According to the final rule on “Clinical Trials Registration and Results Information Submission”, clinical trial protocols and statistical analysis plans have to be published on ClinicalTrials.gov. The requirement affects all applicable clinical trials with a primary completion date on or after January 18, 2017. Personally identifiable information, as well as any trade secret and/or confidential commercial information can be redacted, before documents are made public. This article reviews the limited available guidance on how to prepare the documents for publication and the key questions to be addressed.
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