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What you need to know about Computer System Validation

More and more sites in Alberta are moving toward digital data management. Digital data allows sites to capture and manage information more efficiently and effectively. With this improved ability to collect data, we have a responsibility to ensure that information is accurate and valid. In situations where patient information is being collected, a Computer System Validation (CSV) must be performed to ensure that the system in which the information is being collected is operating as intended.  A CSV  provides validation and documentation that this is indeed the case. The ACRC has developed templates and samples in a CSV package for your reference.

Please visit the Alberta Clinical Research Roadmap's Toolbox to access the newly release Computer System Validation Package.

 

Attend the 2019 Alberta Clinical Health Research Conference

This conference brings together Alberta’s Clinical Health Research community for a day of discovery. With a focus on Alberta, this event highlights new and emerging areas in clinical health research, provides practical knowledge on conducting research in the province, and offers the opportunity to network and connect with others involved in clinical health research.

The day will include a mix of main and breakout sessions, provincial initiative updates, as well as booths where organizations will share their initiatives. A detailed program has been posted on the conference webpage.

Where: Best Western Plus Village Park Inn, Calgary, Alberta
When: September 20, 2019, from 8:00 am to 4:30 pm

Registration Closes September 9, 2019.

For more information or to register, visit the Conference webpage.
 

Health Canada Guidance Document Released

The Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100) - Summary has been released by Health Canada. Please visit the Health Canada website for more information.

This edition's hot topic glossary term


VALIDATION OF COMPUTERIZED SYSTEMS

A process of establishing and documenting that the specified requirements of a computerized system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The approach to validation should be based on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human participant protection and reliability of trial results. (ICH E6[R2])


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