What does CRF Medical
Case report form
Synonyms: test sheet, CRF
The Case report form, short CRF, is a questionnaire for clinical studies or NIS in which the visit data for a patient are documented by the doctor according to the study plan or observation plan.
As a rule, the documentation takes place in pseudonymized form. The sponsor of the study will provide the questionnaire on paper or as online documentation. In terms of content, CRFs differ greatly from one another - depending on the issues. In addition to basic and anamnesis data on the patient, accompanying medications and adverse events are often recorded during the study. The integration of standardized patient questionnaires (e.g. on quality of life) is also possible. The sponsor must ensure that the CRFs (on paper or digital) are kept for at least 10 years after the end of the study.
If the patient data is recorded in electronic form, one speaks of a so-called eCRF, or Electronic Data Capture (EDC). Compared to the paper version, electronic data acquisition enables time and cost savings, as well as compliance with quality standards through automatic checks for completeness and plausibility. Further advantages of eCRFs are the user guidance when collecting the data and the possibility of detailed, real-time query management.
For electronic data collection, a program is installed on the doctor's computer through which the collected data is entered. After graduation, the data is not digitized - it only needs to be transmitted to the client of the study.
Technically, certain requirements of the FDA (Title 21 CFR Part 11) and GAMP must be met for studies that are relevant for approval.
3.2 Online CRF
Online CRFs are a variant of the eCRF in which the data is not stored locally on the doctor's computer, but rather web-based on a study server. The doctor logs on to the study’s own website and can thus create patients from anywhere and document the associated data. The most important advantage over simple eCRFs is that the data is available to the study sponsor in real time. All entered data can be permanently viewed and evaluated via a study center.
4 requirements according to GCP
- The entries must be correct, complete, legible and always up-to-date.
- The data documented in the CRF must match the original data (e.g. patient file, laboratory report, records from measuring devices). Deviations must be explained.
- Subsequent corrections in the CRF must be dated and signed. All changes must always be traceable in both the paper CRF and the eCRF. If the change results in new facts, this must be explained.
- Only those persons who have been authorized by the examiner or the main examiner of a test center may make entries in the test sheets.
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