A Case Report Form or CRF is a questionnaire specifically used in clinical trial research. The CRF is the primary data collection tool from the investigator site. The trial sponsor is responsible for development of a CRF that accurately represents the protocol of the clinical trial, management of CRF production, monitoring of data collection, and auditing of the content. All data, information and results on each patient, participating in a clinical trial, are held and/or documented in the CRF.

eCRF, or electronic CRF, the traditional paper based collection of Case Report Forms is defined as a set of computer forms.

The format developed by CLINNOVO RESEARCH LAB is based on the operational data model (ODM) developed by the Clinical Data Interchange Standards Consortium, the body which sets industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data.

Online electronic data acquisition is extremely fast - and less error-prone . The automated transfer of data from measuring instruments and data acquisition systems greatly reduces the effort of data acquisition, and it helps avoid data entry errors. Quantitative and qualitative statements may be made at any point of the study - even as data acquisition is still in progress.

It is now possible to cut the time from entering the last patient data (Last Patient Out) to closing the database from an average of four months (!) in conventional paper-based research documentation - to as little as 48 hours.

This enormous time saving is made possible by concurrent processing of data acquisition, query management, and data consistency checks as well as centralized online data storage.

eCRF Features:

• Timely and rapid data acquisition and reporting
• Integrated data check for completeness
• Integrated query management
• Standardized documentation of adverse events
• Individually configurable roles and authorizations
• Monitoring optimized by integrated reporting
• Optimized tools for study control
• Automatic acquisition of measured data, using pulmonary function analyzers offered by our partners
• Data Capture
• Individual integration of existing SQL data from external databases during the evaluation stage
• Data output in any desired format
• Compliance with the requirements of the FDA (21 CRF Part 11 Electronic Records and Electronic Signatures)