Establishing Multi-site Study Procedures


CTNBP: Standard Operating Procedure (SOP) Resources

CTN Best Practices offers guidelines for writers, templates and a list of suggested SOPs for those conducting clinical trials.   

From Clinical Trials Networks Best Practices (CTNBP) of Duke Clinical Research Institute (DCRI).  https://www.ctnbestpractices.org/sites/sops

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NIA Clinical Research Study Investigator's Toolbox

NIA's Clinical Research Toolbox provides a study protocol template and manual of procedures for download and adaptation by study investigators. The study protocol template outlines a clinical trial protocol and provides guidance on important content to include in each section. The Manual of procedures facilitates consistency in protocol implementation and data collection across study participants and sites. The NIA Toolbox contains numerous other templates, sample forms, guidelines, regulations and information materials to assist investigators in the development and conduct of high quality clinical research studies.  

From the National Institute on Aging (NIA) Clinical Research Study Investigator's Toolbox.  http://www.nia.nih.gov/ResearchInformation/CTtoolbox

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Communications Practices of Columbia University's CTN Network

Columbia University's Clinical Trials Network offers this 'lessons-learned' summary of communications tips and best practices for others working in the context of Clinical and Translational Science Awards (CTSAs) and Practice-based Research Network (PBRN)s.  Click here to download.

Courtesy of J. Thomas Bigger, MD. Professor of Medicine and of Pharmacology and Medical Director, Columbia University Clinical Trials Network.  http://irvinginstitute.columbia.edu/resources/community_engage.html

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CTNBP: Study Startup Tools & Resources

CTN Best Practices offers several tools for the start up phase of clinical trials - including a pre-study checklist, new study checklist, site start up checklist, and tips for sites to consider   

From Clinical Trials Networks Best Practices (CTNBP) of Duke Clinical Research Institute (DCRI).  https://www.ctnbestpractices.org/sites/studystartup

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CTNBP: Screening, Enrollment and Start-up Tips

CTN Best Practices offers several tools for the start up phase of clinical trials - including a pre-study checklist, new study checklist, site start up checklist, and tips for sites to consider   

From Clinical Trials Networks Best Practices (CTNBP) of Duke Clinical Research Institute (DCRI).  https://www.ctnbestpractices.org/sites/enrollment

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AAFP-NRN Standard Operating Procedure (SOP) for Processing Data

This example of an SOP from the Academy of Family Physicians National Research Network (AAFP NRN) provides an example of the level of granularity that may be found in practice-based research networks and similar settings.  Click here to download.

Courtesy of Wilson Pace, MD and the American Academy of Family Physicians (AAFP) National Research Network (NRN).  http://www.aafp.org/online/en/home/clinical/research/natnet.html

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