The immediate goal of any study is to gather data. Therefore, such is the data management plan prior to the study, and begin the treatment or during the study.
Human studies generate three types of data
- Patient's perspective (eg questionnaire on symptoms, well-being, life style, ...)
- Physician perspective (v. Physical Examination muscle tone, flexibility, ...)
- Objective (measured) data (lab results, weight, ...)
The data-mining is carried out systematically by
- CRF (Case report form): A staff member (physician, study nurse), the study-specific data
transfers per patient in a form. This can happen in paper form or electronically.
- Structured interviews: An investigator translated patient information into actionable medical
- Expression of laboratory data and medical examinations.
- Questionnaires can be contributed by study participants as a "self assessment".
- Entering the data per hand into a statistical program, we always recommend to make th
input twice. The subsequent statistical analysis of study results and consider any typos, because
identifying the differences between the two sets of data typo (double entry method).
The statistics produces:
- Plausibility check
- Descriptive Statistics
- Analytical Statistics
By this we mean graphic design, charts, tables, ... for presentations, publications, conference contributions.