Abstract: Documentation provides the basis for training study personnel and evaluating performance of personnel and study sites. It also serves as a reference for writing up reports and manuscripts for publication. Documentation also clarifies personnel and unit roles; this enables the principal investigator to make sure that all tasks are assigned and know which individual or unit is responsible if there is a problem. Further, documentation can codify usual procedures for such contentious issues as authorship on papers; by clarifying these up front, many problems can be avoided. Documentation for a study is generally consolidated in a single study manual. The study manual should include all forms used in data collection, codebooks, and descriptions of data flow, certifications, and quality control and quality assurance procedures. Studies tend to develop their own shorthand for referring to procedures or specific variables. The study manual should also include a section to note any deviations to the protocol and how they were handled. If the protocol is changed, the study manual should note the date of the change, and the new protocol should be added.
Publication Year: 2012
Publication Date: 2012-01-01
Language: en
Type: book-chapter
Indexed In: ['crossref']
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