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April 15, 2003

The Biomedical Research and Assurance Information Network, or BRAIN, is software designed to handle regulatory compliance mandates. Here are some of its most valuable benefits.

Focus on the science of a protocol rather than boilerplate text. BRAIN auto-matically includes the correct regulatory language on forms, based on specific data entered during protocol creation.

Automatic generation of consent forms. One BCM investigator insists that BRAIN makes it impossible to include the wrong consent form with a protocol — even expired forms are clearly labeled "not valid."

Less stressful audits. All official documentation associated with a protocol is stored centrally, rather than dispersed in paper form among different investigator offices and the Office of Research.

Faster, more responsive compliance programs. Amendments occur in two weeks (reduced from two to three months). An IRB's suggested modifications to a protocol are sent to investigators within 48 hours (reduced from one week). Board meeting minutes are compiled the same day (reduced from four days).

Greater efficiency. Principal investigators don't hound colleagues for signatures; BRAIN warns signatories when a protocol action is holding for their response. Analysts don't shuffle paper but instead review protocols against current regulations. And users can access BRAIN any time to check submission status or review a protocol.

Back to Rising to the Regulatory Challenge 


For reprints and/or copyright permission, please contact  Terry Manning, 781.972.1349 , tmanning@healthtech.com.