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Meal And Smed Modules Part Two
1. #2- Date: 19-Dec-03
MEAL SCHEDULE
WAS THE MEAL START TIME WAS THE MEAL
MEAL ADMINISTERED?
DATE OF MEAL COMPLETED?
STOP TIME (MARK ONE)
(MARK ONE)
24 HR. CLOCK
H H M M
0 NO 1 YES 24 HR. CLOCK
0 NO 1 YES
D D M M M Y Y
H H M M
MEAL SCHEDULE
WAS THE MEAL START TIME WAS THE MEAL
MEAL RELATIVE ADMINISTERED? DATE OF MEAL COMPLETED?
TIME STOP TIME
(MARK ONE) (MARK ONE)
24 HR. CLOCK
HIGH-FAT AM 0 NO 1 YES D D M M M Y Y H H M M 0 NO 1 YES
24 HR. CLOCK
H H M M
2. STUDY MEDICATION
WAS A NEW STUDY MEDICATION KIT DISPENSED? 0 NO 1 YES
KIT NUMBER DISPENSED AT THIS VISIT:
DATE AND TIME OF DOSE TAKEN AT THIS VISIT:
DATE TIME NUMBER TAKEN PER BOTTLE
SMEDDISP006
24 HR. CLOCK BOTTLE A BOTTLE B
D D M M M Y Y H H M M
3. OTHER TREATMENT
IS THE SUBJECT IN DOSE GROUP 2? 0 NO 1 YES IF YES, COMPLETE BELOW
TREATMENT WAS DOSE ADMINISTERED? DATE OF DOSE TIME OF DOSE
24 HR. CLOCK
RITONAVIR 200 mg 0 NO 1 YES
D D M M M Y Y H H M M
4. DOSING - DAY 1
START DATE OF INFUSION START TIME OF INFUSION STOP DATE OF INFUSION STOP TIME OF INFUSION
24 HR. CLOCK 24 HR. CLOCK
D D M M M Y Y H H M M D D M M M Y Y H H M M
D WEIGHT OF
A
TOTAL DOSE DELIVERED INFUSATE DELIVERED
Y
1 mg g
SITE OF INFUSION:
1 LEFT ARM 2 RIGHT ARM
3 CENTRAL LINE 98 OTHER (SPECIFY)
DOSING CHANGES
S
NO
YE
REASON SPECIFY
0 1
WAS DOSE OMITTED?
D
A
Y WAS THE INFUSION TEMPORARILY INTERRUPTED?
INTERRUPTION DURATION:
1
1 MIN 2 HR
DOSE OMITTED REASONS
9 = DELAYED HEMATOLOGIC RECOVERY
12 = DELAYED NON-HEMATOLOGIC RECOVERY (SPECIFY)
98 = OTHER (SPECIFY)
INFUSION INTERRUPTED REASONS
8 = HYPERSENSITIVITY REACTION
17 = ADVERSE EVENT (SPECIFY)
98 = OTHER (SPECIFY)
5. RECORD OF STUDY MEDICATION
WAS THE DOSE ADMINISTERED? 0 NO 1 YES
TREATMENT DATE OF DOSE TIME OF DOSE
24 HR. CLOCK
A B C
D D M M M Y Y H H M M
6. RECORD OF STUDY MEDICATION
WAS THE DOSE ADMINISTERED? 0 NO 1 YES
DOSE GROUP DATE OF DOSE TIME OF DOSE
(MARK ONE)
24 HR. CLOCK
1 2 3
4 5 6 D D M M M Y Y H H M M
7. RECORD OF STUDY MEDICATION
TREATMENT DATE OF DOSE TIME OF DOSE
24 HR. CLOCK
BMS-298585 10 mg
D D M M M Y Y H H M M
RECORD OF STUDY MEDICATION
WAS THE DOSE ADMINISTERED? 0 NO 1 YES
TREATMENT DATE OF DOSE TIME OF DOSE
24 HR. CLOCK
D D M M M Y Y H H M M
RECORD OF STUDY MEDICATION
WAS THE DOSE ADMINISTERED? DATE OF DOSE TIME OF DOSE
24 HR. CLOCK
0 NO 1 YES
D D M M M Y Y H H M M
8. DRUG ADMINISTRATION
WAS THE DOSE ADMINISTERED? 0 NO 1 YES
START TIME STOP TIME
TREATMENT DATE ADMINISTERED?
OF INFUSION OF INFUSION
24 HR. CLOCK 24 HR. CLOCK
A B
D D M M M Y Y H H M M H H M M
WAS FULL INFUSION COMPLETED? 0 NO 1 YES
TOTAL DOSE ADMINISTERED? mg