Writing case report forms

Writing Case Report Forms

A case report form (CRF) is a paper or electronic document used in clinical research to collect data on individual participants in a study. CRFs typically include a set of questions or prompts designed to capture specific data points related to the study’s objectives. Here are some key steps to follow when writing case report forms:

1. Define the study objectives: The first step in writing a CRF is to define the study objectives. This will help you determine the data points that need to be collected and the questions that need to be included on the CRF.
2. Develop a data dictionary: A data dictionary is a table that defines each variable that will be collected on the CRF. The data dictionary should include the variable name, data type, format, allowable values, and any data validation rules.
3. Determine the data collection method: You need to determine the method of data collection, whether it will be paper-based or electronic. If it is paper-based, you will need to design a form that is easy to complete and understand. If it is electronic, you will need to design a user-friendly interface that is intuitive and easy to navigate.
4. Draft the CRF: Based on the study objectives and data dictionary, draft the CRF. The CRF should include questions that are clear, concise, and relevant to the study objectives. Use simple language and avoid technical jargon.
5. Pilot test the CRF: Before finalizing the CRF, pilot test it to ensure that it is easy to complete and that the data collected is accurate and relevant.
6. Review and revise the CRF: Review the CRF to ensure that it is complete, accurate, and relevant to the study objectives. Revise the CRF as needed based on feedback from study staff and participants.
7. Obtain approval: Obtain approval from the study sponsor, institutional review board, and other regulatory bodies before using the CRF in a study.

Overall, Writing case report forms requires careful planning, attention to detail, and a clear understanding of the study objectives. It is important to involve a multidisciplinary team in the development of the CRF to ensure that all aspects of the study are considered.

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