All institutions, personnel, instruments and equipment involved in clinical trials need to have corresponding qualifications. The qualifications of participants in clinical trials are as follows:

1, researcher

① Resume

② Registration Certificate of Medical Practitioner

③GCP certificate

④ Training record (as required: qualification certificate of medical practitioner)

2. Research nurses

① Resume

② Registration certificate of intern nurse.

③GCP certificate

④ Training record (as required: qualification certificate of trainee nurse/nurse/nurse in charge)

3. Drug administrators

① Resume

② Licensed pharmacist registration certificate

③GCP certificate

④ Training records

4. Committee on the Rights of the Child /CRA

① Resume

②GCP certificate

(3) the company's letter of appointment

④ Training record (as required: copy of diploma/degree certificate/ID card)

Preparation and necessary conditions before clinical trials

Clinical trial drugs are prepared and provided by the organizer. Before conducting clinical trials, the sponsor must provide preclinical research data of the experimental drugs, including prescription composition, manufacturing process and quality inspection results.

The pre-clinical data provided must meet the requirements of clinical trials at corresponding stages, and at the same time, the validity and safety data related to completed and ongoing clinical trials in other regions should be provided. The preparation of clinical trial drugs shall conform to good manufacturing practice.

The facilities and conditions of clinical trial institutions should meet the needs of safe and effective clinical trials. All researchers should have professional knowledge, qualifications and ability to undertake this clinical trial and receive training. Before the start of the clinical trial, the researcher and the sponsor should reach a written agreement on the trial scheme, monitoring, inspection and standard operating procedures of the trial, and the division of responsibilities in the trial.