85,13 €
94,59 €
-10% with code: EXTRA
Good Clinical Practice
Good Clinical Practice
85,13 €
94,59 €
  • We will send in 10–14 business days.
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 * Clinica…
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Good Clinical Practice (e-book) (used book) | bookbook.eu

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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

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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

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