It is important for our clinical trials to meet the international standards, such as the ICH/GCP guidelines. We provide a broad range of quality and cost-effective clinical trial services, committed to improve the standard of the clinical trials carried out in the Faculty and beyond. Mission: To upgrade the quality of clinical trials and enhance the awareness of ICH/GCP standards among clinical trial related professionals. Protocol Development Our staff are available to evaluate and assess new protocols and provide advises early in the planning of clinical trials. Our services and capabilities include: Protocol design and review Case Record Form design and review Randomization plan and implementation Sample size planning   Submission for Clinical Research Ethics Committee (CREC) Approval Careful preparation of the application documentation prior to submission to CREC is critical to ensure that the application is processed in a timely and efficient manner. We are familiar with local CREC operation and requirements and are available to assist investigators with their CREC applications. Our services and capabilities include: CREC application documents review and assessment Informed Consent Form development Recruitment Advertisement preparation Progress report writing   Data Management & Analysis for Clinical Trials Our data management experience covers various specialties including medicine, surgery, obstetrics & gynecology, pediatrics, ophthalmology, psychiatry, orthopedics & traumatology, geriatrics and oncology. Our staff have provided statistical consultation and contracted statistical services both locally and internationally. Our services and capabilities include: Database design and construction Date entry and verification Statistical design and consultation Customized reporting writing Review of study reports Statistical programming   Supporting Traditional Chinese Medicine (TCM) Clinical Trial Research We have been working with different Faculty members to support their TCM trials, including some of those which are part of the Area of Excellence Program, CUHK. We also serve as a member of the Executive Committee of the Institute of Chinese Medicine and a member of the Clinical Trial Section of the Institute. Liaison with Drug Companies We have maintained an excellent network with the major drug companies, and have been performing contracted services for these companies. At lease five of these companies have used our contracted services in the last twelve months. These also include some companies who are actively seeking collaborators in the Faculty; referrals have been made to Faculty's investigators for pursuing the chance of collaboration with these companies. Participation in Major Clinical Trials The Centre has been participating in some major international multi-centre trials, such as a study to examine the effects of various treatments carried out in patients with nasopharyngeal carcinoma. We have also been serving as members of Data Safety Monitoring Committee for some multi-centre trials.   Training on Clinical Trials In the last year, the Centre has provided training on clinical trials via its Post-graduate Diploma and MSc Programs, workshops in Biostatistics and Clinical Trials, as well as a two-day Workshop: "Planning and Conducting a Successful Clinical Trial: Good Clinical Practice (GCP)". Besides, it has presented a series of lunchtime seminars, on clinical trials in 2001 that are free to the audience. These include:   GCP in clinical trials Understanding of phase II trials Planning of clinical trials Trial monitoring and SAE reporting Informed consent in clinical trials Outcomes in clinical trials Meta-analysis of clinical trials Indemnity in clinical trials Ethical issues in genetic studies These workshops were very well attended by our Faculty members and outside researchers. Jointly with the Hospital Authority, we also hosted a symposium and a workshop on ethical issues related to carrying out clinical trials in February 2002. Such was the first comprehensive symposium on the topic. Another series of clinical trial seminars will be launched throughout 2002. For those who are interested in our training activities, please visit our website http://www.ccter.cuhk.edu.hk/workshop/. Faculty members may be charged for taking these courses and workshops.   Supporting the Clinical Research Ethics Committee (CREC) of the Faculty of Medicine, CUHK We have designed a Serious Adverse Event (SAE) Reporting System for the CREC of the Faculty. It has been implemented by the Centre around March 2002. A website has been launched and investigators of all clinical trials which have obtained ethics approval from the CREC will report SAE to the CREC in a timely manner. Investigators will also be reminded to renew their ethics approval after twelve months of the ethical approval of the trials via this system. A set of Standard Operating Procedure is available on our website. A workshop was also run in February 2002 to support researchers in using this new system. CCTER, on behalf of the CREC, CUHK provides supporting services and handle enquiries in the areas of: SAE reporting from study sites Maintaining a SAE reporting website Reminding of annual renewal of ethical approval Continual education activities