Step | Definition | Example | Benefit |
---|---|---|---|
Identification | All possible study participants are recognized | Clinical trial alert (CTA) automated recognition running in the background of the practice computer software to filter out all women ≥60 and men ≥70 | No patients are missed Net sample automatically documented No effort required for the practice staff |
Eligibility check | Specifically defined inclusion and exclusion criteria are applied to the net sample | Practice staff (nurse or doctor) reviews patient data for exclusion criteria and checks appropriate box on screen | Practice staff can document exclusion criteria on the practice computer by making one click |
Contact | Eligible participants are informed about the study and are asked to participate | Practice staff introduces the study and asks for patient consent Patient response is documented using practice computer | Practice staff can easily document all patient contacts using the practice computer Study centre can monitor activity |
Enrolment | Patients follow through on their intention to participate in the study | Baseline osteoporosis survey is filled in using the practice computer Pseudonymised data set is immediately transferred to the study centre | No patients lost between the GP practice and study centre All survey data is immediately available |