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Community-Based Clinical Trials: Innovative Regulatory Procedures to Enhance Translation.

Presented at the Society for Clinical Trials annual meeting, Boston, MA, May 19-23, 2013.

Carmen L. Rosa, MS (National Institute on Drug Abuse), Royce Sampson, MSN, RN (Medical University of South Carolina, SC Node), Kimberly M. Pressley, MA (Lexington/Richland Alcohol and Drug Abuse Council, SC Node).

Currently there are more and more clinical trials conducted where clinical practice takes place -- a community-based medical clinic. However, most of the "real life" clinics are not usually involved in research activities and for them, most of the research-oriented procedures (especially the regulatory procedures and paperwork) could be burdensome. Health care providers are very busy in their day to day work and have little time to become familiar with all the research procedures before starting recruitment in a multi-site clinical trial. Based on their experience in conducting multi-site clinical trials involving community treatment programs, the speakers in this session addressed critical regulatory issues and provided some examples on how to manage and reduce the burden from several perspectives: sponsor, investigator, IRB reviewer and provider. The presentation ended with a look from the provider perspective, summarizing the issues and recommendations discussed and answering the question, "Why become a community treatment program research site?" (Presentation, PDF, English, 2013)

Keywords: Community health services | Research participation | Society for Clinical Trials annual meeting, 2013

Document No: 1007

Submitted by Carmen Rosa, MS (NIDA), 6/25/2013.


Pressley, Kimberly M. search mail
Rosa, Carmen L. search mail
Sampson, Royce search mail
Southern Consortium search www

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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
The materials on this site have neither been created nor reviewed by NIDA.
Updated 6/2013 --
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