Verified Clinical Trials, Integreview IRB create new expedited research subject authorization review process
Verified Clinical Trials (VCT) and Integreview IRB have developed a preferred partnership to stop dual enrollment in clinical trials and reduce protocol deviations while promoting safety. Research sites, CROs and pharmaceutical sponsors will benefit from this alliance in an effort to stop dual enrollment in clinical trials and reduce significant protocol violations from occurring.
VCT is a North American research subject clinical trials database registry that not only prevents dual enrollment in clinical trials by research subjects, but also helps avoid other significant protocol deviations in clinical research trials. Integreview IRB is an ethical review board/independent institutional review board that's dedicated to providing unsurpassed ethical review services for research conducted in the U.S., Canada and Latin America.
VCT and Integreview IRB have created a new workflow to improve and accelerate use of the VCT authorization form. Ultimately, the process is designed to promote research subject safety and improve data quality. The new process employs VCT’s research subject database at the research site level. The two companies have developed a research subject authorization form to be utilized by research site staff when utilizing VCT’s services.
VCT allows the research site staff to check multiple inclusion or exclusion criteria such as concurrent enrollment, prior compound exposure, half-life violations or current screening at another site immediately following consent and authorization form execution. Integreview IRB offers a webpage on their company website for expedited review of the authorization form allowing easy access. This process results in both cost and time-savings.
"Integreview IRB and VCT are dedicated to promoting clinical trial safety and improved data quality," said Kerri Weingard, chief operating officer of VCT. "After consent, VCT is able to look into the research subject’s study history across the entire VCT database and provide answers to the site staff on those previously unknown details surrounding a research subject’s prior study history and eligibility based on the intended protocol’s criteria. Prior to VCT, site staff were not able to truly accomplish this."
Mitchell Efros, M.D., FACS and CEO, said, "VCT now is the sole system used in the great majority of early phase units in North America, as well as late phase site to prevent duplicate enrollment in clinical trials. We have created an even smoother process for our research site users. We congratulate Integreview IRB for understanding the need for an ID-metric HIPAA compliant research subject database. Integreview IRB has taken action and helped enable a simplified expedited process to a much needed solution.”