Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulations

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Description of Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulations

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
* Investiga
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