Good Case Report Forms (CRFs) are crucial in conducting a successful clinical trial. CRFs capture data that will be used to evaluate the research questions asked in the protocol and to collect adverse event data for safety reports and processes.
Good CRFs should:
- Gather complete and accurate data that answer study questions (e.g. by avoiding duplication of data, easing transcription of data onto the CRF, and complying with the study protocol);
- Promote accurate data entry (e.g. by giving visual cues to the person recording the data, such as boxes that clearly indicate where data should be recorded, clear guidance about skip patterns and a clean, uncrowded layout);
- Organize data in a format that facilitates data analysis (e.g. by grouping on the same form data that will be analyzed together, where possible).
The ICSSC team can assist you with case report form development in the following ways:
- Comparison of your CRFs to your protocol
- Formatting of your CRFs to ensure accurate data collection and transcription
- Review of your Adverse Event CRF to ensure that you are collecting data needed for required safety reports
- Suggesting consistency and logic checks to be performed during data entry and subsequent data cleaning
- Mapping the links between CRFs to ensure that data from multiple forms can be linked for cross-form analyses
- Recommend header and footer information to properly identify each CRF
View presentations from past ICSSC events for information on CRF development.