Study Participant Self-Administration Instructions
NOTE to study team: The instructions included on this sheet must match the dosing instructions
contained within the protocol and/or pharmacy manual. If applicable, the dosing instructions
must also match any dosing instructions found on the alert page. There must be no
discrepancies between the documents (remove this phrase from clean version of diary)
The study staff will explain how to take the study drug(s) [insert study drug name(s) here], but
these are points to remember:
Study team, please Include:
1) Frequency ( e.g. “once daily in AM”, OR “twice daily approximately 12 hours apart, etc...”)
2) Any eating, fasting and/or drinking instructions, e.g. “Take study drug on an empty stomach
with a glass of water (if there is a minimum amount of water specified in the protocol,
please include that information here). You should avoid consuming anything but water for 2
hours before and one hour after taking study drug.”
3) Any exclusionary food or beverage items, e.g., “Do not drink grapefruit juice or take
grapefruit supplements.”
4) Missed and/or vomited dose instructions are required If these doses can be made up,
explain when a dose is considered “missed” or “vomited” and provide a concrete time window,
e.g. “If you miss taking your dose at the usual time, do not take it unless it has only been an
hour since you were supposed to take it” OR “... you may take it if you remember within 6
hours” (or whatever time window is chosen). “ If you vomit a dose, do not take it again unless
you can see the capsule.”
5) Any further instructions on when to take or not to take the dose, e.g. “On days when you are
coming to the clinic, do not take your scheduled dose. Please remember to bring your study
drug supply and drug diary with you to your clinic appointment The clinic or research staff will
instruct you when to take your study drug on those days.”
6) Any storage instructions e.g. “Store all drug in the refrigerator, or at room temperature”
7) Any safety concerns, e.g. safe handling practices, child-proofing provisions (keep out of reach
of children), etc…
8) If there is more than one oral drug to be taken, please indicate if there is a specific order in
which the drugs must be taken or if there is a waiting time between taking the first and
subsequent drug(s).
Version: 1.14.2016
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9) If the particpant must take premedication prior to the study drug(s), please include those
dosing instructions.
Please call your doctor or research nurse before taking any new prescription or over-thecounter medications/supplements other than the study drugs.
For any problems, issues, or questions you may have, please contact: Enter name, title and
contact number
Study Participant Self-Administration Study Drug Diary
Please record how many capsules (or tablets) you take [(insert study drug name(s)], the time
you take them and any comments here below and bring the completed Diary as well as your
study drug supply, including empty bottles, to every study visit. This will help us keep track of
your study drug and how well you are tolerating it.
Participant Identifier:
Protocol #: enter DFCI IRB protocol number
Doctor: enter name and phone number
Nurse: enter name and phone number
Cycle Number:
Study Drug 1 Assigned Dose: enter dose mg
Study Drug 2 Assigned Dose: enter dose mg
You will take the following number of capsules/tablets each time (per dose) as listed in the table below:
Study Drug Name
# of capsules
(tablets) to take per
time/dose
# of
times/doses
each day
Approximate time to take drug
Study Drug 1
__:___
a.m.
p.m.
Study Drug 2
__:___
a.m.
p.m.
(Move and rearrange columns as you see fit for your study. Use separate columns for twice or more daily
doses. Continue on to multiple pages if necessary.)
(Black out any cells that are not applicable for this particular participant)
Day
Date
Number of
(Enter Study
Drug 1 Name,
e.g. “GDC0941”)
Capsules
(Tablets)
Version: 1.14.2016
Time of Dose
Number of
Time of Dose
(Enter Study
Drug 2 Name,
e.g. “GDC2345”)
Capsules
(Tablets)
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______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
9
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
10
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
______:______ □ a.m. / □ p.m.
□ Dose Not Taken
Why:________________________
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Participant/Caregiver Signature: _______________________________
Date:_______________
Version: 1.14.2016
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FOR STUDY TEAM USE ONLY
Staff Initials:
Date Dispensed:
# pills/caps/tabs dispensed:
Date Returned:
# pills/caps/tabs returned:
# pills/caps/tabs that should have been taken:
Discrepancy Notes:
Version: 1.14.2016
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