Clinical Protocols


The clinical trial protocols shall include the following:
(1) Title of the clinical trials.
(2) Purpose, background and content of the clinical trials.
(3) Clinical evaluation standard.
(4) Analysis of risks and benefits of clinical trials.
(5) Name, title, post and the corresponding department of the clinical personnel.
(6) Overall scheme, including success or failure feasibility analysis.
(7) Time duration of clinical trials and reasons.
(8) Number of testing cases of each disease category and reasons.
(9) Scope of selecting subjects, quantity of subjects and reasons for the selection, and setup control group when necessary.
(10) Specific indication or scope of application for those curative products.
(11) Evaluation method of clinical performance and statistical processing method.
(12) Expected adverse effects and the necessary measures to be taken.
(13) Notice of Informed Consent for test subjects
(14) Descriptions of duties of the parties.