Launching and Managing Studies


Evidence-Based Medicine Educational Series

6-lecture series presented by Dr. Robert A. Harrington of Duke University School of Medicine and Karen Pieper of the Duke Clinical Research Institute and available through the CTN Best Practices website. Designed for investigators and staff with limited formal training in quantitative science, the series addresses statistical issues in trial design, interpretation of statistics in medical literature, methods for statistical analyses, and data and safety monitoring boards.   

From Clinical Trials Networks Best Practices (CTNBP) of Duke Clinical Research Institute (DCRI). Presented by the Duke Clinical Research Institute Statistics group and CTN Best Practices principal investigator, Robert A. Harrington, MD.  https://www.ctnbestpractices.org/edu/ebm/

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Social Research Methods Knowledge Base

This link will take you to an online research methods textbook, which provides instruction on both theoretical and applied aspects of the research process. Accessibly written and replete with good examples, the Knowledge Base is suitable for training new staff or brushing up on measurement or basic statistical concepts.   

Trochim, William M. The Research Methods Knowledge Base, 2nd Edition. Copyright ©2006. Internet WWW page, at URL: .  www.socialresearchmethods.net

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ACCESS Orientation of a Researcher to a Clinic

This is a sample orientation checklist for external research staff who will be working in a health care setting. The simple form outlines topics around which to set expectations, documents that training occurred, and sets out a communication pathway for future questions. This example could serve as a template for practices working to operationalize research policies and create best practices.   Click here to download.

Courtesy of the ACCESS Community Health Network of Chicago, Illinois.  http://www.accesscommunityhealth.net/

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HMORN Interviewer Training Manual

This manual is intended to be an introduction to interviewing for people who have never been formally trained in survey research telephone interviewing. Topics covered are professional ethics, introduction to interviewing, general interviewing practices, active listening, refusal avoidance, and additional considerations for in-person interviewing. A section on in-person interviewing is also included.  Click here to download.

From the HMO Research Network Collaboration Toolkit.  www.hmoresearchnetwork.org

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CTNBP Training: Building a Successful Research Site

This 9-module training program from CTN Best Practices addresses principal investigator obligations, regulatory environment, NIH trials, study coordinator training, facility setup, study feasibility/protocol assessment, subject recruitment and retention, budget management, and site availability announcements. Estimated time to complete: 3 hours.   

From Clinical Trials Networks Best Practices (CTNBP) of Duke Clinical Research Institute (DCRI).  https://www.ctnbestpractices.org/edu/keys-to-building-a-successful-research-site/

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NHLBI Preparing, Submitting and Managing Grants Guide

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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