CONSENT¶
Table Description: 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 |
|---|---|---|
CNSTDISC |
Informed consent was discussed with participant and/or legally authorized representative for the PPMI 2.0 Clinical 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 |
CNSTDISC |
0 |
No |
CNSTDISC |
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¶
In PPMI 2.0, the CONSENT table has been added to explicitly capture the Documentation of Informed Consent form. The form is a series of true/false questions that detail the informed consent process for each participant. It is an investigator completed assessment. In PPMI 1.0, the consent process was captured in the Written Informed Consent form, but the answers to the individual questions were not recorded in the same explicit way.
SOA and Cohorts
The timing of when the CONSENT form is completed varies depending on cohort. For participants in the Healthy Control, Parkinson’s Disease, or PD Genetic Cohorts, the CONSENT CRF is completed at Screening and at any Transition Activity. A Transition Activity is the first 2.0 visit for a 1.0 participant that is transitioning into the 2.0 study. For the Prodromal Cohort, it is completed at the Baseline visit and at any Transition Activity.
Notably, transition participants from the 1.0 Early Imaging Sub-Study do not fill out this form, and instead use the Early Imaging Documentation of Informed Consent form, captured in the AVCNSNT table. This is because transitioning participants from the 1.0 Early Imaging Sub-Study are not a part of the PPMI 2.0 Study, and don’t need to fill out the PPMI 2.0 consent form. New participants for the 2.0 Early Imaging Sub-Study (those that are not transitioning from 1.0) fill out both this CONSENT form and the AVCNSNT form at their screening visit.
For any cohort, if the consent form is changed at any point throughout the study, all participants will be re-consented with the new form prior to completing any further study activities. This should be indicated in the ICFLOG table (Reason for Consent ICFRSN will be option 2, indicating re-consent).
SIGNCNST
The SIGNCNST variable is the only variable in the CONSENT table that existed in PPMI 1.0. However, the variable previously existed in the SCREEN table in 1.0.