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You can download CogState ClinicalTrials testing software from a secure server via a secure website. Only people authorized by you will receive the login credentials.

Sending data to CogState

The computer used for testing stores test results locally as encrypted data files. They are sent to CogState securely over the internet and the CogState server uses a site-specific key to decrypt the data once it is received. Each decryption key authenticates the source of data submission, and will not work on data submitted from a different study site, or from an unknown source. Test scores are computed using validated automated processes. Data is stored on the CogState server, backed up and ultimately archived.

If you are not connected to the internet, it is possible to send your data to CogState on a USB memory stick. Approximately 4,000 tests fit on a 256MB USB stick.

Viewing your data in real time

CogState provides you with access to DataPoint® - a secure, web-based data-viewing tool, which allows you to review data instantly online. This could be minutes after test completion if sites submit test data immediately. This online tool allows you to monitor subjects who have completed or partially completed testing and those who have missed test sessions. You can also view the date and time of each test, and confirm how often sites are submitting data.

If you give permission, sites can use the same web tool to review test information. While study sponsors can view data from all sites, sites only have access to data sent in from their own site.

Receiving data extracts

Data extracts are delivered via a secure-website or ftp transfer at the time points you specify (e.g., for dose escalation meetings, interim analyses). The final, fully quality-controlled dataset is available within 3 working days of receipt of the final CogState data discrepancy resolution.

Security

• A software activation code provides authentication of the site-to-CogState transfer link, preventing unauthorized users from submitting data to your study-specific CogState database. This code is entered when the software is installed.
• Data is transmitted in encrypted form.
• Data enters the study-specific CogState database.
• Ongoing backups are made.
• A disaster recovery plan is in place.
• Data is archived in a secure manner, in accordance with ICH GCP.

Compliance

All CogState systems are compliant with ISO 9001:2000, ICH GCP and 21 CFR part 11. In achieving this compliance CogState ensures:

• Limited, controlled access to software and in-house systems.
• Ongoing validation of computer systems.
• A fully auditable trail of data movements and analyses.