How to Calculate Clinical Study Drug Compliance and Accountability
You do not need to be a certified public accountant to correctly calculate study drug compliance and accountability. Many clinical research coordinators have a problem determining patient compliance with clinical study drug. Follow the instructions in this article, and you will get through the next monitoring visit or FDA inspection with flashing green lights.
- Difficulty:
- Easy
Instructions
Things You'll Need
- Calculator (or software)
- Basic pharmacy or clinical research knowledge
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1
Document study drug receipt.
Before you can calculate clinical study drug compliance, you must document the required information. To comply with regulations, keep a record of who, what, when, where, why and how. Who received the drug, what type container drug packaged in (blister packs, bottles, etc.), when did it arrive (date),etc.
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2
Document drug distribution.
Document to whom drug was given and the amount given. Tell the patient to keep track of the first date medication was taken and the last date study drug was taken.
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3
Calculate study drug compliance by taking the amount of drug ingested divided by the amount the patient should have ingested and multiply by 100.
At the next visit, check the medication and record the number of pills or tablets in the returned container. Record the date the patient took the first pill and the date the patient took the last pill. For example, the patient took the first pill on September 1st and the last pill on October 1st. The patient was given 100 pills and told to take 3 pills each day. The patient returned 7 pills at the next visit. From September 1 to October 1 is 31 days between doctor visits. 3 times 31 equal 93. If the patient returned 7 pills, then 100 minus 7 equal 93. The patient's compliance is 93 divided by 93 times 100 which is 100%.
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4
Other compliance considerations.
With the same scenario as the one above, suppose the patient returned 12 pills at the next visit. There is still 31 days between doctor visits so you subtract 12 from 100 which gives you 88. therefore, 88 divided by 93 times 100 make the patient's compliance 94.62%.
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5
Study Drug Accountability
To determine accountability, determine if the patient took the medication, lost some of the pills, or left some in a pillbox. Now, reconcile your clinical study drug records. On the log where you recorded the amount of medication received and dispensed, record the amount returned (and left in a pillbox or lost somehow) and make sure the numbers add up to 100. If the numbers don't add up to 100, you must write an explanation for the clinical study drug discrepancy.
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Tips & Warnings
If a subject did not return the medication for you to verify that the medicine bottle is either empty or have a certain number of pills remaining, compliance cannot be accurately calculated or determined. Without that container, you have no means of verifying compliance. You can document what the subject said in their source documents, but refer to the sponsor to determine if they want you to calculate compliance without verification, especially if it is an Alzheimer's study.
Determine if the subject left pills in a pillbox. this would affect the compliance calculations and will be useful for accountability. For example, the subject (above) could have taken 90 pills, left 3 in the pill box and return 7. this changes compliance to 96.8% instead of 100% and accountability would be 7 returned with 3 pills missing.
Keep an accurate inventory of all product received, dispensed and remaining onsite. For regulatory compliance, the FDA will check to see if you have an inventory log for all clinical study drug.
