Characteristics of a Good Case Report

Good case reports include the following elements:

1. Description of the adverse events or disease experience, including time to onset of signs or symptoms;
2. Suspected and concomitant product therapy details (i.e., dose, lot number, schedule, dates, duration), including over-the-counter medications, dietary supplements, and recently discontinued medications;
3. Patient characteristics, including demographic information (e.g., age, race, sex), baseline medical condition prior to product therapy, co-morbid conditions, use of concomitant medications, relevant family history of disease, and presence of other risk factors;
4. Documentation of the diagnosis of the events, including methods used to make the diagnosis;
5. Clinical course of the event and patient outcomes (e.g., hospitalization or death);
6. Relevant therapeutic measures and laboratory data at baseline, during therapy, and subsequent to therapy, including blood levels, as appropriate;
7. Information about response to dechallenge and rechallenge; and
8. Any other relevant information (e.g., other details relating to the event or information on benefits received by the patient, if important to the assessment of the event).