IMPERIAL CRS

P255-501_Headache Diary User Guide_V1_03SEP2020

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The ROAR Study HEADACHE DIARY USER GUIDE P255-501_Headache Diary User Guide_V1_03SEP2020 The headache diary is to be used by you and your child to record headaches experienced during the study, starting with the day of their first visit in the study. If your child is too young to reliably complete the diary, a parent/caregiver should assist by asking questions about their symptoms and recording their answers in the diary for them. Whenever possible, it is best if the child provides the answers to each question; however, if they are unable to describe their symptoms, record what you observe. For example, if your child asks for the lights to be turned off, they may be experiencing sensitivity to light. The diary is split into two parts. The first part, the Headache Log, is to be completed every day. The second part, Headache Details, is to be completed when a headache occurs. The diaries should be returned to the study site at every visit. You will be given new diaries to complete at each visit. It is very important that these guidelines are followed carefully to ensure that complete and accurate information is collected for the study. Headache Log The log should be completed every day. Make it part of your child's bedtime routine so that you don't forget. On each day, enter the date and mark "yes" if at least one headache was experienced. Mark "no" if no headaches occurred. If "yes" is marked, indicate how many headaches were experienced that day. For each headache experienced, complete the Headache Details section (example is below) for symptoms and any medications taken to treat the headache in the Headache Details. If the same headache continues for multiple days, answer "yes" for each day that the headache occurred; however, enter the details on only one line. Below is an example of the Headache Log completed for one week: Week Number Subject Number Date (MM/DD/YYYY) Were any headaches experienced? Number of headaches / / Yes No / / Yes No / / Yes No / / Yes No / / Yes No / / Yes No / / Yes No 07 08 2020 07 07 2020 07 09 2020 07 10 2020 07 11 2020 07 12 2020 07 13 2020 X X X X X X X 5 135 243 1 1 1

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