Study Drug Diary Template One Drug

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					STUDY DRUG DIARY TEMPLATE (One Drug) - Modify the diary to meet the specific needs of the study. Remember to delete all instructions, i.e., blue
text - these statements are provided for guidance only.


OTHER MEDICATIONS TAKEN                                                                                        Study Participant
                                                                                                              Self-Administration
If you take a daily medication (prescribed or otherwise), please use one                                       Study Drug Diary
line per drug and indicate the start and stop dates under the "Date(s)                                  Dana-Farber/Harvard Cancer Center
Taken" section (i.e., 6/2/09 - 6/5/09).

         Drug Name                  Dose        Dates Taken         Reason Taken               Participant Identifier: ____________________
                                                                                               Protocol # : Insert DFCI IRB protocol number
                                                                                               Your MD ____________________ Phone ____________________
                                                                                               Your RN _____________________ Phone ____________________

                                                                                               STUDY DRUG INSTRUCTIONS:

                                                                                               Study Drug: Insert drug name
                                                                                               How Much: Your dose is enter the amount and units.
                                                                                               How Often: You will take each dose ….
                                                                                               When: You should take your dose ….

                                                                                               SPECIAL INSTRUCTIONS:
Study Participant Initials __________         Date _________                                   List any special drug instructions. When appropriate, include:
                                                                                               (i) exclusionary food or beverage item; (ii) storage requirements;
                                                                                               (iii) mixing instructions; (iv) what to do with late, missed or vomited
                   FOR STUDY TEAM USE ONLY                                                     doses; (v) information related to safety concerns; and (vi) a statement
                                                                                               that drug must be kept in original container.
Staff Initials:
Date Dispensed:                               Date Returned:                                   End with a reminder to bring any unused study drug, all empty
# pills/caps/tabs dispensed:                  # pills/caps/tabs returned:                      containers, and diary to the next clinic visit.

# pills/caps/tabs that should have been taken:

Discrepancy Notes:
DOSING LOG                                                                     SYMPTOMS/SIDE EFFECTS
                             Insert study drug name
Cycle: ___                   For each AM dose take: # pills/capsules/tablets   Please record any side effects experienced during this cycle.
                             For each PM dose take: # pills/capsules/tablets   Include the date the particular symptom started and when it
                                                                               ended. Please evaluate the severity of the symptom according to
Please indicate the date, time, amount taken and any comments.                 the following scale:

                                 Amount Taken                                  Mild: Awareness of sign or symptom; easily tolerated and did
               Date          AM dose    PM dose             Comments           not affect ability to perform normal daily activities. Symptom
Ex:          6/1/2009        8 am - 1 7:30 pm - 1         vomited PM pill      did not require medication or therapeutic intervention.
Day 1
Day 2                                                                          Moderate: Significant discomfort which interfered with ability
Day 3                                                                          to perform normal daily activities. Symptom was easily resolved
Day 4                                                                          with at home medication or simple therapeutic intervention.
Day 5
Day 6                                                                          Severe: Marked discomfort with an inability to carry out
Day 7                                                                          normal daily activities. Symptom required new medication
Day 8                                                                          and/or therapeutic intervention in order to resolve.
Day 9
Day 10                                                                         Please Note: The severity should reflect the most severe level
Day 11                                                                         experienced during the time period.
Day 12
Day 13                                                                                   Symptom               Start Date End Date Severity
Day 14
Day 15
Day 16
Day 17
Day 18
Day 19
Day 20
Day 21
Day 22
Day 23
Day 24
Day 25
Day 26
Day 27
Day 28

				
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posted:6/20/2012
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