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Max Planck Institute for psychiatryStaying mentally healthy during social distancing, quarantine and exit restrictions due to the corona virusBehavioural therapeutic interventions in a short programme
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A study protocol is a document that outlines the objectives, design, methodology, statistical considerations, and organization of a study. It serves as a plan for the research to ensure consistency and reliability.
Researchers, institutions, or sponsors conducting studies involving human subjects or specific types of research often must file a study protocol. This ensures compliance with regulatory standards.
To fill out a study protocol, one must include details like the study objectives, background information, participant criteria, methodology, data collection methods, analysis plan, and ethical considerations.
The purpose of a study protocol is to provide a detailed plan that minimizes biases, enhances transparency, ensures adherence to ethical standards, and aids in the reproducibility of the research.
Key information reported in a study protocol includes objectives, hypothesis, design details, participant eligibility criteria, data collection methods, statistical analysis plan, and details concerning ethical approval.
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