Provisions for Disclosure of Clinical Trial Programs

1. The clinical trial was conducted in an open manner to recruit subjects to participate.

2. Content of recruitment materials: recruitment materials shall be reviewed and approved by the Ethics Committee. Recruitment materials generally include the name and address of the trial organization, the purpose of the trial and/or trial-related information, a brief description of the inclusion and exclusion criteria, a brief description of the possible benefits and risks of participating in the trial, the time occupied by the subjects and other matters, the contact person or office and contact information for more information.

3. Publish recruitment advertisements: Publish recruitment advertisements in the form of posters, flyers, online platforms, WeChat and so on.

Requirements for the signing of informed consent by subjects in clinical trials

1. The researcher shall use the latest version of the informed consent form and other information provided to the subjects as agreed by the ethics committee.

2、Informed consent conforms to the principles of complete notification, full understanding, and independent choice, and the investigator shall explain the following details related to the trial to the subjects in the informed consent room. Including an overview of the clinical trial; the purpose of the trial; the trial treatment and the possibility of random assignment to groups; the steps of the trial that subjects need to comply with; the risks or inconvenience that the trial may cause to the subject; the expected benefits of the trial, as well as the likelihood of not being able to benefit; other optional drugs and treatments, and their important potential benefits and risks; the subject to obtain compensation for the occurrence of trial-related damage, as well as treatment; The possible compensation for the subject's participation in the clinical trial; the expected expenses for the subject's participation in the clinical trial, etc.

3, informed consent and other oral and written information provided to the subject should be used in plain language and expression, so that the subject or his or her guardian, witnesses are easy to understand.

4, when the subjects or their guardians fully understand the details related to the clinical trial, voluntary participation in the clinical trial. The subject or his/her guardian and the researcher executing the informed consent shall sign and date the informed consent form respectively, and if not signed by the subject himself/herself, the relationship shall be indicated.

Provision for not charging a portion of the costs associated with a clinical trial

According to the requirements of the Code of Practice for the Quality Management of Pharmaceutical Clinical Trials (2020 Edition), sponsors should provide trial medicines to subjects free of charge and pay for the costs of medical tests related to clinical trials.