Understanding the Role of IRBs in Clinical Research: A Quick Guide

Posted by Complion on Jan 16, 2017 8:11:37 AM

The ultimate goal of clinical research is to provide relief from, if not outright cures for, the various maladies and infirmities that plague human beings. In the ever-evolving world of research, history has shown that human frailties of another variety can sometimes send the pursuit of that goal down a less noble path. Effective regulation helps to ensure that that ultimate goal remains dominant among the many motivations that drive research.

Institutional review boards are an important example of regulatory efforts to insure the protection of the rights of human research subjects, as well as the protection of the patients who will ultimately benefit from the treatments resulting from that research.

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Topics: Clinical Research Ethics, Human Subject Protection, Compliance

A History of Clinical & Human Subject Research

Posted by Complion on Jan 4, 2017 4:11:17 PM
“Discovery consists of seeing what everybody has seen and thinking what nobody has thought.”
-- Albert Szent-Gyorgy (1893-1986), winner of the 1936 Nobel Prize for Physiology and Medicine

In light of the remarkable level of technological complexity and sophistication in today’s clinical research it can be too easy to lose sight of the fact that the roots of today’s research are long and deep, spanning centuries. Each breakthrough, each moment of discovery in that long history was, as Nobel laureate Albert Szent-Gyorgy describes, a moment in which someone looked at what others had already seen and saw something new.

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Topics: Clinical Research Ethics

Streamlining Delegation of Authority Documentation in Clinical Research

Posted by Complion on Nov 8, 2016 11:39:09 AM

Effective and efficient record-keeping and documentation is the life’s blood of clinical research -- its importance can’t be overstated. A key facet of that documentation is capturing and maintaining information regarding the Investigator’s delegation of responsibilities within a clinical trial. 

The US Food and Drug Administration provides guidelines addressing the delegation of those responsibilities. But how do you transform a set of FDA guidelines into  a concrete, effective, real-world strategy for documenting that delegation?

The latest Complion feature article offers an answer to that question.

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Recruitment & Retention in Pediatric Clinical Research Trials

Posted by Complion on Nov 4, 2016 10:58:37 AM

Without question, clinical research is essential to driving the improvement and evolution of healthcare. In achieving that goal,  “the most important thing is to help people currently in need and those who come after to lead healthier, happier lives, “ according to Janelle Allen, Project Manager and Research Coordinator in the Pain Research Center at Cincinnati Children’s Hospital Medical Center. Janelle is a Certified Clinical Research Professional with a long and distinguished track record.

Of course, the people who agree to participate as research subjects are absolutely critical to the success on any trial. For that reason, Janelle has focused her considerable experience and insight not just on meeting the daunting challenges of recruiting research subjects for pediatric clinical trials, but also on retaining those young subjects -- and their families -- throughout the duration of the trials in which they participate.

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Topics: Recruitment

Going Paperless: A Shared Journey

Posted by Complion on Nov 1, 2016 5:12:08 PM

While your organization may be working in the shadow of a growing mountain of paper documents and regulatory binders, the prospect of transitioning to an electronic document management system can be daunting. After all, you’ve been using your current system for a while. It may be a relic, but it’s a familiar relic. You know how it works, and you know what to expect -- even though you know that a better solution is available.

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Topics: eRegulatory, Paperless Clinical Trials