ICFLOG¶

Table Description: Informed Consent Tracking Log

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.

ICFLOG

2.0 Data Dictionary¶

Table Constraints: PATNO, SEQNO

ITM_NAME	DSCR	ITM_TYPE	DSCR_1.0	ITM_TYPE_1.0
SEQNO	Sequence Number	NUMBER	Sequence Number	NUMBER
STUDYVDT	Study template version date	DATE
SITEVDT	Site version date	DATE
IRBAPPDT	Site IRB approval date	DATE	Date consent approved by IRB	DATE
ICFAPPDT	Date ICF signed	DATE	Date consent approved by IRB	DATE
ICFPRTCL	Select Protocol for Consent	NUMBER
ICFRSN	Reason for Consent	NUMBER
ICFRSNCM	Reason for reconsent comment	TEXT
FNDSHR	Consent to share contact info with FOUND	BOOLEAN	Agree to share contact info for FOUND	CHAR
CNTBRTS	Consent to share contact info with Pathology Core	NUMBER	Consent to contact by Brain/Tissue Bank	CHAR
RECNTDATA	Consent to re-contact for use of data or samples	BOOLEAN
RECNTRSCH	Consent to re-contact for other research	BOOLEAN

2.0 Code Book¶

ITM_NAME	CODE	DECODE_2.0
CNTBRTS	0	No
CNTBRTS	1	Yes
CNTBRTS	2	Not Applicable
FNDSHR	0	No
FNDSHR	1	Yes
ICFPRTCL	1	002 Clinical
ICFPRTCL	2	004 Early Imaging
ICFPRTCL	3	008 Tau PET Imaging
ICFRSN	1	Initial Consent
ICFRSN	2	Re-consent
ICFRSN	3	Transfer from another site
ICFRSN	4	LAR/Research Proxy consented
RECNTDATA	0	No
RECNTDATA	1	Yes
RECNTRSCH	0	No
RECNTRSCH	1	Yes

Missing Columns¶

ITM_NAME	DSCR_1.0
AMENDNOC	Amendment Number (char)
CNTVER	Consent to contact by Verily Study team
CONSNTDT	Informed consent date
DNASHR	Consent to share DNA/RNA
DTASMSHR	Consent to share data/samples
FUTCNTCT	Consent for future contact
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

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” option to CNTBRTS); but in 1.0 these options were missing from the code book.