OBJECTIVES: It is well recognised that electronic data capture (EDC) is revolutionising the data collection and management of clinical trials data especially for pre-registration Phase I to III studies. We will discuss the benefits of the use of EDC for patient reported outcomes and especially within the context of large observational studies. METHODS: Using EDC, patient reported outcome data are collected directly by the patient onto the data capture device; this can be either a tablet pc at the study site or using a PDA for diary data. Whilst the patient is entering data, the device will prompt them if they do not fill in the questionnaire correctly or do not complete particular questions. RESULTS: Even this simple interaction with the patient of ensuring the answer provided is the most appropriate one improves the quality of the patient reported outcome data. For example, the query rate for these data is usually reduced from 6 to 10 fold compared with paper CRF collection and of course for patient reported data these queries usually cannot be updated so that these data remain inconsistent and of poorer quality. Other benefits include the on-line reporting of data which is especially beneficial for observational studies of moderate to long duration. Often several statistical reports are made from these data for example by conducting interims for baseline data, 3-month, 6-month, and 1-year data, etc. These reports were often produced several months after the last data were collected due to the delay between data processing of paper CRF data and the processes involve with statistical reporting. CONCLUSIONS: Now it is possible to provide near real-time access to reports via EDC working with a suite of pre-validated statistical programs. These can be produced on an on-going basis, for example we can update our reports daily.