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The CRA's Guide to Monitoring Clinical Research :2nd Edition by Karen E. Woodin |
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Product 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. With current forms, ICH GCP information, FDA regulations, and other references, it shows readers how to manage a clinical research study effectively and efficiently.
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. With current forms, ICH GCP information, FDA regulations, and other references, it shows readers how to manage a clinical research study effectively and efficiently.
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Inside This Book
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First Sentence:
Clinical research is a vital part of health care. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
termination site visit, clinical hold order, proposed investigational use, exception from informed consent, drug accountability records, investigational agent, data flow sheets, recruiting study subjects, foreign clinical studies, proposed clinical investigation, expedited review procedure, general investigational plan, requirements for prior submission, accountability logs, one member whose primary concerns, information amendment, adverse drug experience, whose immediate direction, final study report, clinical research professionals, clinical research coordinators, lab requisitions, remote data entry, initiation visit, emergency research Key Phrases - Capitalized Phrases (CAPs): (learn more)
Applied Clinical Trials, Drug Information Journal, Case Report Forms, Clinical Research Coordinator, Federal Register, Research Nurse, Principal Investigator, Compliance Program Guidance Manual, Emergency Research, Good Clinical Practice, New York, Fishers Lane, Code of Federal Regulations, Evaluation of Gender Differences, Institutional Review Board Inspections, Monitoring Log, New Drug Application, Raven Press, Treatment Use of Investigational Drugs, Bioresearch Monitoring Program, Clinical Investigator Regulatory Sanctions, Declaration of Helsinki, Drug Study Designs, Freedom of Information, Graham Ball New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Clinical research is a vital part of health care. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
termination site visit, clinical hold order, proposed investigational use, exception from informed consent, drug accountability records, investigational agent, data flow sheets, recruiting study subjects, foreign clinical studies, proposed clinical investigation, expedited review procedure, general investigational plan, requirements for prior submission, accountability logs, one member whose primary concerns, information amendment, adverse drug experience, whose immediate direction, final study report, clinical research professionals, clinical research coordinators, lab requisitions, remote data entry, initiation visit, emergency research Key Phrases - Capitalized Phrases (CAPs): (learn more)
Applied Clinical Trials, Drug Information Journal, Case Report Forms, Clinical Research Coordinator, Federal Register, Research Nurse, Principal Investigator, Compliance Program Guidance Manual, Emergency Research, Good Clinical Practice, New York, Fishers Lane, Code of Federal Regulations, Evaluation of Gender Differences, Institutional Review Board Inspections, Monitoring Log, New Drug Application, Raven Press, Treatment Use of Investigational Drugs, Bioresearch Monitoring Program, Clinical Investigator Regulatory Sanctions, Declaration of Helsinki, Drug Study Designs, Freedom of Information, Graham Ball New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
This book cites 80
books:
See all 80 books this book cites
- Clinical Drug Trials And Tribulations, Revised And Expanded (Drugs and the Pharmaceutical Sciences) by Cato on page 58, and page 107
- Automated Microbial Identification and Quantitation: Technologies for the 2000s by Wayne P. Olson in Back Matter
- Write it Down: Guidance for Preparing Effective and Compliant Documentation, Second Edition by Janet Gough in Back Matter
- Quality Rules in Active Pharmaceutical Ingredients Manufacture: American Edition (5-pack) by John Sharp in Back Matter
- Validation and Qualification in Analytical Laboratories by Ludwig Huber in Back Matter
See all 80 books this book cites
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37% buy the item featured on this page: Clinical Research Coordinator Handbook: GCP Tools and Techniques, Second Edition (Practical Clinical Trials) $299.95 |
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18% buy Responsible Research: A Guide For Coordinator's $28.92 |
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15% buy The CRC's Guide to Coordinating Clinical Research $79.00 |
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