SKBIO

Table Description: Skin Biopsy

Detailed notes for this table are included below.

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: PATNO, VISIT_ID

ITM_NAME

DSCR

ITM_TYPE

ITM_TYPE_1.0

SKBIOCMP

Was biopsy completed

BOOLEAN

CHAR

NOSKBIOCMP

Reason skin biopsy not completed

NUMBER

NOSKBIOCMPCM

Skin biopsy attempted unsuccessfully or not completed for other reason comment

TEXT

ANSTHADM

Was anesthesia administered

NUMBER

CHAR

ANSTHADMCM

Anesthesia not administered comment

TEXT

FIXSPEC

Was a formalin-fixed specimen collected

BOOLEAN

FIXSKBSID

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

NUMBER

FIXWNDCLS

Type of wound closure used for formalin-fixed skin biopsy

NUMBER

FIXWNDCLSCM

Other wound closure for formalin-fixed skin biopsy, specify

TEXT

FIXCOLTM

Time formalin-fixed skin biopsy collected

TIME

BIOFIXTM

Time biopsy specimen placed in formalin fixation

TIME

BIOFIXLOT

Formalin lot number

TEXT

FRZSPEC

Was a frozen specimen collected

BOOLEAN

FRZSKBSID

Which side of body was the frozen skin biopsy performed on

NUMBER

FRZWNDCLS

Type of wound closure used for frozen skin biopsy

NUMBER

FRZWNDCLSCM

Other wound closure for frozen skin biopsy, specify

TEXT

FRZCOLTM

Time frozen skin biopsy collected

TIME

BIOFRZTM

Time biopsy specimen frozen

TIME

BIOFRZTMP

Frozen/Freezer Temperature (Celsius)

NUMBER

2.0 Code Book

ITM_NAME

CODE

DECODE_2.0

DECODE_1.0

ANSTHADM

0

No

No

ANSTHADM

1

Yes

Yes

ANSTHADM

2

Other anesthetic

FIXSKBSID

1

Right

FIXSKBSID

2

Left

FIXSPEC

0

No

FIXSPEC

1

Yes

FIXWNDCLS

1

Dressing only

FIXWNDCLS

2

Steri strips

FIXWNDCLS

3

Suture

FIXWNDCLS

4

Other

FRZSKBSID

1

Right

FRZSKBSID

2

Left

FRZSPEC

0

No

FRZSPEC

1

Yes

FRZWNDCLS

1

Dressing only

FRZWNDCLS

2

Steri strips

FRZWNDCLS

3

Suture

FRZWNDCLS

4

Other

NOSKBIOCMP

1

Participant declined biopsy

NOSKBIOCMP

2

Procedure attempted unsuccessfully

NOSKBIOCMP

3

Other

SKBIOCMP

0

No

No

SKBIOCMP

1

Yes

Yes

Missing Columns

ITM_NAME

DSCR_1.0

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

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 frozen 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.