Contents:

Additional Elements

NonEnglishSpeaking Subjects and Translation of Consent Documents

Ethics of Data Sharing and Handling

Reidentification Models Methods and Applications 44

Regulatory Approval 75

Data Collection and Management Plan

Data Cleaning and Lock 111

Budgeting Process and Management

This book will serve as a road map for students and junior researchers seeking to successfully design, implement, and publish clinical research. It covers the basic elements of research proposals and implementation including regulatory approvals, continuing regulatory oversight, investigational new drug and device applications, monitoring patient safety, recruitment, clinical assessments, laboratory assessments, provision of treatment, and on-going quality control. The authors provide instruction on how to integrate research resources to successfully conduct a clinical research project, and offer guidelines on collection, quality control, and analysis of data. A companion website will include the fully searchable text and links to Journal of Investigative Medicine's "Research Tools and Issues" feature. Common terms and phrases: activities additional Administration analysis and/or applicable appropriate approved assure authorization benefits blood Board budget Center changes clinical research clinical trial collected complete conduct Confidentiality consider costs database defined described determine device discuss document drug effects elements enrollment ethical evaluation example federal findings funding health information HIPAA human identifiers important individual informed consent initial insert insert name institution Introduction investigator involved issues limited means meet methods monitoring obtain participants patient payment person possible potential problem procedures proposed protection protocol questions radiation reason receive records recruitment regulations request research study responsible risk safety sample screening share specific sponsor staff standard statistical study subject Table tests tion treatment understand writing