SURE-PD3

1 6 6 CONCOMITANT MEDICATION LOG 8 2

SUBJECT ID INITIALS SITE NO

Enter all medications taken during 30 days prior to the SC2 Visit. At subsequent visits record new meds, and changes/discontinuation of previously listed meds. Changes in total daily dose or route require a new line.
Row: enter 1, 2, 3, etc. Medication: Record generic name; if unknown, enter brand name. For multiple ingredient medications, indicate strength if possible, e.g., carbidopa/levodopa 25/100. Note if extended release
(e.g., CR) under Medication name. Dose: Record dose for each administration. Date: Please specify if the Start and Stop dates are ACTUAL or ESTIMATED. If the exact date is unknown, please enter your best
reasonable estimate of the date and specify which part(s) are estimated. Ongoing: Answer yes if medication is still being taken at end of study. Indication: Reason for use, not drug category.

3 = Mon/Day Est (MD)

3 = Mon/Day Est (MD)

4 = Month Est. (MON)

4 = Month Est. (MON)

ROUTE

Total Daily Dosage of

AE? 0 = No, 1 = Yes
CORRESPONDING
2 = Day Est. (DAY)

2 = Day Est. (DAY)

FREQUENCY

1 = Actual (ACT)

1 = Actual (ACT)
START STOP

0 = No, 1 = Yes
Row #

6 = Sublingual
MEDICATION

(e.g., qd, BID,

(e.g., mg, cc,
(e.g., 1, DOSE DATE DATE INDICATION

7 = Inhaled
8 = Topical

ONGOING
(List generic name, if possible)

PD MED?
2, etc.)

9 = Other
ml, puffs)
(MM/DD/YYYY) (MM/DD/YYYY)

PD Med*
UNITS

qid, etc.)

1 = Yes
3 = PO
4 = SC
5 = PR

0 = No
2 = IM
1 = IV
carbidopa/levodopa
SAMPLE 0 2 tabs qid 3 4/30/2001 2 10/31/2003 2 0 Parkinson’s disease 0 1 800
25/100 CR

*For combination PD meds, enter the total daily dosage of levodopa only.

Copyright © 2002 University of Rochester. All Rights Reserved. (10/22/08) TSO 3/30/16 Page ___ of ___
 SURE-PD3
1 6 6 ADVERSE EVENT LOG 8 6

SUBJECT ID INITIALS SITE NO

Record all adverse events that occur from signing consent to conclusion of study participation. Record disease entity as AE only if it worsens beyond what investigator expects is within normal range of fluctuation for
this subject. Elicit adverse event data by asking an open-ended question, e.g., “What unusual symptoms or medical problems have you experienced since the last visit?” Record any new or change in ongoing sign
or symptom as well as any event that has resolved since last evaluation. Enter each change in “severity” on new line. Date: Please specify if the Start and Stop dates are ACTUAL or ESTIMATED. If the exact date is
unknown, please enter your best reasonable estimate of the date and specify which part(s) are estimated. IF EVENT IS A SERIOUS ADVERSE EVENT, please refer to the Manual of Procedures for reporting guidance.

Check box if this event resulted in

Complete when resolved or at Final Visit
Relationship to Action
Relationship

withdrawal from the study

Severity SAE Study Taken with Study
to DaTscan
Drug Drug AE Status
Primary Outcome
at Final Visit
If SAE,
AE # Adverse Event START STOP date site

1 = Yes (If Yes, call NCRI)

3 = Mon/Day Est (MD)

3 = Mon/Day Est (MD)

4 = Month Est. (MON)

4 = Month Est. (MON)

(e.g., 1, (Record diagnosis if DATE 2 = Day Est. (DAY)
DATE became

2 = Day Est. (DAY)

2, etc.) known) (MM/DD/YYYY) (MM/DD/YYYY) aware

0 = not applicable

0 = not applicable

7= not yet recovered

2 = under treatment/
4 = rechallenged
1 = Actual (ACT)

1 = Actual (ACT)

discontinued
5 = permanently
(MM/DD/YYYY) If unresolved,

3 = suspended

3 = change in AE
2 = moderate

1 = unrelated

1 = unrelated
is follow-up

4 = probable
3 = possible

2 = reduced

1 = recovered

characteristic
2 = unlikely

4 = sequelae
5 = definite

6 = unknown
2 = related
3 = severe
required?

observation
1 = none
1 = mild
0 = No

5 = fatal
0 = No
1 = Yes

INVESTIGATOR’S SIGNATURE DATE STAFF CODE

Copyright © 2002 University of Rochester. All Rights Reserved. (12/9/10) TSO 3/30/16 Page ___ of ___
 ADVERSE EVENT

PRIMARY OUTCOME DEFINITIONS

1 = Recovered

2 = Under treatment/observation - currently receiving treatment for AE or currently under observation (follow-up in person, by phone,
email, etc.)

3 = Change in AE characteristic - Event has changed with regard to severity, action taken or other characteristics.
If nature of AE has changed, an additional entry should be recorded with the change noted.

4 = Sequelae - primary event has resulted in a secondary condition. e.g. broken leg resulting in a limp.

5 = Fatal - death

6 = Unknown - lost to follow-up

7 = Not yet recovered - event was ongoing at the time of the report

Copyright © 2002 University of Rochester. All Rights Reserved. (12/9/10) TSO 3/30/16
 SURE-PD3
1 6 6 DOSE MANAGEMENT LOG 9 0

SUBJECT ID

INITIALS SITE NO

THIS LOG IS TO BE USED TO RECORD THE INITIAL DOSE, TITRATIONS AND INVESTIGATOR
INITIATED DOSE CHANGES THAT OCCUR THROUGHOUT THE STUDY. Each change must be
recorded on a separate line. Do not record doses missed due to subject non-compliance as this
information will be captured on the Study Drug Dispensing/Return Log.

Reason Dosage Changed

Total Daily Dosage

A = Dosage titration (per protocol)

B = End of Dosing Period
1 = unplanned dose reduction*
Dose Frequency
(caps/day)

2 = unplanned rechallenge*
0 = no dosing 3 = unplanned temporary suspension*
1 = qd dosing 4 = permanent study drug
2 = bid dosing discontinuation*
3 = tid dosing Start Date Stop Date
(MM/DD/YYYY) (MM/DD/YYYY) *must notify the NCRI Project Manager

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Copyright © 2003 University of Rochester. All Rights Reserved. (1/7/10)TSO 3/30/16 Page __ of __
 SURE-PD3
DOSE MANAGEMENT LOG
INSTRUCTIONS

The purpose of the form is to capture investigator initiated changes in study drug dosing. Any
dosing changes initiated by the subject are considered compliance issues and will be captured
on the Study Drug Dispensing/Return Log.

Total Daily Dosage = total current daily dosage

Dose Frequency = enter the frequency of the current dose
Start Date = date that current dose was started
Stop Date = date that current dose was stopped
Reason Dosage Changed = expected when stop date is entered and explains the reason for the
stop date

Copyright © 2003 University of Rochester. All Rights Reserved. (1/7/10)TSO 3/30/16

 SURE-PD3
1 6 6
STUDY DRUG DISPENSING/RETURN LOG 9 2

SUBJECT ID ENROLLMENT ID INITIALS SITE NO

Dispensing Dispensed
DATE DATE
Type: # Capsules By # of Capsules Returned to Comments (include missed doses)
Row # Kit # Bottle # Dispensed Returned
1 = initial Dispensed Returned INITIALS
INITIALS/ (MM/DD/YYYY)
(MM/DD/YYYY) DATE
2 = redispense

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Copyright © 2007 University of Rochester. All Rights Reserved. 6/22/16 Page ___ of ___
 SURE-PD3
1 6 6 DEBIT CARD LOG 1 0 1

SUBJECT ID

INITIALS SITE NO

THIS LOG IS TO BE USED TO RECORD THE SUBJECT’S INITIALLY ASSIGNED DEBIT CARD AND
ANY CARD CHANGES THAT OCCUR THROUGHOUT THE STUDY.
Each change must be recorded on a separate line.

Row # Card # Last 4 digits Start Date End Date

Sample 9 1234 6/1/2016 8/31/2016

Sample 13 4567 9/1/2016 11/30/2016

Sample 121 7890 12/1/2016

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