Developing a Successful Clinical Research Program - Cara East

Blick ins Buch

Developing a Successful Clinical Research Program (eBook)

Cara East (Autor)

eBook Download: PDF

2018 | 1st ed. 2018
XIX, 270 Seiten
Springer International Publishing (Verlag)
978-3-319-54693-3 (ISBN)

Lese- und Medienproben

Ebook-Leseprobe (PDF)

This unique book is designed to help a medical team become a clinical research team. It includes practical information and tips for the initial stages of clinical research: building a team, negotiating a contract, developing a budget, and writing and improving a patient consent. Chapters describing the nuts and bolts of how to actually perform the study follow, including patient recruiting and retention, screening, follow-ups and handling monitor visits. Finally, there is discussion of the yearly reviews and disclosures and not just surviving, but acing, the all-important Food and Drug Administration audit.

Clinical research moves medicine forward and is a necessary part of bringing any new therapy, device, or procedure into routine medical care. However, it can be costly and convoluted, and the methodologies of clinical research are not widely standardized. Decreasing some of the chaos present in American clinical research is the primary goal of this book. The second goal is to improve the understanding and education of those who enter clinical research, whether in the frontline work of the clinical research site, in the middleman companies who have a high turnover rate, at a research hospital or institution, or at medical corporations that depend on good clinical research to bring their products to market. The third reason is to standardize American clinical research and to remove some of the vagaries and inconsistencies in the field.

Practical and user-friendly, Developing a Successful Clinical Research Program fills a need for a clear guide to developing and improving a first-class research program in any clinical setting.

Cara East, MD, FACP, Texas Heart Center, Director, Soltero Cardiovascular Research Center, Baylor University Medical Center, Dallas, TX, USA

Why Do Clinical Research?- How Clinical Research Should Never Have Been Done: Ethical Measures for Protection and Respect.- Choosing Studies.- Starting Clinical Research.- Developing a Budget.- Negotiating a Contract.- Writing a Great Informed Consent (IC).- Starting the Study.- Regulatory Startup.- Recruiting.- Getting Subjects through the Door.- The Screening Visit.- Follow-up Visits.- Maintaining Subject Retention and Avoiding Study Fatigue.- Adverse Events (AE’s) and Protocol Deviations.- Contact Research Organizations (CRO’s) and Monitors.- Annual Review and Financial Disclosures.- Finishing a Study.- Staff Training and Incentives.- Study Closeout.- Acing an Audit.- Expanding the Team.- Epilogue: Watching Medicine Evolve.- Appendices.

Erscheint lt. Verlag	8.8.2018
Zusatzinfo	XIX, 270 p. 10 illus., 2 illus. in color.
Verlagsort	Cham
Sprache	englisch
Themenwelt	Medizin / Pharmazie ► Allgemeines / Lexika
Schlagworte	Adverse Event • Auditing • Budgeting • Clinical research team • Clinical staff training • Clinical Trials • contract negotiation • Financial disclosure • Informed Consent • Medical study • Patient recruiting • Regulatory review • Research Methodology • Screening visit • Subject retention • Subject screening
ISBN-10	3-319-54693-7 / 3319546937
ISBN-13	978-3-319-54693-3 / 9783319546933

Haben Sie eine Frage zum Produkt?

PDF (Wasserzeichen)
Größe: 3,3 MB

DRM: Digitales Wasserzeichen
Dieses eBook enthält ein digitales Wasserzeichen und ist damit für Sie personalisiert. Bei einer missbräuchlichen Weitergabe des eBooks an Dritte ist eine Rückverfolgung an die Quelle möglich.

Dateiformat: PDF (Portable Document Format)
Mit einem festen Seitenlayout eignet sich die PDF besonders für Fachbücher mit Spalten, Tabellen und Abbildungen. Eine PDF kann auf fast allen Geräten angezeigt werden, ist aber für kleine Displays (Smartphone, eReader) nur eingeschränkt geeignet.

Systemvoraussetzungen:
PC/Mac: Mit einem PC oder Mac können Sie dieses eBook lesen. Sie benötigen dafür einen PDF-Viewer - z.B. den Adobe Reader oder Adobe Digital Editions.
eReader: Dieses eBook kann mit (fast) allen eBook-Readern gelesen werden. Mit dem amazon-Kindle ist es aber nicht kompatibel.
Smartphone/Tablet: Egal ob Apple oder Android, dieses eBook können Sie lesen. Sie benötigen dafür einen PDF-Viewer - z.B. die kostenlose Adobe Digital Editions-App.

Buying eBooks from abroad
For tax law reasons we can sell eBooks just within Germany and Switzerland. Regrettably we cannot fulfill eBook-orders from other countries.

Print-Ausgabe

Buch | Softcover

80,24 €