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You may be asked to clarify items or make corrections to the Protocol and/or Results Sections of the record before the study record is posted.

For information about entering new data in a database, see the article Add one or more records to a database.

The process of submitting results information to Clinical is conceptually similar to preparing a manuscript for publication in a journal.

An individual familiar with the study design and data analysis (such as the clinical investigator or study statistician) will need to be involved in order to accurately summarize the results information in the tabular format required by law and to ensure that the results are consistent with the Clinical review criteria.

Scientific information is submitted as four separate modules: Participant Flow, Baseline Characteristics, Outcome Measures and Statistical Analyses, and Adverse Events.

The modules allow for the entry and display of information in a series of data tables with supporting notes but without narrative conclusions about the results.

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For more information, see: A Clinical staff member will review the study record after it is released (submitted) and before it is posted on Clinical

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