Better Tools for Multi-site Research

This site is designed to guide potential investigators in organizing a clinical research application and to provide information on conducting a study and maintaining an award. Here you will find: an Overview of Human Subjects Research, pre-application Information, Peer Review Details, Funding Information, and more. This site addresses issues most commonly found in grant awards, and also includes glossary links to help to define terms related to NIH funding of clinical research.   

From the National Heart, Lung and Blood Institute (NHLBI) Clinical Research Guide.  http://www.nhlbi.nih.gov/crg/index.php

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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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UCSF's School of Medicine offers a variety or useful tools for clinical and drug trials - including forms, decision trees, checklists, pill diaries and more.   

From the University of California San Francisco School of Medicine.   http://www.medschool.ucsf.edu/clinical_research/tools/index.aspx

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CT Best Practices offers several tools for the reporting of adverse events and serious adverse events - including guidelines, an example IND safety report, and other resources.  

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

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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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CTN Best Practices provides links to a variety of reference resources (e.g., terminology, study phases) and calculators and conversion charts (e.g., BMI, height, weight, temperature).  

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

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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 PBRNs.  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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A very comprehensive sample operations manual for management of a project conducted at the University of Iowa. Includes a detailed study protocol as well as enrollment forms and procedures, notification of community providers, survey instruments, communications protocols and more.   Click here to download.

Courtesy of Barry Carter, PharmD. Professor and Associate Head for Research, Department of Family Medicine, Carver College of Medicine.  http://icts.uiowa.edu/taxonomy/term/34

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A very comprehensive sample operations manual for research assistants of a project conducted at the University of Iowa. Includes a detailed study protocol plus forms for faxing information from the RA to the PharmD (for example), as well as enrollment forms and procedures, notification of community providers, communications protocols and more.   Click here to download.

Courtesy of Barry Carter, PharmD. Professor and Associate Head for Research, Department of Family Medicine, Carver College of Medicine.  http://icts.uiowa.edu/taxonomy/term/34

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A nice example of how enrollment can be tracked and reported at each site for randomized trials and intervention studies.   Click here to download.

Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Lancet 2001; 357(9263):1191-1194.  http://www.consort-statement.org/consort-statement/flow-diagram/

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