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9. Primary goal criteria

Please list the main variables relevant to your objectives/indication that are to be investigated.

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11. Influencing variables

If applicable, please list all factors that might affect your goal criteria, e.g., gender, height, etc.

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12. Type of study

Therapeutic studies examine which therapy is appropriate for a specific medical condition, and diagnostic studies examine the proper diagnostic strategy for a specific condition. Prognostic studies focus on the factors that influence the course of a disease for a patient, while epidemiological studies investigate the overall factors for a specific disease. Studies involving non-human observation units are pre-clinical studies. A meta-analysis is a statistical analysis comprising several studies.

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13. Information about the study design

Please indicate which criteria are applicable to your study. In a prospective study, the data that are to be analyzed were collected according to the objectives or the study protocol. Retrospective studies, on the other hand, analyze data that was collected without prior planning, i.e., before a study protocol was created. Controlled studies examine and compare two groups that are treated with the same intervention, where the control group is either a secure (e.g., an established therapy) or a neutral (e.g., placebo) variable.

In randomized studies, the study participants are assigned randomly to one of the groups. In addition, the handling of the group assignment of the patients can be either open, i.e., both the physician and the patient know which group the patient belongs to, single-blind, i.e., only the physician is informed, or double-blind, i.e., neither the patient nor the physician know which group a patient has been assigned to. Monocentric studies are conducted within a single institution, e.g. in a department.

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15. Is the total sample size known?

The total sample size is the number of cases, i.e., the sample size ideally suited for the investigation of your objectives/indication.

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16. Has a study protocol been completed?

The study protocol describes the planning and complete course of the study in detail.

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17. Liegt ein Formular für die Datenerhebung vor?

A data collection form is usually a standardized questionnaire or a CRF (case report form) designed to collect data.

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