Challenges and questions remain as the one year anniversary of the implementation of the Revised Common Rule approaches

One year has passed since the implementation of the Revised Common Rule, and many challenges and questions remain. While IRBs wait for promised guidance to materialize, we are left to interpret various aspects of the rule ourselves. This has resulted in variability across IRBs in how the new requirements are interpreted and operationalized. Variability in […]

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Asentral IRB Joins BRANY IRB (Biomedical Research Alliance of New York)

For Immediate Release 17 December 2019 Asentral, Inc. Institutional Review Board (IRB), based near the biotech hubs of Boston and Cambridge, Massachusetts, is joining BRANY, company officials announced today. BRANY will provide its full suite of IRB services to Asentral’s current clients. “Asentral was founded by research professionals with deep research experience, and has been […]

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The Critical Issues Sites Need to Track During a Clinical Trial – Part Three – Enrollment

Congratulations! You have gone through all the necessary steps to launch a clinical trial. Now it’s time to move on to the next one, right? Wrong! A successfully managed clinical trial requires ongoing tracking throughout its duration. Careful tracking ensures your research organization remains compliant and that your site is compensated properly for the study. […]

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The Critical Issues You Need to Track During a Clinical Trial

Congratulations! You have gone through all the necessary steps to launch a clinical trial. Now it’s time to move on to the next one, right? Wrong! A successfully managed clinical trial requires ongoing tracking throughout its duration. Careful monitoring ensures your research institution remains compliant and that your site is compensated properly for the study. […]

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The Critical Issues Sites Need to Track During a Clinical Trial

Congratulations! You have gone through all the necessary steps to launch a clinical trial. Now it’s time to move on to the next one, right? Wrong! A successfully managed clinical trial requires ongoing tracking throughout its duration. Careful tracking ensures your research organization remains compliant and that your site is compensated properly for the study. […]

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News Release – BRANY Names Michael Belotto as Chairperson for Social-Behavioral IRB

NEWS RELEASE BRANY (brany.com) has announced that Michael Belotto, PhD, MPH, CCRC, CCRA, will serve as chairperson for their social-behavioral IRB. The SBER IRB is comprised of a multidisciplinary group of experts in social and behavioral research, as well as human subject protection. “Dr. Belotto has been a great contributor to BRANY IRB’s success over the past […]

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The Revised Common Rule and New “Concise Summary” Requirements

Our own Linda Reuter offers thoughts on how to meet new ‘concise summary’ requirements on informed consent for clinical trials. https://bit.ly/2JUQ8o3    

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New CITI Program Courses and Webinar Help Researchers and Institutions Meet Regulatory Requirements

(Miami, FL) — The Collaborative Institutional Training Initiative (CITI Program), a division of BRANY, has announced new online courses and webinars designed to help research professionals understand and comply with regulatory requirements for clinical trials. The three courses and webinars address critical regulatory requirements: Transitioning research to the Revised Common Rule Protocol registration and disclosure […]

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Is This the Right Study for Your Research Site? Five Questions You Should Ask Before Agreeing to be an Investigator

Clinical investigators often have multiple opportunities to participate in sponsored clinical trials. In addition to the professional satisfaction of being at the forefront of therapeutic development, clinical trials present an ability for physicians to offer patients alternatives to treatments they may otherwise be unable to access. While study sites may receive compensation for time and […]

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Four Essentials for Clinical Trial Enrollment

Clinical trial enrollment continues to be one of the most vexing challenges for research institutions and sponsors. Despite one quarter of sponsors’ clinical trial budgets being allocated to enrolling participants, half of research sites enroll only one or no patients in studies. Recruiting a diverse patient population is an even bigger challenge, with ethnic minorities, […]

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