Reports

Study Metrics

Real-time study metrics on the web site track key aspects of study operation. Principal reports document projected and actual study enrolment, specific enrolment by site or region, enrolment by study group or treatment, numbers of active and discontinued patients, site performance, data completion, and number of data queries. Other reports may be included at the sponsor's request.

Data Status Reports

More complex Data Status Reports are generated in real-time in pdf format. Key reports include:

> Data Review – This report allows viewing of the data from all CRFs that have been submitted to date in one report. These reports can be selected to include all data, or selected CRFs.

> Query Summary – A listing of the total number of queries generated, resolved and outstanding per site. If a query is outstanding, this report will describe the query.

> Form Tracking – A listing of the CRFs received to date, including the date of receipt.

Interactive Reports

Interactive reports are real time reports programmed to display data in a listing format which can be sorted, filtered, printed or exported at the user's preference. These reports can be programmed to include listings of the subject's dosing history, adverse events, demographics, co-morbid conditions and other medications. They can be easily customized and new reports can be generated upon request throughout the study as authorized by the study sponsor. These reports are created and customized to the data collected in the study.

Data Summaries

Data Summaries are static graphical or tabular reports of the cumulative data, normally created by a biostatistician for the purpose of sharing this information with the participating investigators. Examples include but are not limited to aggregate analysis of safety data (by MedDRA system class and/or preferred terms), economic analysis tables, Quality of Life scores, Disease Activity Summaries, Survival analysis etc. All sites normally have access to the data summary reports, and no individual patient data are available in this reporting format.

Finger-tip reporting
Syreon provides a variety of sophisticated on-line reports to monitor study progress and ensure compliance. Sites are able to access their own information through many of these reports, but cannot view data from other sites. The Syreon support team and designated medical monitors from the study Sponsor or monitors have access to the reports, as specified clearly in the Informed Consent Form.