Study Drug Dosing by shuifanglj

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									                                                                               Study Drug Dosing                                          Page __ of __
                     [Study Name/ID pre-filled]                                                           Site Name: ________________________

                                                                                                          Subject ID: _________________


To be completed at every study contact when the participant/subject is prescribed study drug. This form should be used in conjunction with the Study
Drug Compliance form.
                                      Dose Units                                                                Dose Frequency
              g = gram            mg = milligram        TBSP = tablespoon       BID = twice daily          q6h = every 6 hours         QPM = one dose in evening
              gr = grain          mL = milliliter       tsp = teaspoon          TID = three times a day    q8h = every 8 hours         HS = at bedtime
              gtt = drop          oz = ounce            OTH = other, specify    QID = four times a day     QAM = one dose in morning   PRN = as needed
              mcg = microgram     SPY = spray/squirt    UNK = unknown           q2h = every 2 hours        QD = once daily             OTH = other, specify
              mcL = microliter    supp = suppository                            q4h = every 4 hours                                    UNK = unknown


                                      Start Time of                                              End Time of
            Start Date of                                           End Date of                                             Dose                              Dose
                                       Study Drug                                                Study Drug                              Dose Units
            Study Drug                                              Study Drug                                             Amount                          Frequency
                                         (HH:MM)                                                    (HH:MM)
                                      __ __ : __ __                                               __ __ : __ __
        ____/_____/20______                                    ____/_____/20______
            (mm/dd/yyyy)                 am      pm                (mm/dd/yyyy)                      am      pm
                                        24-hour clock                                               24-hour clock
                                      __ __ : __ __                                               __ __ : __ __
        ____/_____/20______                                    ____/_____/20______
            (mm/dd/yyyy)                 am      pm                (mm/dd/yyyy)                      am      pm
                                        24-hour clock                                               24-hour clock
                                      __ __ : __ __                                               __ __ : __ __
        ____/_____/20______                                    ____/_____/20______
            (mm/dd/yyyy)                 am      pm                (mm/dd/yyyy)                      am      pm
                                        24-hour clock                                               24-hour clock
                                      __ __ : __ __                                               __ __ : __ __
        ____/_____/20______                                    ____/_____/20______
            (mm/dd/yyyy)                 am      pm                (mm/dd/yyyy)                      am      pm
                                        24-hour clock                                               24-hour clock
                                      __ __ : __ __                                               __ __ : __ __
        ____/_____/20______                                    ____/_____/20______
            (mm/dd/yyyy)                 am      pm                (mm/dd/yyyy)                      am      pm
                                        24-hour clock                                               24-hour clock




Core Version 3.0
                       Study Drug Dosing CRF Module Instructions                    Page 1 of 1


GENERAL INSTRUCTIONS
The Study Drug Dosing form tracks the study drug dosing regimen for an individual study
participant/subject across the duration of the study in a log format. This form can also be used
for biologics. Additional pages may be required to capture the number of doses included in each
study. For this reason, page numbers should be recorded. The Study Drug Dosing form should
be used in conjunction with the Study Drug Compliance form.

For each dosing record the Start Date, Stop Date, Dose Amount, Dose Unit, and Dose
Frequency should be recorded. Start Time and Stop Time may be important for some studies
but not applicable in others; these data elements should be included or excluded from the Study
Drug Dosing form as appropriate for the study.


SPECIFIC INSTRUCTIONS
Please see the Data Dictionary for definitions for each of the data elements included in this CRF
Module.
   Start Date – Record the calendar date the participant/subject was prescribed to start taking
    study drug.
   Start Time – Record the clock time the participant/subject was prescribed to start taking
    study drug. Also record the unit for clock time (i.e., AM, PM, or 24-hour clock). From study
    inception, specify the manner in which time will be collected. If a twelve hour clock is used,
    then AM or PM must be designated.
   End Date – Record the calendar date the participant/subject was prescribed to stop taking
    study drug.
   End Time – Record the clock time the participant/subject was prescribed to stop taking
    study drug. Also record the unit for clock time (i.e., AM, PM, or 24-hour clock). From study
    inception, specify the manner in which time will be collected. If a twelve hour clock is used,
    then AM or PM must be designated.
   Dose Amount – Record the dose of study drug the participant/subject was prescribed to
    take.
   Dose Unit – Record the unit for dose of study drug the participant/subject was prescribed to
    take. See the Dose Units box for abbreviations to use.
   Dose Frequency – Record the frequency participant/subject was prescribed to take the
    dose of study drug. See the Dose Frequency box for abbreviations to use.




Core Version 3.0

								
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