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Biospecimen Cord Blood Instrument 



Event:
Birth

Participant:
Child

Domain:
Biospecimen

Type of Document:

Data Collection Instrument

Recruitment Groups:
EH, PB, HI, PBS

Version:

3.0
Release:

MDES 3.3

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.Biospecimen Cord Blood Instrument 

TABLE OF CONTENTS

BIOSPECIMEN CORD BLOOD COLLECTION	1


Biospecimen Cord Blood Instrument 

(TIME_STAMP_1).  PROGRAMMER INSTRUCTION:
    • INSERT DATE/TIME STAMP.

CB001/(PERSON_DOB). MOTHER’S DATE OF BIRTH

DATA COLLECTOR INSTRUCTION: 
    • RECORD THE MOTHER’S DATE OF BIRTH.  THE TWO DIGIT MONTH, THE TWO DIGIT DAY, AND THE FOUR DIGIT YEAR SHOULD BE RECORDED.

MONTH:	|___|___|
	M	M
DAY:	|___|___|
	D	D
YEAR:	|___|___|___|___|
	Y	Y	Y	Y

REFUSED		-1
DON’T KNOW		-2

PROGRAMMER INSTRUCTIONS: 
    • FORMAT PERSON_DOB AS YYYYMMDD.

    • HARD EDIT: INCLUDE HARD EDIT IF MONTH IS NOT BETWEEN 01 AND 12.

    • HARD EDIT: INCLUDE HARD EDIT IF DAY IS NOT BETWEEN 01 AND 31.

    • SOFT EDIT: INCLUDE SOFT EDIT IF YEAR < 1960.

CB002/(CHILD_DOB). CHILD’S DATE OF BIRTH 

DATA COLLECTOR INSTRUCTION: 
    • RECORD THE CHILD’S DATE OF BIRTH.  THE TWO DIGIT MONTH, THE TWO DIGIT DAY, AND THE FOUR DIGIT YEAR SHOULD BE RECORDED.

MONTH:	|___|___|
	M	M
DAY:	|___|___|
	D	D
YEAR:	|___|___|___|___|
	Y	Y	Y	Y

REFUSED		-1
DON’T KNOW		-2

PROGRAMMER INSTRUCTIONS: 
    • FORMAT CHILD_DOB AS YYYYMMDD.

    • HARD EDIT: INCLUDE HARD EDIT IF MONTH IS NOT BETWEEN 01 AND 12.

    • HARD EDIT: INCLUDE HARD EDIT IF DAY IS NOT BETWEEN 01 AND 31.

    • SOFT EDIT: INCLUDE SOFT EDIT IF YEAR < 2011.

CB003/(CORD_BIRTH_HR)/(CORD_BIRTH_MIN)/(CORD_BIRTH_UNIT). TIME OF CHILD’S BIRTH: HOUR\TIME OF CHILD’S BIRTH: MINUTE\TIME OF CHILD’S BIRTH AM/PM

DATA COLLECTOR INSTRUCTION: 
    • RECORD THE TIME OF THE CHILD’S BIRTH. BE SURE TO FILL THE SPACE WITH A ZERO WHEN NECESSARY AND TO MARK THE BOX TO CHOOSE “AM” OR “PM”.  FOR EXAMPLE, IF THE CHILD WAS BORN AT 2:05 PM RECORD “02:05” AND CHOOSE “PM”. 

HOUR:	|___|___|	
	H	H
MINUTES:	|___|___|	
	M	M

AM		1 
PM		2 

REFUSED		-1
DON’T KNOW		-2

PROGRAMMER INSTRUCTIONS:
    • HARD EDIT: INCLUDE HARD EDIT IF CORD_BIRTH_HR OR CORD_BIRTH_MIN IS NOT 2 DIGITS (FILL THE SPACE WITH 0 AS NECESSARY).

    • HARD EDIT: INCLUDE HARD EDIT IF CORD_BIRTH_HR IS NOT BETWEEN 01 AND 12.


    • HARD EDIT: INCLUDE HARD EDIT IF CORD_BIRTH_MIN IS NOT BETWEEN 00 AND 59.
    • HARD EDIT: INCLUDE HARD EDIT IF DATE AND TIME IS GREATER THAN CURRENT DATE AND TIME. 

CB004/(CHILD_SEX). CHILD’S GENDER


DATA COLLECTOR INSTRUCTION: 
    • SELECT THE CHILD’S GENDER.

MALE		1
FEMALE		2
BOTH		  3
REFUSED		-1
DON’T KNOW		-2

CB005/(CORD_COLLECTION). CORD BLOOD COLLECTION STATUS

Was the cord blood collected for the NCS?

YES		1	(CORD_COLLECT_DATE)
NO 		2

CB006/(CORD_NOTCOL_COMMENT). CORD BLOOD NOT COLLECTED REASON

Please choose the one reason that best describes why the blood was not collected.

DATA COLLECTOR INSTRUCTIONS: 
    • MARK ONLY ONE REASON THAT CORD BLOOD WAS NOT COLLECTED.
  
    • CHOOSE “PARENT CHOSE TO BANK” TO INDICATE PARENTS HAVE CHOSEN TO PARTICIPATE IN A PRIVATE CORD BLOOD BANKING PROGRAM. 

    • CHOOSE “OTHER BANKING PROGRAM” TO INDICATE THAT PARENTS HAVE CHOSEN TO PARTICIPATE IN A PUBLIC CORD BLOOD BANKING PROGRAM.


PARENTS CHOSE TO BANK		1	(TIME_STAMP_2)
NEED FOR CLINICAL PURPOSES		2	(TIME_STAMP_2)
OTHER BANKING PROGRAM		3	(TIME_STAMP_2)
PARENT/GUARDIAN REFUSAL		4	(TIME_STAMP_2)
QUANTITY NOT SUFFICIENT		5	(TIME_STAMP_2)
DEFECTIVE COLLECTION EQUIPMENT		6	(TIME_STAMP_2)
NO TIME		7	(TIME_STAMP_2)
PRECIPITOUS DELIVERY		8	(TIME_STAMP_2)
STUDY STAFF NOT PRESENT AT DELIVERY		9	(TIME_STAMP_2)
NCS NOT NOTIFIED OF BIRTH IN TIME		10	(TIME_STAMP_2)
PARTICIPANT NOT IDENTIFIED PRIOR TO BIRTH		11	(TIME_STAMP_2)
OTHER		-5 








CB006A/(CORD_NOTCOL_OTH). CORD BLOOD NOT COLLECTED 

DATA COLLECTOR INSTRUCTION: IF THE CORD BLOOD WAS NOT COLLECTED FOR A REASON NOT LISTED IN THE PREVIOUS QUESTION, TYPE IN THE REASON BELOW.

SPECIFY: ________________________________________(TIME_STAMP_2)

PROGRAMMER INSTRUCTION:

    • LIMIT TEXT TO 255 CHARACTERS.

CB007/(CORD_COLLECT_DATE). DATE CORD BLOOD COLLECTED

DATA COLLECTOR INSTRUCTION: 
    • RECORD THE DATE THE CORD BLOOD WAS COLLECTED.  THE TWO DIGIT MONTH, THE TWO DIGIT DAY, AND THE FOUR DIGIT YEAR SHOULD BE RECORDED.

MONTH:	|___|___|
	M	M
DAY:	|___|___|
	D	D
YEAR:	|___|___|___|___|
	Y	Y	Y	Y

REFUSED		-1
DON’T KNOW		-2

PROGRAMMER INSTRUCTIONS: 
    • FORMAT CORD_COLLECT_DATE AS YYYYMMDD.

    • HARD EDIT: INCLUDE HARD EDIT IF MONTH IS NOT BETWEEN 01 AND 12.

    • HARD EDIT: INCLUDE HARD EDIT IF DAY IS NOT BETWEEN 01 AND 31.

    • SOFT EDIT: INCLUDE SOFT EDIT IF YEAR < 2011.

CB008/(CORD_COLLECT_HR)/(CORD_COLLECT_MIN)/(CORD_COLLECT_UNIT). TIME OF CORD BLOOD COLLECTION: HOUR\TIME OF CORD BLOOD COLLECTION: MINUTE\TIME OF CORD BLOOD COLLECTION AM/PM









DATA COLLECTOR INSTRUCTION: 
    • RECORD THE TIME OF THE CORD BLOOD COLLECTION BE SURE TO FILL THE SPACE WITH A ZERO WHEN NECESSARY AND TO CHOOSE “AM” OR “PM”.  FOR EXAMPLE, IF THE CHILD WAS BORN AT 2:05 PM RECORD “02:05” AND CHOOSE “PM”. 

HOUR:	|___|___|
	H	H
MINUTES:	|___|___|
	M	M

AM		1
PM		2
REFUSED		-1
DON’T KNOW		-2

PROGRAMMER INSTRUCTIONS:
    • HARD EDIT: INCLUDE HARD EDIT IF CORD_COLLECT_HR OR CORD_COLLECT_MIN IS NOT 2 DIGITS (FILL THE SPACE WITH 0 AS NECESSARY)

    • HARD EDIT: INCLUDE HARD EDIT IF CORD_COLLECT_HR IS NOT BETWEEN 01 AND 12.

    • HARD EDIT: INCLUDE HARD EDIT IF CORD_COLLECT_MIN IS NOT BETWEEN 00 AND 59.

    • HARD EDIT: INCLUDE HARD EDIT IF DATE AND TIME IS GREATER THAN CURRENT DATE AND TIME. 

CB009/(CORD_WHERE_COLLECT). Where was the sample collected?

DATA COLLECTOR INSTRUCTIONS: 
    • IF THE CORD BLOOD WAS COLLECTED PRIOR TO DELIVERY OF THE PLACENTA, CHOOSE “IN UTERO”.

    • IF THE CORD BLOOD WAS COLLECTED AFTER DELIVERY OF THE PLACENTA, CHOOSE “EX UTERO”.

IN UTERO		1 
EX UTERO 		2 

CB010/(CORD_DELIVERY). What type of delivery was performed?


DATA COLLECTOR INSTRUCTIONS: 
    • IF THE DELIVERY WAS A VAGINAL DELIVERY CHOOSE “VAGINAL.” 

    • IF THE DEIVERY WAS CESAREAN (C-SECTION) CHOOSE “CESAREAN.” 

VAGINAL		1 
CESAREAN 		2 

CB010A/(CORD_METHOD). What method was used to collect the cord blood?

DIRECTLY FROM CORD INTO CORD BLOOD BAG OR VACUTAINER TUBES		1	(CORD_CONTAINER)
OTHER, SPECIFY		-5

CB010B/(CORD_METHOD_OTH).  CORD BLOOD COLLECTION METHOD 

DATA COLLECTOR INSTRUCTION:
    • IF THE CORD BLOOD WAS NOT COLLECTED DIRECTLY INTO CORD BLOOD BAG OR VACUTAINER TUBES, ENTER THE COLLECTION METHOD BELOW
	SPECIFY ______________________________________
PROGRAMMER INSTRUCTION:

    • LIMIT TEXT TO 255 CHARACTERS.

CB011/(CORD_CONTAINER). In what type of container was the cord blood collected for NCS?

CORD BLOOD BAG WITH HEPARIN		1	
CORD STICK VACUTAINER TUBES		2
OTHER VACUTAINER TUBES		3

CB012/(COLLECTION_TYPE).

PROGRAMMER INSTRUCTION:
    • LOOP THROUGH COLLECTION_TYPE, SPECIMEN_ID, TUBE_STATUS FOR BOTH TUBES
        ◦ DISPLAY CORRECT COLLECTION_TYPE FOR EACH LOOP:
            ▪ IF CORD_CONTAINER = 1 OR 2, THEN COLLECTION_TYPE=1; DISPLAY “CORD BLOOD BAG”
            ▪ IF CORD_CONTAINER=3:
                • IF FIRST CYCLE OF THE LOOP, THEN COLLECTION_TYPE =2; DISPLAY “LAVENDER CAP”
                • IF SECOND CYCLE OF THE LOOP, THEN COLLECTION _TYPE =3; DISPLAY “RED CAP”

CB013/(SPECIMEN_ID) MANUAL ENTRY OF SPECIMEN_ID



DATA COLLECTOR INSTRUCTIONS:

    • RECORD THE SPECIMEN_ID PRINTED ON THE LABEL OF THE CORD BLOOD COLLECTION CONTAINER.
        ◦ FOR COLLECTION_TYPE =1 (CORD BLOOD BAG), FORMAT SHOULD BE AA#######-CB##  
        ◦ FOR COLLECTION_TYPE =2 (LAVENDAR CAP), FORMAT SHOULD BE AA#######-CL##  
        ◦ FOR COLLECTION_TYPE =3 (RED CAP), FORMAT SHOULD BE AA#######-CS##  
PROGRAMMER INSTRUCTIONS

    • DISPLAY CORRECT  COLLECTION_TYPE DESCRIPTION IN BRACKETS AND FORMAT FOR SPECIMEN_ID FOR EACH LOOP:
        ◦ IF COLLECTION_TYPE=1, DISPLAY “CORD BLOOD BAG”
        ◦ IF COLLECTION_TYPE=2, DISPLAY “LAVENDER CAP”
        ◦ IF COLLECTION_TYPE=3, DISPLAY “RED CAP”

    • HARD EDIT: INCLUDE HARD EDIT IF FORMAT IS NOT:
        ◦ AA # # # # # # #-CB## COLLECTION_TYPE = 1, CORD BLOOD BAG.
        ◦  AA # # # # # # #-CL## FOR COLLECTION_TYPE= 2, LAVENDER_CAP 
        ◦ AA # # # # # # #-CS## FOR COLLECTION_TYPE=3 RED CAP
    • IF COLLECTION_TYPE=1 GO TO TIME_STAMP_2

CB014/(TUBE_STATUS). CORD BLOOD TUBE COLLECTION STATUS:

DATA COLLECTOR INSTRUCTIONS: 
    • ENTER STATUS OF COLLECTION_TYPE.
    • SELECT “FULL DRAW” TO INDICATE THAT THE BLOOD TUBE WAS FILLED TO AT LEAST 1/2 OF THE DESIRED CAPACITY. DESIRED CAPACITY IS DEFINED AS FILLED TO THE FILL LINE INDICATED ON THE BLOOD TUBE LABEL. 
    • SELECT “SHORT DRAW” TO INDICATE THAT THE BLOOD TUBE WAS FILLED TO LESS THAN 1/2 OF THE DESIRED CAPACITY. 
    • SELECT “NO DRAW” TO INDICATE THAT THE BLOOD TUBE WAS NOT COLLECTED.
FULL DRAW		1
SHORT DRAW		2
NO DRAW		3

PROGRAMMER INSTRUCTIONS: 
    • DISPLAY CORRECT  DESCRIPTION IN BRACKETS AND FORMAT FOR SPECIMEN_ID FOR EACH LOOP:
        ◦ IF COLLECTION_TYPE=2 DISPLAY “LAVENDER CAP”
        ◦ IF COLLECTION_TYPE=3 DISPLAY “RED CAP”

CB015/(OVERALL_COMMENTS). 

DATA COLLECTOR INSTRUCTION:  DO YOU HAVE ANY COMMENTS ABOUT THE CORD BLOOD COLLECTION THAT WERE NOT ALREADY NOTED?

YES	1
NO	2	   (TIME_STAMP_2)

CB016/(OVERALL_COMMENTS_OTH).  CORD BLOOD COLLECTION COMMENTS NOT ALREADY NOTED 

DATA COLLECTOR INSTRUCTION:
    • IF THERE WERE ANY CORD BLOOD COLLECTION COMMENTS NOT ALREADY NOTED, ENTER THEM BELOW.
	SPECIFY ______________________________________
PROGRAMMER INSTRUCTION:

    • LIMIT TEXT TO 255 CHARACTERS.


(TIME_STAMP_2).  PROGRAMMER INSTRUCTION:
    • INSERT DATE/TIME STAMP.