SKBIO

Table Description:

Detailed notes for this table are included below.

1.0 Description: Skin Biopsy

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.

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:

2.0 Code Book

ITM_NAME

CODE

DECODE_1.0

ANSTHADM

0

No

ANSTHADM

1

Yes

BIOCMPLC

0

No

BIOCMPLC

1

Yes

SKBIOCMP

0

No

SKBIOCMP

1

Yes

SKBIOLOC

1

upper arm

SKBIOLOC

2

lower arm

SKBIOLOC

3

upper leg

SKBIOLOC

4

lower leg

SKBIOLOC

5

other (specify)

SKBIOSID

1

Right

SKBIOSID

2

Left

WOUNDCLS

1

dressing only

WOUNDCLS

2

steri strips

WOUNDCLS

3

suture

WOUNDCLS

4

other, specify

Missing Columns

ITM_NAME

DSCR_1.0

ANSTHADM

Was anesthesia administered

BIOCMPLC

Complications during the biopsy

BIOCOLTM

Time biopsy collected

BIOFRGTM

Time biopsy specimen was refrigerated

COMM

Comments

SBIOLCCM

Location of biopsy - other, specify

SHIPDT

Date shipped

SKBIOCMP

Was biopsy completed

SKBIOLOC

Location of skin biopsy

SKBIOSID

Which side of body was biopsy performed

WNDCLSCM

Other wound closure, specify

WOUNDCLS

Type of wound closure

Details

Amendment Two

As of February 2021, significant changes were made to the SKBIO table to account for Amendment 2. The original SKBIO CRF had questions that were non-specific about the type of Skin Biopsy, because only a formalin-fixed biopsy type was allowed. As of Amendment 2, formalin-fixed and fresh skin biopsies are both allowed, so new questions have been added that are type-specific.

Because the previous variables in the early version of this form are equivalent to the formalin-fixed variables of the amendment 2 version, there was a mapping done so that old variables can be harmonized with the new variables. See the table below for more description about how the old and new variables relate.

Previous ITM_NAME

Previous Item Description

New ITM_NAME

New Item Description

SKBIOCMP

Was skin biopsy collected?

FIXSPEC

Was a formalin-fixed specimen collected

SKBIOSID

On which side of the body was the cervical paravertebral biopsy performed?

FIXSKBSID

Which side of body was the formalin-fixed skin biopsy performed on

WOUNDCLS

What type of wound closure was used?

FIXWNDCLS

Type of wound closure used for formalin-fixed skin biopsy

WNDCLSCM

If other, please specify

FIXWNDCLSCM

Other wound closure for formalin-fixed skin biopsy, specify

BIOCOLTM

Time that biopsy was collected

FIXCOLTM

Time formalin-fixed skin biopsy collected

SKBIOCMP will be used to derive FIXSPEC.