Programming
Programming is often thought of as a large black box; quite maddening. Our goal is to reduce the madness in processing data so that it becomes simpler and easier to understand. The listings, tables and figures will be clearer, presenting the results in an appropriate and concise manner.
Database setup
- SAS based system based running under Windows XP
- Definition of the database takes your requirements into account
- Check of the database structure by a second programmer or data manager
- Use of test data to validate the system
- Any issues concerning the database are documented
- The system has been used for many studies varying in size from 20 to hundreds of patients, since 1995
Implementation of central data such as laboratory data,
central ECG readings etc
- Preparation of datasets according to agreed specifications
Data validation checks
- Queries are programmed according to the validation plan
- and are stored on the study database
Derivation of analysis datasets
- Conversion according to customer specific requests
Data listings, patient profiles, summary tables and figures for clinical study reports and publications
- Standard method of programming
- Standard validated macros are employed in the writing of programs
- Each program is validated by reprogramming, by checking the source code or checking the output
- QC is performed by an independent person
- Program issues are documented
- Program status is documented by the version number on the output