'Investigator brochure' presentation slideshows

Quality Improvement and Human Subjects Protection Program

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Verifying Source Documents

Verifying Source Documents. Source Documentation. First place the data are captured Original documents, data, and records Certified Copies Should contain certain specific information about the participant and trial. Working Definition of Source Documents.

796 views • 42 slides

Investigator Study File

Investigator Study File. Developed by Klinikos; Roy Fraser (2012). CONTAINS ESSENTIAL DOCUMENTS THAT ALLOWS EVALUATION OF THE CONDUCT OF THE TRIAL SERVES TO DOMONSTRATE COMPLIANCE WITH ICH-GCP. Investigator study file purpose. Contact Sheet Log of Monitoring Visits

587 views • 22 slides