Writing clinical research protocols : ethical considerations / Evan G. DeRenzo and Joel Moss.

Format:

Book

Author/Creator:

DeRenzo, Evan G.

Contributor:

Moss, Joel.

Language:

English

Subjects (All):

Clinical trials.

Medical protocols.

Physical Description:

1 online resource (321 p.)

Edition:

Second edition.

Place of Publication:

Burlington, MA ; London : Elsevier Academic, c2006.

Language Note:

English

Summary:

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

Contents:

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.

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

ISBN:

1-280-63341-7

9786610633418

0-08-045420-8

OCLC:

85766756

Publisher Number:

9780122107511