapter 7.9 --- Randomisation & Blind Assessment (placebo or control treatment) --- p.118Chapter 7.10 --- Adverse Events in TCM Clinical Trials --- p.122Chapter 7.11 --- Other Issues or Considerations & Future Work to be Performed at the CPSU --- p.122Chapter 8. --- Conclusion --- p.125Chapter 9. --- Reference List --- p.127Chapter 10. --- Appendices --- p.14