Compliance data only comes in-house for a given subject at years 1, 2 and 4 (with running logs). Hence the numbers shown in the "Due" column accordingly. For example, if a subject was randomized on June 1 2004 then compliance data for visits 1-4 should be sent in on June 1 2005, compliance data for visits 5-6 should be sent in on June 1 2006 and compliance data for visits 7-10 should be sent in on June 1 2008. (Matt's e-mail: Tue, 17 May 2005 11:39:13)

At each dispensing visit the subject is supposed to be given two bottles of pills with 100 pills per bottle. The subject takes one pill per day and at the next visit the subject returns the unused pills. Hence, a subject who takes his pills as prescribed should use about 182 pills (6 months worth) and then return the remaining 18. Since the prescribed amount is 1 pill per day the total # of prescribed pills can vary based on the duration between visits - that is why we compute the total # of prescribed pills as I detailed in my email below. (Matt: Wed, 5 Oct 2005 15:53:51 )

For # of days between dispensing dates include the day dispensed (beginning of period) but not the day of the next dispense date. Hence if first dispense date = January 1, 2005 and the next dispense date = January 20, 2005 then # of days = 19 (i.e., for Jan 1-19). Note that an adjustment is needed for the final dispensing period since you will have the dispense date at beginning of period and then will have a date of last dose of study drug (no next dispense date). Hence in that case you would include both the beginning dispense date and the date of last dose.(Matt: Thu, 6 Oct 2005 15:41:47)

There are occasional cases in which a subject has additional study medication dispensed prior to the next visit. This could happen, for instance, when it took longer than usual for all qualifying assessments to be completed prior to the scheduled date for visit 2. In such a situation the site may delay visit 2, issue additional study drug, and record. Hence for compliance purposes you can add the numbers dispensed, etc. within the visit and then do the usual calculations.(Matt's e-mail: Tue, 17 May 2005 11:39:13)
Topic revision: r2 - 19 Oct 2005, SvetlanaEden
 

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