Principle and manipulation of clinical trials(6)——Guidelines for standard operating procedure (continued 1)
XUE He-sheng
Cao Cai
TANG Dan-lin
Abstract：Part 5～8 of Guidelines for standard operating procedures produced by the Statisticians in the Pharmaceutical Industry (PSI) are introduced. Thoughtful procedures for designing, distributing and breaking randomized code lists are emphasized as well as supervising the actualization of the randomization procedure worked out. There should be detailed data management plan indicating the procedure of and the one responsible for the design and maintenance of the database. Interim analysis must be aforethought and consideration should be given to avoid its possible biased impact on the running trial. The writing and contents of statistical reports are also discussed.
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Publication Date：2001-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 262-266 )