Reflection – Clinical Research Monitoring

Compare the similarities and differences of site-based (including risk based monitoring) and central monitoring plans and analytics used in clinical trials.

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Direction on Paper:  In 500 words or less (PLUS OR MINUS 50 WORDS WHICH IS WORTH 10 POINTS FOR COMPLIANCE), reflect on what you have learned in this course to address the following three points:

Required:  The role of monitoring in ensuring accurate and complete data for the approval of investigational medical products. (25 points)

(incorporate Subcategory Option 1, 2, or 3 (only one is necessary) about centralized monitoring into your paper

            = Option 1 of 3 .: incorporate here how central monitoring (and analytics) may have impacted monitoring

Required:  Monitoring studies in contrast to audits and inspections. (25 points)

            = Option 2 of 3: incorporate how central monitoring/analytics is compares/contrasts to audit and inspections

Required: Monitoring to ensure site compliance with applicable regulations and GCPs. (25 points)

            =Option 3 of 3: how does centralized monitoring and analytics help with these items

APA style not required Reminders: YOUR name on submission title, introduction (5 points), conclusion (5 points), references (required as this project would not be possible without them) (5 points).

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