000			02977nam a22003017a 4500
003			OSt
005			20240305192450.0
008			220607b |||||||| |||| 00| 0 eng d
020			_a 145115335X
020			_a9781451153354
040			_cdlc
050			_aW 20.5 C64115 2011
050			_aR853.C55C55 2011
082			_a615.5072’4—dc22
100			_aRobert D. Toto _938629
245			_aClinical Research _b From Proposal to Implementation
260			_aLondon _bLippincott Williams & Wilkins _c2012
300			_a 256 pages
505			_aContents: 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
520			_aThis 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. _bCommon 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
600			_x Medical / Public Health _928323
600			_x Medical › Public Health _938630
600			_x Biomedical Research—methods. _938631
600			_xClinical Trials as Topic—methods. _938632
600			_xResearch Design. _931702
700			_a Michael J. McPhaul _938633
942			_2ddc _cEB
999			_c7021 _d7021