TAUCNSNT

Table Description: (Tau Substudy) Documentation of Informed Consent

Detailed notes for this table are included below.

2.0 Data Dictionary

Table Constraints: PATNO, VISIT_ID

ITM_NAME	DSCR	ITM_TYPE
TAUCNSTDISC	Informed consent was discussed with participant and/or legally authorized representative for the PPMI Tau Imaging study.	BOOLEAN
CNSTFORM	Consent form was provided to the participant and/or legally authorized representative for review.	BOOLEAN
CNSTTIME	Participant and/or legally authorized representative were given adequate time to read the consent form and discuss the study with study staff and/or person of participant’s choice.	BOOLEAN
SIGNCNST	Participant and/or legally authorized representative signed and dated the informed consent.	BOOLEAN
CNSTCOPY	Copy of the consent form was provided to the participant and/or legally authorized representative upon conclusion of the consent process.	BOOLEAN
CNSTPRIR	Consent has been signed prior to any study procedures being performed.	BOOLEAN
CNSTAUTH	Informed consent obtained by person authorized on site delegation log.	BOOLEAN
CNSTQA	During the informed consent process, the participant and/or authorized representative had the opportunity to ask questions and receive answers by study personnel.	BOOLEAN

2.0 Code Book

ITM_NAME	CODE	DECODE_2.0
CNSTAUTH	0	No
CNSTAUTH	1	Yes
CNSTCOPY	0	No
CNSTCOPY	1	Yes
CNSTFORM	0	No
CNSTFORM	1	Yes
CNSTPRIR	0	No
CNSTPRIR	1	Yes
CNSTQA	0	No
CNSTQA	1	Yes
CNSTTIME	0	No
CNSTTIME	1	Yes
SIGNCNST	0	No
SIGNCNST	1	Yes
TAUCNSTDISC	0	No
TAUCNSTDISC	1	Yes

Details

The TAUCNSNT CRF is the Tau Substudy Documentation of Informed Consent. This consent CRF is specific for the Tau Sub-Study, and is completed as needed by participants in the Prodromal, Healthy Control, PD and Early Imaging 2.0 cohorts who are enrolled in the substudy. The completion of the Tau Documentation of Informed Consent is an additional consent form on top of those required for a participant’s cohort (CONSENT, AVCNSNT).