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Source: National Bureau Review CenterEditor: wangxinlai2004
On July 25, 2022, the Evaluation Center of the State Administration issued the "Guiding Principles for Blinding of Drug Clinical Trials (Draft for Comment)", and the time limit for soliciting comments is 1 month from the date of relea.
main content
This Guiding Principle is divided into eight parts, the main contents of which are as follows:
The first part is "Foreword", which first introduces blinding and related , and then leads to the purpose of drafting this guideli.
The second part is "Blind Classification", which introduces the blind classification of drug clinical trial.
The third part is "Blinding Measures and Operations", which introduces common blinding measures , including allocation concealment, treatment simulation, drug coding, blindness maintenance of research participants, blinded data review and independent evaluati.
The fourth part is "Unblinding Methods", which introduces common unblinding methods in clinical trials, including emergency unblinding, interim analysis unblinding, and post-study unblindi.
The fifth part is "Accidental Blind Break Handling", which introduces the definition and related operations of Accidental Blind Bre.
The sixth part introduces the relevant operations of blind monitoring for "blind monitorin.
The seventh section, "Other Considerations," introduces other , such as pre-training drills on blinding measures, and minimizing the number of people exposed to blindne.
original notice
In order to clarify the systemic and normative requirements for blinding implementation in drug clinical trials, our center has drafted the "Guidelines for Blinding of Drug Clinical Trials (Draft for Comment)", which is now publicized on the center's website to widely listen to opinions and suggestions from all walks of li.
We sincerely welcome valuable comments and suggestions from all walks of life on the draft, and timely feedback to us for subsequent improveme.
Please send your feedback to the following email addresses:
Contact: Zeng Xin
Contact: zengxin@c.
Thank you for your participation and great suppo.
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