1. Keep your design simple. More then 100 parameters per subject is too much.
2. Plan your time. Start 6 months before first patient in. Plan to do a little bit every day.
3. Use eSource. Type the data directly into the EDC or into a tablet that inserts to the EDC
4. Ban SDV. Your primary endpoint, IE and adverse events should not be on paper anyhow.
5. Automate patient compliance measures. There are only 3: 1) Patient reporting compliance as measured by number of actual reports / number of expected reports. 2) Patient treatment compliance as measured by number of pills/treatment performed / number of treatment days 3) Number of compliance violations as measured by counting a clinical measure such as rescue medications.
