Data Processing in Electronic Form
When processing data using electronic IRCs (individual registration cards), data entry is carried out directly at research sites. Further verification allows us to identify and correct errors at an early stage, as well as directly verify key documents. This method helps us to avoid the additional costs associated with double data entry from paper forms onto electronic databases, as well as significantly reducing the time for data processing.
Paper-based Data Processing
For small studies and at the discretion of the Sponsor, a paper-based data processing method is sometimes used. All steps to enter data into the database are performed in compliance with all applicable rules and procedures.
The data is processed using advanced clinical solutions based on various validated EDCs, including our own:
- Electronic data collection in accordance with the requirements
of 21 CFR Part 11; - Fully-validated software;
- Built-in patient randomization system;
- A module for planning and accounting of drug supplies;
- Data quality control using automatic and manual checks;
- Encoding of terms using the MedDRA and WHODrug Global dictionary;
- Import of data from external sources;
- Uploading of standard individual reports (customized if required);
- Compliance with CDISC requirements.
