Clinical Research Coordinator Handbook: GCP Tools and Techniques, Second Edition
By Deborah Rosenbaum, Michelle Dresser,
Publisher: Informa Healthcare
Number Of Pages: 342
Publication Date: 2001-10-01
Sales Rank: 1253704
ISBN / ASIN: 1574911236
EAN: 9781574911237
Binding: Loose Leaf
Book Description:
This revised edition of a bestseller provides a logical, step-by-step guide to testing new drugs and treatment modalities in compliance with the latest FDA regulations. Using current forms, ICH GCP information, FDA regulations, and other references, it shows readers how to manage a clinical research study effectively and efficiently. Chapters include: Overview of Clinical Research, FDA Regulations and Good Clinical Practice Guidelines, The Study: Planning Stages and Commencement, Interactions with the Sponsor, Interactions Within the Institution; The Role of the Study Subjects, Data Management: Adverse Events, Investigational Agent Management, and Inspection of Clinical Research Sites.
Publisher: Informa Healthcare
Number Of Pages: 342
Publication Date: 2001-10-01
Sales Rank: 1253704
ISBN / ASIN: 1574911236
EAN: 9781574911237
Binding: Loose Leaf
Book Description:
This revised edition of a bestseller provides a logical, step-by-step guide to testing new drugs and treatment modalities in compliance with the latest FDA regulations. Using current forms, ICH GCP information, FDA regulations, and other references, it shows readers how to manage a clinical research study effectively and efficiently. Chapters include: Overview of Clinical Research, FDA Regulations and Good Clinical Practice Guidelines, The Study: Planning Stages and Commencement, Interactions with the Sponsor, Interactions Within the Institution; The Role of the Study Subjects, Data Management: Adverse Events, Investigational Agent Management, and Inspection of Clinical Research Sites.
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