Hi Hanming-Our responses below! Thanks for the comment
Dawn and Dan

1. We know that studies in different therapeutic areas may collect completely different information and have different trial cycles. What can we do to balance the standardization on study setup and flexibility requirement for different studies?

In order to address the issue of standardization and study setup time, ( two key factors for many companies running clinical trials ) , Octagon has developed a "Base Study". This base study was designed to not only reduce the setup times for a clinical trial (while simultaneously reducing cost) but also to leverage SDTM standards. The current base study contains nineteen (19) standard eCRF modules for forms such as Demographics, Medical History, Physical Examination, Adverse Events and End of Study. As Octagon continues to build additional databases across different therapeutic areas, the standard eCRF library will continue to grow. Since our FUSE databases are built upon the principles of SDTM, the standard variable names and controlled terminology are determined prior to startup. These variable names are independent of therapeutic area so are able to be interchanged across different study setups. The only customization would be the study specific eCRFs and domains which are specific to the protocol and therapeutic area.

2. The very promising part of EDC systems is that we collect clean data in real time. But there are situations that users may not have clean data or complete information at the time of entering data. Should an EDC system allow 'dirty' data to be collected and to be resolved later? What are the cases such 'dirty' data should not be allowed?

EDC systems are set up to capture clinical trial data in real time, regardless if the data is clean or not upon entry. The power of EDC is that built into the system up front are edit checks (soft edit checks) which fire upon form exit to alert the study coordinators that there are issues which need verification/resolution in the data. These data updates can then either be made during data entry or after subject data has been entered. This allows the flexibility for the study coordinator to continue to enter data and address concerns at a later date which allows them to not have data "pile up" at a site. Because the CRA can view the data online, monitoring can occur more efficiently and effectively because the monitor knows the issues prior to arriving on site. They are also even able to query online prior to arriving at the site for clarification of any suspicious looking data.There may be some instances where critical data points are being collected and it may require the Study Coordinator to address those queries immediately. These are called "hard" edit checks and the number of hard edit checks are determined when specifications are gathered.