A case report is a detailed description of an individual patient case. It focuses on documenting a unique or exceptional situation, such as a rare diagnosis, treatment, or follow-up. Case reports also include some demographic information about the patient (e.g., age, gender, ethnic origin).
The main goal of a case report is to share knowledge about such unusual cases, often with the aim of raising awareness among physicians and researchers of unknown or rare clinical phenomena. It is a descriptive report without systematic comparison or statistical analysis. Hypotheses are often not tested.
As many journals require an EC opinion for case reports, we recommend submitting them to EC Research.
A case report may be submitted directly to EC using the tool below, no submission to CTC is required. When data from UZ Leuven are transferred to another center in the context of a case report, a data transfer agreement is not always required. The transfer is covered by the approval letter of EC Research, which specifies the conditions for the transfer. The transfer can take place, on the conditions
1) that the data will be processed with appropriate care in accordance with the GDPR-principles,
2) that the necessary measures are in place to allow for a secure processing preserving strict confidentiality of the data,
3) that the data are only used for the specific purpose as submitted to EC Research, and
4) that the data must be deleted by the receiving party or, where applicable, returned to UZ Leuven, upon completion of the project.
If a study has a broader scope, and its primary aim is to analyze a condition within a specific context—often with a focus on generating hypotheses or investigating complex relationships—it should be registered in the registration form as a retrospective study (if only retrospective data are used), or as an experiment (if prospective data are also collected and the study qualifies as such).
ICF template for case report
In addition to the ICF (without the patient's name), please also provide us with a brief explanation (covering letter) of the case description. The ICF can only be signed by the patient after EC submission and approval. Make sure that you do not provide the name of a patient to EC.