Cargando…

Writing clinical research protocols : ethical considerations /

This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, designing appropriate research stu...

Descripción completa

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: DeRenzo, Evan G.
Otros Autores: Moss, Joel
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Burlington, MA ; London : Elsevier Academic, �2006.
Temas:
Acceso en línea:Texto completo

MARC

LEADER 00000cam a2200000 a 4500
001 SCIDIR_ocn162571734
003 OCoLC
005 20231117014927.0
006 m o d
007 cr cn|||||||||
008 070806s2006 mau ob 001 0 eng d
040 |a OPELS  |b eng  |e pn  |c OPELS  |d OKU  |d OCLCQ  |d N$T  |d YDXCP  |d OCLCO  |d EBLCP  |d MHW  |d MERUC  |d UKWOH  |d IDEBK  |d UBY  |d E7B  |d OCLCQ  |d OCLCF  |d OCLCQ  |d NLGGC  |d CHVBK  |d NRU  |d OCLCQ  |d AGLDB  |d STF  |d CCO  |d MOR  |d PHUST  |d OCLCO  |d IQW  |d JBG  |d OCLCO  |d PIFAG  |d ZCU  |d OCLCQ  |d CASUM  |d OCLCO  |d U3W  |d OCLCA  |d MNS  |d OCLCO  |d KIJ  |d WRM  |d VNS  |d OCLCO  |d D6H  |d OCLCO  |d ACO  |d WCO  |d OCLCO  |d OCLCQ  |d VTS  |d OCLCO  |d NRAMU  |d XOS  |d ICG  |d OCLCO  |d OCLCQ  |d VT2  |d REC  |d OCLCO  |d AU@  |d OCLCO  |d OCLCQ  |d OCLCO  |d WYU  |d OCLCO  |d S9I  |d TKN  |d OCLCO  |d LEAUB  |d OCLCO  |d DKC  |d OCLCO  |d OCLCQ  |d OCLCO  |d M8D  |d OCLCO  |d OL$  |d OCLCQ  |d OCLCO  |d OCLCQ  |d K6U  |d OCLCA  |d VLY  |d OCLCQ  |d OCLCO  |d OCLCQ  |d IOY  |d OCLCQ  |d OCL  |d OCLCO 
015 |a GBA4Y1082  |2 bnb 
016 7 |a 101258295  |2 DNLM 
019 |a 76697795  |a 85766756  |a 441762043  |a 505064176  |a 647545036  |a 701878860  |a 814467746  |a 823136810  |a 843151739  |a 961552298  |a 962560748  |a 1162253939  |a 1228531159 
020 |a 9780122107511 
020 |a 0122107519 
020 |a 0080454208  |q (electronic bk.) 
020 |a 9780080454207  |q (electronic bk.) 
020 |a 1280633417 
020 |a 9781280633416 
020 |a 9786610633418 
020 |a 661063341X 
024 3 |z 9780122107511 
035 |a (OCoLC)162571734  |z (OCoLC)76697795  |z (OCoLC)85766756  |z (OCoLC)441762043  |z (OCoLC)505064176  |z (OCoLC)647545036  |z (OCoLC)701878860  |z (OCoLC)814467746  |z (OCoLC)823136810  |z (OCoLC)843151739  |z (OCoLC)961552298  |z (OCoLC)962560748  |z (OCoLC)1162253939  |z (OCoLC)1228531159 
050 4 |a R853.P75  |b D47 2006eb 
060 4 |a 2005 L-599 
060 4 |a W 20.5  |b D431w 2006 
072 7 |a HEA  |x 032000  |2 bisacsh 
072 7 |a MED  |x 034000  |2 bisacsh 
072 7 |a HEA  |x 009000  |2 bisacsh 
072 7 |a OCC  |x 011000  |2 bisacsh 
072 7 |a MJ  |2 bicssc 
082 0 4 |a 615.50724  |2 22 
100 1 |a DeRenzo, Evan G. 
245 1 0 |a Writing clinical research protocols :  |b ethical considerations /  |c Evan G. DeRenzo and Joel Moss. 
260 |a Burlington, MA ;  |a London :  |b Elsevier Academic,  |c �2006. 
300 |a 1 online resource (xix, 300 pages) 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
347 |a data file 
504 |a Includes bibliographical references and index. 
505 0 |a Introduction to the art and science of clinical research -- What you need to know about clinical research ethics -- What you need to know about the regulation of clinical research -- Designing a clinical research study -- Selecting subjects for clinical studies -- Risks and benefits in clinical research -- Recruiting subjects -- Informed consent -- Privacy and confidentiality -- The "ethics" section -- Procedures and methods -- Statistics, data collection and management, and record keeping -- Use of human biological materials -- Special issues raised by evolving areas of clinical research -- Case histories : learning from experience. 
520 |a This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This will be an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. * Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol * Includes a chapter containing Case Histories * Contains information on conducting clinical research within the pharmaceutical industry * An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations * Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations. 
505 0 |a What You Need To Know About Research Ethics Before Deciding on What You Want To Study -- Designing a Clinical Research Study -- Writing Consent and Assent Documents -- Getting the Protocol Approved -- Conducting the Study; Special Populations -- Ethical Considerations in Genetics Research -- Ethical Considerations in Use of Tissue for Laboratory Investigations -- Ethical Considerations in Use of Stored Tissue -- Confidentiality Issues -- Research in Emergency Medicine -- Reporting of Adverse Events -- FDA -- Radiation Safety Issues -- Participation of Subjects in Multi-Site Trials -- Participation of Subjects in Multiple Studies -- Conduct of Pharmaceutical Industry Research -- Case Histories, Learning from Experience -- Appendix. 
588 0 |a Print version record. 
546 |a English. 
650 0 |a Clinical trials. 
650 0 |a Human experimentation in medicine. 
650 0 |a Medical protocols. 
650 0 |a Writing. 
650 0 2 |a Biology  |x research 
650 0 2 |a Clinical Trials 
650 1 2 |a Human Experimentation  |0 (DNLM)D006805 
650 1 2 |a Clinical Protocols  |0 (DNLM)D002985 
650 1 2 |a Writing  |0 (DNLM)D014956 
650 1 2 |a Ethics  |0 (DNLM)D004989 
650 1 2 |a Biomedical Research  |x ethics  |0 (DNLM)D035843Q000941 
650 1 2 |a Clinical Protocols  |x standards  |0 (DNLM)D002985Q000592 
650 6 |a �Etudes cliniques.  |0 (CaQQLa)201-0070699 
650 6 |a Exp�erimentation humaine en m�edecine.  |0 (CaQQLa)201-0070698 
650 6 |a Protocoles m�edicaux.  |0 (CaQQLa)201-0062174 
650 6 |a �Ecriture.  |0 (CaQQLa)201-0010045 
650 7 |a writing (processes)  |2 aat  |0 (CStmoGRI)aat300054698 
650 7 |a HEALTH & FITNESS  |x Alternative Therapies.  |2 bisacsh 
650 7 |a MEDICAL  |x Healing.  |2 bisacsh 
650 7 |a HEALTH & FITNESS  |x Healing.  |2 bisacsh 
650 7 |a BODY, MIND & SPIRIT  |x Healing  |x General.  |2 bisacsh 
650 7 |a Writing  |2 fast  |0 (OCoLC)fst01181638 
650 7 |a Medical protocols  |2 fast  |0 (OCoLC)fst01014534 
650 7 |a Human experimentation in medicine  |2 fast  |0 (OCoLC)fst00963042 
650 7 |a Clinical trials  |2 fast  |0 (OCoLC)fst00864429 
655 0 |a Electronic books. 
655 2 |a Electronic information resources [MESH] 
655 2 |a Electronic information resources 
700 1 |a Moss, Joel. 
776 0 8 |i Print version:  |a DeRenzo, Evan G.  |t Writing clinical research protocols.  |d Burlington, MA ; London : Elsevier Academic, �2006  |z 9780122107511  |z 0122107519  |w (OCoLC)56453025 
856 4 0 |u https://sciencedirect.uam.elogim.com/science/book/9780122107511  |z Texto completo