For applying for a clinical trial approval, an application form and the following documents are needed to submit:
1.Protocol;
2.Informed Consent From;
3.Advertisement on subject recruitment or any other documents regarding the recruitment procedures;
4.All written information to be provided to subjects;
5.Investigator’s Brochure;
6.Currently available safety data on the investigational product(s);
7.Descriptions of the payments and compensations to trials subjects;
8.The investigator’s current curriculum vitae or any other documents supported his/her qualifications;
9.Other essential documents specified by the Ethics Committee.

The Ethics Committee shall review a proposed clinical trial within one month and make a decision for one of the four review results:
1.Approval;
2.Reassessment after modification;
3.Disapproval;
4.Termination or suspension of any prior approval trials.

The review decision should be made in writing and include the following contents:
1.The title of the trial;
2.The institution and the investigator;
3.The reviewed documents and the version numbers;
4.The review results and reasons;
5.Year, Month and date.

The Ethics Committee should review the qualifications, curriculum vitae and any other relevant documentation of the investigator.

The Ethics Committee should depend on the degree of risk to human subjects, conduct continuing review of each ongoing trial at appropriate interval.
The preceding continuing review shall be conducted at least once a year.

A clinical trial is to be carried out with the consent of the subject’s legally acceptable representative, the Ethics Committee should ensure that the proposed protocol and other document(s) adequately addresses relevant ethical concerns.