YY/T 0991-2015Clinical trial guideline for orthodontic brackets (English PDF)

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

1 Test Range

This standard specifies the orthodontic brackets clinical trial patient population, medical ethics and the interests of the subject during the test, observation and evaluation of clinical Test results of the evaluation assessment, clinical trial reports.

This standard applies to the clinical treatment of orthodontic brackets used in the product.

2 Clinical trials and hospital personnel requirements

2.1 Clinical trials should have qualified in medical institutions worked.

2.2 Clinical trials should have a project leader associate professional titles, the test should orthodontic specialist in clinical work for 5 years the above.

2.3 clinical trials is the use by staff of medical institutions from the project leader blinded panel of experts meets the above qualifications randomly selected.

2.4 Clinical trials should national GCP training (drug clinical trial guidelines) qualification.

2.5 multi-center clinical validation should be performed simultaneously by two or more different hospitals (including two), the hospital should be nationally recognized qualification.

3 Study population

4 Medical Ethics and a subject interests

Clinical trials required to obtain review by the ethics committee, and all participants should be informed consent and signed informed consent in clinical trials.

Participants are free to withdraw at any time in clinical trials. Subjects related information should be kept confidential.