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W‌‍‍‍‌‍‍‌‌‍‍‍‌‍‍‍‍‌‍‍hat to do: Review the instructions for this week’s assignment. Objectives Discuss best practices and guidelines for drug accountability and patient compliance in clinical drug trials. Directions In a 3 page paper, describe the purpose and associated regulations for drug accountability and medication compliance tracking in clinical research. How might this topic relate to SOPs and Study Initiation and Study Closure? Using the log below, complete and insert a drug accountability record for the mock case. Note any compliance issues. What is percentage of expected pill intake did the patient show between visit 3 and 4? Describe methods to improve patient adherence. CASE STUDY In a double-blind hypertension study, the coordinator will dispense study medication for the randomized patient for visit 4 from study drug supply that is located i‌‍‍‍‌‍‍‌‌‍‍‍‌‍‍‍‍‌‍‍n a locked closet at her research site. She will collect study medication that had been dispenses at Visit 3 and calculate compliance before dispensing the next supply of study drug to the patient. Patients are instructed to take one pill at bedtime. Study visits occur 30 days apart with a study visit window allowance of +/- 3 days (., Day 30 +/- 3 days) Patient ID- 002 Dispensed at Visit 3 on 5/1/15- Study Drug (Lot number 3058). Total pills in the bottle: 35. Next appointment. 6/2/15. Collected at Visit 4 on 6/2/15- Study Drug (lot number 3058). Total pills left in bottle: 15. Dispensed at Visit 4 on 6/2/15- Study Drug (lot number 4122). Total pills dispensed: 35. Next appointment 7/1/15. Complete a drug accountability log using the table below. You can recreate and complete (or cut and paste) the table within your paper‌‍‍‍‌‍‍‌‌‍‍‍‌‍‍‍‍‌‍‍.


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