Physician investigator handbook : GCP tools and techniques /: GCP tools and techniques. (©2001)

• Record Type: Book
• Further Information: Note: Deborah Rosenbaum, Fred Smith.
• Other Names: Rosenbaum, Deborah; Smith, Fred (Fred O.)
• Contents: Front Cover; Contents; Introduction; Chapter 1: Overview and Elements of Clinical Research; General Goals; Who Conducts Clinical Research?; The Drug Development Process; Phases of Clinical Research; Basic Elements of Clinical Research; Resources; Bibliography; Chapter 2: The Physician as Investigator; Qualifications of the Principal Investigator; The Investigative Staff; Subinvestigators; The Role of the Clinical Research Coordinator in Clinical Research; Support Staff: Administrative, Pharmacy, and Hospital; The Study Work Area; Investigator Responsibilities to the Institutional Review Board. Informed ConsentRecordkeeping Responsibilities; Supervisory Responsibilities; Bibliography; Chapter 3: Professional Interactions; The Institutional Review Board; Pharmacy; Laboratories and Medical Imaging; Emergency Room (ER) and Intensive Care Unit (ICU); Communication Strategies; Study Coordination; Preparing Hospital Staff; Bibliography; Chapter 4: FDA Regulations and Good Clinical Practice Guidelines; Code of Federal Regulations; ICH GCP Guideline; Responsibilities of the Investigator; Responsibilities of the Sponsor; Sponsor Investigator Status. Financial Disclosure by Clinical InvestigatorsElectronic Signature (21 CFR 11); The Institutional Review Board; Subject Informed Consent; Regulatory References; Contacts; Bibliography; Chapter 5: Investigational Agent Management; Investigational Drug Agents in a Clinical Trial; Packaging of Investigational Agent; Study Drug Labels; Receiving and Storing the Investigational Agent; Dispensing the Investigational Drug Agent; Instructions to Study Subjects; Study Drug Accountability; Code Breakers; Destruction of the Investigational Agent-Final Disposition; Common Questions; Regulatory References. The Planning Stage of a StudyStudy Commencement; Keeping Up with the Study; Study Termination; Regulatory Reference; Bibliography; Chapter 9: Monitoring of Clinical Trials; Site Monitoring Visits; Grant-Sponsored Visits (Audits and Inspections); Resolution of Problems Identified at Site Visits; Telephone Monitoring; Written Correspondence; Investigator's Meetings; Study Procedures Manual; Bibliography; Chapter 10: Interactions with the Study Subject; Subject Recruiting; Subject Screening; Subject Enrollment; Subject Retention; Bibliography; Chapter 11: Adverse Events and Drug Safety.
• Edition: Second edition
• Publisher Details: Englewood, CO : IHS Health Group
• Publication Date: 2001
• Copyright Date: 2001
• Extent: 1 online resource (x, 471 pages (loose-leaf)), illustrations
• Subjects: 610/.72; Clinical trials; Clinical trials -- Law and legislation -- United States; Drugs -- Testing -- Standards; Drugs -- Testing -- Law and legislation -- United States; Clinical Trials -- standards; Clinical Trials -- methods; Physicians; Practice Guidelines as Topic; Clinical trials -- Law and legislation -- United States; Clinical Trials -- methods; Clinical Trials -- standards; Clinical trials; Drugs -- Testing -- Law and legislation -- United States; Drugs -- Testing -- Standards; Physicians; Practice Guidelines; MEDICAL -- Research; Clinical trials; Clinical trials -- Law and legislation; Drugs -- Testing -- Law and legislation; Drugs -- Testing -- Standards; United States; Electronic books
• Languages: English
• ISBNs: 9781420025934; 1420025937; 9781574911244; 1574911244
• Related ISBNs: 1574911244
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.