Study Protocol Option
Designed to enhance study execution and resulting data management, the Study option enables users to define a complete study prior to any data collection or analysis and easily summarize resulting data into reports through DSI Reporting. Operating on Microsoft SQL Server technology; the Study Option facilitates data management across multiple workstations, increases data security and reduces errors.
Increase confidence in your study outcomes:
- Minimizes errors.
- Run analysis across aggregate study data.
- Facilitates globalization, data sharing and backup with networking flexibility.
- Immediate access to current studies as well as archived studies.
- Consolidates derived parameters needed for reporting outcomes.
Study Option facilitates study preparation via an easy to use set-up wizard that guides the user through parameter definition:
- Number of animals
- Number of groups
- Number of days and
- Number of workgroups (Tox Studies)
- Acquisition periods: Cycle or time basis
Once the study template is completed, the user can initiate data acquisition by simply selecting the appropriate animal for data collection from a list box. To ease set up and execution of large studies or multi location acquisition, Setup information can be copied, archived and automatically copied across an internal network to other P3 workstations.
- Telemetry studies consisting of greater than 16 sources require more than one P3 Workstation.
- Tox based protocols could be more than one P3 Workstation to accommodate subject number or facility design.
The Ponemah program manages all data files collected throughout the study in an underlying SQL Desktop Database Engine. The SQL database provides structure and control, allowing users to run studies consistently across workstations locally or worldwide, making study a necessity in global organizations.
Structured Data Handling:
Advanced File Management:
- MSDE – Microsoft SQL Server Desktop Engine, provides a true database for structured data handling. The MSDE is loaded during Ponemah software installation and is transparent to the user. Running in the background, the MSDE works to develop data storage study tables automatically based on the user defined Study name.
Communication with other databases:
- Automatically handles derived/calculated values, Log information and event information from Study generated Acquisition, Replay and Review sessions.
- Alleviates difficulty in naming datasets as the Study Option automates this process through the Run Study dialog. Datasets are identified automatically in a logical manner.
- The data structure minimizes errors due to manual recollection methods over long studies. Users can select the dose day, test subject, etc… and review or replay the data by that selection. Study locates the needed files automatically!
- Once a Study has been defined, that structure of the study can be used to setup a future study eliminating the need to re-enter any study information with the exception of the study name.
- MSDE allows users to detach and reattach databases to different instances or to the same instance through P3.
- MSDE is fully Open Database Connectivity (ODBC) compliant using Structured Query Language (SQL).
- Since it is ODBC compliant, queries may be developed to mine the data or archive to other databases.
Security can be maximized by using the Study Protocol Option in conjunction with the Data Security Option. This option allows the system to be configured so that user interaction can be controlled through access levels within the software. The Data Security Option allows the system to operate in compliance with FDA 21 CFR Part 11 and allows data to be archived in a secure environment.
All data acquired with the Ponemah software platform from active and completed studies are available for customizable analysis, visualization, and reporting almost immediately after acquisition. DSI Reporting generates individual derived data listings, group mean summary tables (summary statistics) and graphs. This output is directly incorporated into MS Word. Tables and graphs can be locked so no changes can be made to the final report and a date and time footer designates when reports were generated.