ICFLOG

Table Description:

Detailed notes for this table are included below.

1.0 Description: Informed Consents Log

View Source CRFs

1.0 CRFs: Click on any PAG_NAME link below to be taken to the CRF used in the PPMI 1.0 Study.

• ICFLOG

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:

Missing Columns

ITM_NAME	DSCR_1.0
AMENDNOC	Amendment Number (char)
CNTBRTS	Consent to contact by Brain/Tissue Bank
CNTVER	Consent to contact by Verily Study team
CONSNTDT	Informed consent date
DNASHR	Consent to share DNA/RNA
DTASMSHR	Consent to share data/samples
FNDSHR	Agree to share contact info for FOUND
FUTCNTCT	Consent for future contact
ICFAPPDT	Date consent approved by IRB
ICFEND	End of Study ICF
ICFIAMND	ICF Amendment
ICFINIT	Participant initial ICF
ICFPAMND	Protocol Amendment
ICFPRTCH	Participant initiated changes
ICFPRVIS	ICF completed per visit
ICFSXFR	Reconsented due to site transfer
IRBAPPDT	Date consent approved by IRB
SEQNO	Sequence Number

Details

This form is required at Screening (and Baseline visits for Prodromal participants) and Transition visits and is available As Needed at all visits. It was introduced late in the PPMI 1.0 study and has been redesigned in 2.0 to remove no longer relevant options and to simplify workflow.

Initial Consent

This form must be completed after completing the PPMI 2.0 Documentation of Informed Consent. The Reason for Consent ICFRSN will be “Initial Consent” (option 1). In PPMI 1.0 this reason was captured in a separate variable ICFINIT.

Protocol Ammendments

This form is also completed as participats are added to new versions of a protocol. The Reason for Consent ICFRSN will be “Re-consent” (option 2). In PPMI 1.0 this reason was captured in a separate variable ICFPAMND. The name/version of the amendment will be recorded in the associated comment field ICFRSNCM

Site Transfer

This form is also completed when participants are transferred from one site to another. The Reason for Consent ICFRSN will be “Transfer from another site” (option 3). In PPMI 1.0 this reason was captured in a separate variable ICFSXFR.

Research Proxy Designation

In PPMI 2.0, this form is completed when a research proxy is assigned; see RAD for details. This was not done in PPMI 1.0. The Reason for Consent ICFRSN will be “LAR/Research Proxy consented” (option 4).

Optional Consents

In PPMI 1.0 this section included CNTVER, DNASHR, DTASMSHR, FUTCNTCT, FNDSHR and CNTBRTS. In PPMI 2.0 consent is optionally collected for RECNTDATA, RECNTRSCH, FNDSHR, and CNTBRTS.

• Contact about future research is captured in both 1.0 and 2.0 in FUTCNTCT and RECNTRSCH; these variables may be combined if it is determined that they do capture equivalent information.

• Questions about sharing data and samples are asked in DNASHR and DTASMSHR in PPMI 1.0 and in RECNTDATA in PPMI 2.0 but in 2.0 the question specifically asks about re-contact about these data rather than their general use. The equivalence of these questions will be determined in a future state.

• FNDSHR and CNTBRTS are asked in both PPMI 1.0 and 2.0. The DIFF_REASON on the options for these variables is DESIGN because the options have not changed between PPMI 1.0 and 2.0 (with the exception of the addition of the “Not Applicable” to both); but in 1.0 these options were missing from the code book.