AVCNSNT¶
Table Description: Early Imaging Documentation of Informed 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 |
|---|---|---|
AVCNSTDISC |
Informed consent was discussed with participant and/or legally authorized representative for the PPMI 2.0 Early 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 |
|---|---|---|
AVCNSTDISC |
0 |
No |
AVCNSTDISC |
1 |
Yes |
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 |
Details¶
The AVCNSNT CRF captures consent information obtained through the Early Imaging Documentation of Informed Consent. This consent CRF is specific for the Early Imaging Sub-Study. Both 1.0 Early Imaging transition participants and new 2.0 Early Imaging participants fill out this form. For transition participants, it is filled out at a transition activity (the transition activity is the first 2.0 visit for a 1.0 participant that is transitioning into the 2.0 study). For new 2.0 Early Imaging participants, this form (along with the standard CONSENT CRF) is filled out at the Screening visit.