Module 6: Exercise 4: Standard Operating Procedure
Create a checklist for site study closeout from the perspective of a clinical site.
For the checklist, specify the close-out task and the responsible person. For example, ensure all IMP records are complete and organized: pharmacist, or study coordinator. You must specify 8-10 tasks.
Grading:
Formatting, flow and grammar-10 points
Content – 50 points
Applicability – 10 points (can this be used at an hypothetical site)
Consistency – 10 points
Total = 80 points
Worth 80 points
Pfeiffer, J and Wells, C (2017). A Practical Guide to Managing Clinical Trials. CRC Press. ISBN: 978-1-138-1965
Shah, K, Wells, C and Pfeiffer, J (2017). A Clinical Trial Workbook: Material to
Complement Research Education and Training Programs. LAD Custom Publishing, Inc (Edition 2)
ISBN 978-0-8401-3527-8
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