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Concomitant medications (list names only): ..... Section Name/ Type of Toxicity ..... Submit all supporting documents (death certificate, autopsy report, etc.) 1.
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What is case report forms?
Case report forms are documents used in clinical research to collect data on individual study participants. These forms capture information about the participant's medical history, demographics, study interventions, and outcomes.
Who is required to file case report forms?
Researchers, clinical trial coordinators, and other personnel involved in conducting clinical studies are responsible for filing case report forms. It is their duty to accurately collect and document the required data for each study participant.
How to fill out case report forms?
Case report forms are typically filled out by directly entering the participant's data into an electronic system or by completing a physical paper form. The forms should be completed following the study protocol and any specific instructions provided by the study sponsor or regulatory authorities.
What is the purpose of case report forms?
The purpose of case report forms is to collect standardized and consistent data from study participants. These forms ensure that data is captured in a structured manner, allowing for accurate analysis and interpretation of the research findings.
What information must be reported on case report forms?
Case report forms typically require the reporting of participant's demographics, baseline characteristics, medical history, study interventions and outcomes, adverse events, concomitant medications, and any other relevant data specified by the study protocol.
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