| Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulati Contributor(s): Allport-Settle, Mindy J. (Author) |
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ISBN: 0982147678 ISBN-13: 9780982147672 Publisher: Pharmalogika OUR PRICE: $44.64 Product Type: Paperback - Other Formats Published: August 2010 |
| Additional Information |
| BISAC Categories: - Medical | Clinical Medicine |
| Physical Information: 1.42" H x 5.98" W x 9.02" (2.06 lbs) 712 pages |
| Descriptions, Reviews, Etc. |
| Publisher Description: Topics covered include: * A brief description of the history and development of clinical research and good clinical practice * Title 21 CFR Parts 11, 50, 54, 56, 58, 210, 312, 314, 320, 511, 514, 601, 812, and 814 * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data/Documentation * Investigator/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols/Protocol Changes/Protocol Violations * Institutional Review Boards * Quality Assurance Activities/Study Auditing/FDA Inspections * Investigational Drug Accountability, Administration, and Labeling |