OMB #: 0925-0593
OMB Expiration Date: 8/31/2014
Cord Blood Instrument, Phase 2g
OMB Specification
Cord Blood Instrument
Event Category: |
Time-Based |
Event: |
Birth |
Administration: |
N/A |
Instrument Target: |
Biological Mother |
Instrument Respondent: |
Data Collector |
Domain: |
Biospecimen |
Document Category: |
Sample Collection |
Method: |
Data Collector Administered |
Mode (for this instrument*): |
In-Person, CAI |
OMB Approved Modes: |
In-Person, CAI |
Estimated Administration Time: |
0 minutes |
Multiple Child/Sibling Consideration: |
Per Child |
Special Considerations: |
N/A |
Version: |
4.0 |
MDES Release: |
4.0 |
*This instrument is OMB-approved for multi-mode administration but this version of the instrument is designed for administration in this/these mode(s) only.
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Cord Blood Instrument
TABLE OF CONTENTS
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Cord Blood Instrument
WHEN PROGRAMMING INSTRUMENTS, VALIDATE FIELD LENGTHS AND TYPES AGAINST THE MDES TO ENSURE DATA COLLECTION RESPONSES DO NOT EXCEED THOSE OF THE MDES. SOME GENERAL ITEM LIMITS USED ARE AS FOLLOWS:
DATA ELEMENT FIELDS |
MAXIMUM CHARACTERS PERMITTED |
DATA TYPE |
PROGRAMMER INSTRUCTIONS |
ADDRESS AND EMAIL FIELDS |
100 |
CHARACTER |
|
UNIT AND PHONE FIELDS |
10 |
CHARACTER |
|
_OTH AND COMMENT FIELDS |
255 |
CHARACTER |
|
FIRST NAME AND LAST NAME |
30 |
CHARACTER |
|
ALL ID FIELDS |
36 |
CHARACTER |
|
ZIP CODE |
5 |
NUMERIC |
|
ZIP CODE LAST FOUR |
4 |
NUMERIC |
|
CITY |
50 |
CHARACTER |
|
DOB AND ALL OTHER DATE FIELDS (E.G., DT, DATE, ETC.) |
10 |
NUMERIC
CHARACTER
|
MM MUST EQUAL 01 TO 12 DD MUST EQUAL 01 TO 31 YYYY MUST BE BETWEEN 1900 AND CURRENT YEAR. |
TIME VARIABLES |
TWO-DIGIT HOUR AND TWO-DIGIT MINUTE, AM/PM DESIGNATION |
NUMERIC |
HOURS MUST BE BETWEEN 00 AND 12; MINUTES MUST BE BETWEEN 00 AND 59 |
Instrument Guidelines for Participant and Respondent IDs:
PRENATALLY, THE P_ID IN THE MDES HEADER IS THAT OF THE PARTICIPANT (E.G. THE NON-PREGNANT WOMAN, PREGNANT WOMAN, OR THE FATHER).
POSTNATALLY, A RESPONDENT ID WILL BE USED IN ADDITION TO THE PARTICIPANT ID BECAUSE SOMEBODY OTHER THAN THE PARTICIPANT MAY BE COMPLETING THE INTERVIEW. FOR EXAMPLE, THE PARTICIPANT MAY BE THE CHILD AND THE RESPONDENT MAY BE THE MOTHER, FATHER, OR ANOTHER CAREGIVER. THEREFORE, MDES VERSION 2.2 AND ALL FUTURE VERSIONS CONTAIN A R_P_ID (RESPONDENT PARTICIPANT ID) HEADER FIELD FOR EACH POST-BIRTH INSTRUMENT. THIS WILL ALLOW ROCs TO INDICATE WHETHER THE RESPONDENT IS SOMEBODY OTHER THAN THE PARTICIPANT ABOUT WHOM THE QUESTIONS ARE BEING ASKED.
A REMINDER:
ALL RESPONDENTS MUST BE CONSENTED AND HAVE RECORDS IN THE PERSON, PARTICIPANT, PARTICIPANT_CONSENT AND LINK_PERSON_PARTICIPANT TABLES, WHICH CAN BE PRELOADED INTO EACH INSTRUMENT. ADDITIONALLY, IN POST-BIRTH QUESTIONNAIRES WHERE THERE IS THE ABILITY TO LOOP THROUGH A SET OF QUESTIONS FOR MULTIPLE CHILDREN, IT IS IMPORTANT TO CAPTURE AND STORE THE CORRECT CHILD P_ID ALONG WITH THE LOOP INFORMATION. IN THE MDES VARIABLE LABEL/DEFINITION COLUMN, THIS IS INDICATED AS FOLLOWS: EXTERNAL IDENTIFIER: PARTICIPANT ID FOR CHILD DETAIL.
(TIME_STAMP_CBC_ST).
PROGRAMMER INSTRUCTIONS |
|
CBC03000.
(CORD_BIRTH_TIME) TIME OF CHILD'S BIRTH
|___|___|:|___|___|
H H M M
(CORD_BIRTH_TIME_UNIT) TIME OF CHILD'S BIRTH AM/PM
Label |
Code |
Go To |
AM |
1 |
|
PM |
2 |
|
PROGRAMMER INSTRUCTIONS |
|
DATA COLLECTOR INSTRUCTIONS |
|
CBC05000/(CORD_COLLECTION). CORD BLOOD COLLECTION STATUS
WAS THE CORD BLOOD COLLECTED FOR THE NCS?
Label |
Code |
Go To |
YES |
1 |
CBC08000 |
NO |
2 |
|
CBC06000/(CORD_NOTCOL_COMMENT). PLEASE CHOOSE THE PRIMARY REASON THAT BEST DESCRIBES WHY THE BLOOD WAS NOT COLLECTED.
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
PARENTS CHOSE TO BANK |
1 |
OVERALL_COMMENTS |
NEED FOR CLINICAL PURPOSES |
2 |
OVERALL_COMMENTS |
OTHER BANKING PROGRAM |
3 |
OVERALL_COMMENTS |
PARENT/GUARDIAN REFUSAL |
4 |
OVERALL_COMMENTS |
QUANTITY NOT SUFFICIENT |
5 |
OVERALL_COMMENTS |
DEFECTIVE COLLECTION EQUIPMENT |
6 |
OVERALL_COMMENTS |
NO TIME |
7 |
OVERALL_COMMENTS |
PRECIPITOUS DELIVERY |
8 |
OVERALL_COMMENTS |
STUDY STAFF NOT PRESENT AT DELIVERY |
9 |
OVERALL_COMMENTS |
NCS NOT NOTIFIED OF BIRTH IN TIME |
10 |
OVERALL_COMMENTS |
PARTICIPANT NOT IDENTIFIED PRIOR TO BIRTH |
11 |
OVERALL_COMMENTS |
OTHER |
-5 |
|
CBC07000/(CORD_NOTCOL_OTH). CORD BLOOD NOT COLLECTED
SPECIFY: ____________________________________
DATA COLLECTOR INSTRUCTIONS |
|
PROGRAMMER INSTRUCTIONS |
|
CBC08000. DATE CORD BLOOD COLLECTED
DATA COLLECTOR INSTRUCTIONS |
|
(CORD_COLLECT_MM) MONTH: |___|___|
M M
Label |
Code |
Go To |
DON'T KNOW |
-2 |
|
(CORD_COLLECT_DD) DAY: |___|___|
D D
Label |
Code |
Go To |
DON'T KNOW |
-2 |
|
(CORD_COLLECT_YYYY) YEAR: |___|___|___|___|
Y Y Y Y
Label |
Code |
Go To |
DON'T KNOW |
-2 |
|
CBC09000.
(CORD_COLLECT_TIME) TIME OF CORD BLOOD COLLECTION:
|___|___|:|___|___|
H H M M
Label |
Code |
Go To |
DON'T KNOW |
-2 |
CORD_WHERE_COLLECT |
(CORD_COLLECT_TIME_UNIT) TIME OF CORD BLOOD COLLECTION: AM/PM
Label |
Code |
Go To |
AM |
1 |
|
PM |
2 |
|
DATA COLLECTOR INSTRUCTIONS |
|
CBC10000/(CORD_WHERE_COLLECT). WHERE WAS THE SAMPLE COLLECTED?
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
IN UTERO |
1 |
|
EX UTERO |
2 |
|
DON'T KNOW |
-2 |
|
CBC11000/(CORD_DELIVERY). WHAT TYPE OF DELIVERY WAS PERFORMED?
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
VAGINAL |
1 |
|
CESAREAN |
2 |
|
DON'T KNOW |
-2 |
|
CBC13000/(CORD_METHOD). WHAT METHOD WAS USED TO COLLECT THE CORD BLOOD?
Label |
Code |
Go To |
DIRECTLY FROM CORD INTO CORD STICK VACUTAINER TUBES |
1 |
|
DIRECTLY FROM CORD INTO OTHER VACUTAINER TUBES |
2 |
|
OTHER |
-5 |
|
CBC14000/(CORD_METHOD_OTH). CORD BLOOD COLLECTION METHOD
SPECIFY: ___________________________________
DATA COLLECTOR INSTRUCTIONS |
|
CBC16000/(TUBE_STATUS). CORD BLOOD TUBE COLLECTION STATUS FOR {CORD CONTAINER}:
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
FULL DRAW |
1 |
|
SHORT DRAW |
2 |
|
NO DRAW |
3 |
|
PROGRAMMER INSTRUCTIONS |
|
CBC17000/(SPECIMEN_ID). SPECIMEN ID FOR {CORD CONTAINER}:
|___|___|___|___|___|___|___|___|___|-|___|___|___|___|
DATA COLLECTOR INSTRUCTIONS |
|
PROGRAMMER INSTRUCTIONS |
IF COLLECTION_TYPE =
1, DISPLAY "LAVENDER TOP, CL10" IN {CORD CONTAINER}
AND FORMAT AS A A # # # # # # # - CL10. IF COLLECTION_TYPE =
2, DISPLAY "RED TOP, CS10" IN {CORD CONTAINER} AND
FORMAT AS A A # # # # # # # - CS10.
|
CBC19000/(CORD_COLLECTED). WHO COLLECTED THE SPECIMEN?
Label |
Code |
Go To |
HOSPITAL STAFF |
1 |
|
NCS STAFF |
2 |
|
DON'T KNOW |
-2 |
|
CBC22000/(OVERALL_COMMENTS). DO YOU HAVE ANY COMMENTS ABOUT THE CORD BLOOD COLLECTION THAT WERE NOT ALREADY NOTED?
Label |
Code |
Go To |
YES |
1 |
|
NO |
2 |
TIME_STAMP_CBC_ET |
CBC23000/(OVERALL_COMMENTS_OTH). CORD BLOOD COLLECTION COMMENTS NOT ALREADY NOTED
SPECIFY: __________________________________________
DATA COLLECTOR INSTRUCTIONS |
|
(TIME_STAMP_CBC_ET).
PROGRAMMER INSTRUCTIONS |
|
(TIME_STAMP_BC_ST).
PROGRAMMER INSTRUCTIONS |
INSERT DATE/TIME STAMP |
BC01000/(CENTIFUGE_LOCATION). CENTRIFUGATION LOCATION
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
DEFAULT COLLECTION LOCATION |
1 |
EQUIP_ID |
SPSC |
2 |
TIME_STAMP_BC_ET |
OTHER |
-5 |
|
BC02000/(CENTRIFUGE_LOCATION_OTH). SPECIFY: ___________________________________________
BC03000/(EQUIP_ID). EQUIPMENT ID FOR CENTRIFUGE
_____________________________________
DATA COLLECTOR INSTRUCTIONS |
|
BC04000. DATE AND TIME CENTRIFUGATION BEGAN
(CENTRIFUGE_START_TIME) CENTRIFUGE START - TIME
|___|___|:|___|___|
H H M M
(CENTRIFUGE_START_TIME_UNIT) CENTRIFUGE START - AM/PM
Label |
Code |
Go To |
AM |
1 |
|
PM |
2 |
|
(CENTRIFUGE_START_MM) CENTRIFUGE START - DATE: MONTH
|___|___|
M M
(CENTRIFUGE_START_DD) CENTRIFUGE START - DATE: DAY
|___|___|
D D
(CENTRIFUGE_START_YYYY) CENTRIFUGE START - DATE: YEAR
|___|___|___|___|
Y Y Y Y
DATA COLLECTOR INSTRUCTIONS |
|
BC05000. DATE AND TIME CENTRIFUGATION ENDED
(CENTRIFUGE_END_TIME) CENTRIFUGE END - TIME
|___|___|:|___|___|
H H M M
(CENTRIFUGE_END_TIME_UNIT) CENTRIFUGE END - AM/PM
Label |
Code |
Go To |
AM |
1 |
|
PM |
2 |
|
(CENTRIFUGE_END_MM) CENTRIFUGE END - DATE: MONTH
|___|___|
M M
(CENTRIFUGE_END_DD) CENTRIFUGE END - DATE: DAY
|___|___|
D D
(CENTRIFUGE_END_YYYY) CENTRIFUGE END - DATE: YEAR
|___|___|___|___|
Y Y Y Y
DATA COLLECTOR INSTRUCTIONS |
|
BC06000/(CENTRIFUGE_TEMP_MEASURE). TEMPERATURE OF CENTRIFUGE
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
TEMPERATURE |
1 |
BC08000 |
NOT ABLE TO MEASURE - THERMOMETER BROKEN |
2 |
BLOOD_HEMOLYZE |
NOT ABLE TO MEASURE - THERMOMETER NOT AVAILABLE |
3 |
BLOOD_HEMOLYZE |
NOT ABLE TO MEASURE - OTHER |
-5 |
|
BC07000/(CENTRIFUGE_TEMP_MEASURE_OTH). SPECIFY: __________________________________
PROGRAMMER INSTRUCTIONS |
|
BC08000. TEMPERATURE OF CENTRIFUGE
DATA COLLECTOR INSTRUCTIONS |
|
(CENTRIFUGE_TEMP) RECORD THE TEMPERATURE TO THE FIRST DECIMAL POINT.
|___|___|.|___|°C
PROGRAMMER INSTRUCTIONS |
|
(CENTRIFUGE_TEMP_POSNEG) RECORD IF THE TEMPERATURE IS A POSITIVE OR NEGATIVE VALUE.
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
POSITIVE |
1 |
|
NEGATIVE |
2 |
|
BC09000/(BLOOD_HEMOLYZE). DID BLOOD HEMOLYZE?
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
YES, THE TUBE HEMOLYZED |
1 |
|
NO, THE TUBE DID NOT HEMOLYZE |
2 |
|
BC10000/(CENTRIFUGE_COMMENT). CENTRIFUGE OTHER COMMENTS
Label |
Code |
Go To |
NO COMMENTS |
1 |
TIME_STAMP_BC_ET |
COMMENT |
2 |
|
BC11000/(CENTRIFUGE_COMMENT_OTH). SPECIFY: ______________________________________
DATA COLLECTOR INSTRUCTIONS |
|
(TIME_STAMP_BC_ET).
PROGRAMMER INSTRUCTIONS |
INSERT DATE/TIME STAMP |
(TIME_STAMP_PFC_ST).
PROGRAMMER INSTRUCTIONS |
INSERT DATE/TIME STAMP |
PFC01000/(COLD_TEMP_MEASURE). TEMPERATURE OF REFRIGERATED CHAMBER
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
TEMPERATURE |
1 |
PFC03000 |
NOT ABLE TO MEASURE - THERMOMETER BROKEN |
2 |
COLD_THRESHOLD_LOW |
NOT ABLE TO MEASURE - THERMOMETER NOT AVAILABLE |
3 |
COLD_THRESHOLD_LOW |
NOT ABLE TO MEASURE - OTHER |
-5 |
|
NOT APPLICABLE |
-7 |
COLD_THRESHOLD_LOW |
PFC02000/(COLD_TEMP_MEASURE_OTH). SPECIFY: _______________________________________
PROGRAMMER INSTRUCTIONS |
|
PFC03000. RECORD TEMPERATURE OF REFRIGERATED CHAMBER
DATA COLLECTOR INSTRUCTIONS |
|
(COLD_TEMP) ENTER TEMPERATURE IN DEGREES CELSIUS
|___|___|.|___|°C
PROGRAMMER INSTRUCTIONS |
|
(COLD_TEMP_POSNEG) RECORD IF THE TEMPERATURE IS A POSITIVE OR NEGATIVE VALUE
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
POSITIVE |
1 |
|
NEGATIVE |
2 |
|
PFC04000/(COLD_THRESHOLD_LOW). STATUS OF REFRIGERATED CHAMBER LOW THRESHOLD MONITOR
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
YES, IN CHAMBER |
1 |
|
NO, NOT REQUIRED |
2 |
|
NO, NOT AVAILABLE |
3 |
|
PFC05000/(COLD_THRESHOLD_HIGH). STATUS OF REFRIGERATED CHAMBER UPPER THRESHOLD MONITOR
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
YES, IN CHAMBER |
1 |
|
NO, NOT REQUIRED |
2 |
|
NO, NOT AVAILABLE |
3 |
|
PFC06000/(TRANSPORT_COMMENT). TRANSPORT COMMENT
Label |
Code |
Go To |
NO COMMENTS |
1 |
TIME_STAMP_PFC_ET |
COMMENT |
2 |
|
PFC07000/(TRANSPORT_COMMENT_OTH). _______________________________________________
DATA COLLECTOR INSTRUCTIONS |
|
(TIME_STAMP_PFC_ET).
PROGRAMMER INSTRUCTIONS |
INSERT DATE/TIME STAMP |
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
File Modified | 0000-00-00 |
File Created | 2021-01-28 |