DATCNSNT

Table Description: Documentation of Screening DaTscan Imaging Consent

Detailed notes for this table are included below.

View Source CRFs

2.0 CRFs: Click on any PAG_NAME link below to be taken to a screenshot of how this eCRF is currently implemented in the PPMI 2.0 Study.

2.0 Data Dictionary

Table Constraints: PATNO, VISIT_ID

ITM_NAME

DSCR

ITM_TYPE

DATCNSTDISC

Informed consent was discussed with participant and/or legally authorized representative for the screening DaTscan imaging scan for PPMI 2.0 Clinical study.

BOOLEAN

DATCNSTFORM

Consent form was provided to the participant and/or legally authorized representative for review.

BOOLEAN

DATCNSTTIME

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

DATSIGNCNST

Participant and/or legally authorized representative signed and dated the informed consent.

BOOLEAN

DATCNSTCOPY

Copy of the consent form was provided to the participant and/or legally authorized representative upon conclusion of the consent process.

BOOLEAN

DATCNSTPRIR

Consent has been signed prior to any study procedures being performed.

BOOLEAN

DATCNSTAUTH

Informed consent obtained by person authorized on site delegation log.

BOOLEAN

DATCNSTQA

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

DATCNSTAUTH

0

No

DATCNSTAUTH

1

Yes

DATCNSTCOPY

0

No

DATCNSTCOPY

1

Yes

DATCNSTDISC

0

No

DATCNSTDISC

1

Yes

DATCNSTFORM

0

No

DATCNSTFORM

1

Yes

DATCNSTPRIR

0

No

DATCNSTPRIR

1

Yes

DATCNSTQA

0

No

DATCNSTQA

1

Yes

DATCNSTTIME

0

No

DATCNSTTIME

1

Yes

DATSIGNCNST

0

No

DATSIGNCNST

1

Yes

Details

The DATCNSNT table collects information captured through the Documentation of Screening DaTscan Consent form. This form is specific to consent for the screening DaTscan imagining scan. This form is only given to participants in the Prodromal Cohort, and occurs at their Screening visit. Participants in the Prodromal cohort fill out the CONSENT CRF at their Baseline visit.