Clinical research monitor handbook : GCP tools and techniques /: GCP tools and techniques. (1998)

• Record Type: Book
• Further Information: Note: Deborah Rosenbaum, Fred O. Smith.
• Other Names: Rosenbaum, Deborah; Smith, Fred (Fred O.)
• Contents: Overview of the Clinical Research Process; FDA Regulations and GCP Guidelines; Role of the CRA and Key Research Site Personnel; Designing a Clinical Study and Protocol Development; Data Management; The Study Investigational Agent; Selecting the Investigative Site; Pre-Study Sponsor Activities; Study Initiation; Adverse Event Monitoring; Management of the Clinical Research Site; Periodic Site Visits and Specific Monitoring Processes; Study Termination; Audits; Traveling; Independent Consulting
• Edition: 2nd ed
• Publisher Details: Boca Raton : Interpharm/CRC Press
• Publication Date: 1998
• Copyright Date: 2001
• Extent: 1 online resource (526 pages)
• Subjects: 615/.19/072; Clinical trials -- Standards -- Handbooks, manuals, etc; Clinical trials -- Evaluation -- Handbooks, manuals, etc; Clinical trials -- Law and legislation -- United States -- Handbooks, manuals, etc; Clinical trials -- Evaluation; Clinical trials -- Law and legislation; Clinical trials -- Standards; United States; Handbooks and manuals
• Languages: English
• ISBNs: 9781439805909; 1439805903
• Related ISBNs: 1574911252
• 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.