Engaged. Knowledge. Application
GCP CONTENT Packages
➢Clinical Monitoring CONTENT Power Package
This ninety-five (95) page package contains seventeen (17) documents for three clinical study monitoring stages (Pre-Study, Interim and Close-out) including: Three (3) SOPs, Three (3) Visit Reports, Application Guide Reference Article, PDF PowerPoint Training Presentation and Trainer Instructional Notes, six (6) Letters (Examples), Feasibility Questionnaire and more, including Read More - Click Here..
➢Institutional Review Board (IRB) CONTENT Package
This comprehensive package includes a content reference article, PowerPoint presentation, and trainer instructional notes. Read More - Click Here..
➢FDA GCP Enforcement Trends CONTENT Package
This one hour webinar recording and PowerPoint training presentation review a number of critical regulatory agency GCP noncompliance trends that have appeared as audit observations in FDA Warning Letters and other regulatory agencies observations over the past couple of years. Read More - Click Here..
➢Clinical Trial Protocols CONTENT Package
This comprehensive package includes a content reference article, PowerPoint presentation, and trainer instructional notes. Read More - Click Here..
➢Ensuring GCP Quality CONTENT Package
This comprehensive package includes two content reference articles, PowerPoint presentation, and trainer instructional notes. Read More - Click Here...
➢Scientific Misconduct/Suspected Fraud CONTENT Package
This comprehensive package includes a content reference article, corporate policy template, powerpoint presentation, and trainer instructional notes. Read More - Click Here...
➢Informed Consent CONTENT Package
This comprehensive package includes a content reference article, auditing checklist, powerpoint presentation, and trainer instructional notes. Read More - Click Here...
➢Adverse Event CONTENT Package
This comprehensive package includes a content reference article, SOP, powerpoint presentation, and trainer instructional notes.Read More - Click Here...
➢FDA Inspections of Clinical Research Sites: A Preparation Primer
This 20+ Page "how to" instructional article includes the following.. Read More - Click Here..
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