Electronic Data Capture - TARDICE

Existing Paper Based System of Data Collection

Currently 90% of clinical trials use a manual recording process involving multiple layers of data transcription from document to document with inevitable cumulative sources of human error. Key images such as CT and MRI scans which are central to assessment of drug activity and safety are usually stored at a distance from patients’ notes. Central review of images involves copying and couriering to a single point. Key study documents are held in several locations throughout the course of the study and require repeated reviewing to maintain version control and accountability records. All data then undergoes continuous, exhaustive rounds of review and correction before data entry into databases, which is another manual process performed in duplicate. The lag period between data collection and data entry is often months hence the occurrence of drug related events and trends or patterns can remain unrecognised for long periods of time. Database lock is usually about one to two months after the end of the study.

Need for Change

Recent scandals and the withdrawal of drugs due to severe health risks missed during clinical trials is forcing pharmaceutical companies to re-evaluate the entire data management system. They are now under extreme pressure to reassure stakeholders, government agencies and the public of their ability to provide fast, accurate unequivocal evidence of the safety of their products. The demand for improvement and speed is now driving the industry towards electronic data capture systems which can be accessed quickly from a distance and have built in data checks to improve data quality.

TARDICE - Transfer, Archiving and Retrieval of Data and Images in the Clinical Environment

The TARDICE consists of a user-friendly hand held PDA or laptop unit with a pre-defined set of study questionnaires linked to an offsite data storage system offering safe transfer of confidential information and monitoring of data. As well as alphanumeric data, images such as CT or MRI scans, photos etc are captured on the TARDICE and transmitted to a secure database managed at a central location. Edit checks and prompts for missing or incorrect entries ensure capture of complete datasets and reduces error rate. As any form of document can be encrypted and held as an attachment on TARDICE the entire study regulatory documentation for a clinical trial can now be held and accessed in electronic format both at the doctor and the sponsor level. This will reduce the normal monitoring requirements for the study and permit a level of control previously unobtainable with the current paper system.