Birth_ChildBiospecimenPickUpInstrument

Birth_ChildBiospecimenPickUpInstrument.docx

Continuation of National Children's Study Vanguard (Pilot) Study Data Collection: Study Visits through 60-Months and Sibling Birth Enrollment

Birth_ChildBiospecimenPickUpInstrument

OMB: 0925-0593

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OMB #: 0925-0593

OMB Expiration Date: 8/31/2014

Child Biospecimen Pick-Up Instrument, Phase 2g

OMB Specification


Child Biospecimen Pick-Up Instrument


Event Category:

Time-Based

Event:

Birth

Administration:

N/A

Instrument Target:

Child

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 Event

Special Considerations:

N/A

Version:

1.0

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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Child Biospecimen Pick-Up Instrument



TABLE OF CONTENTS





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Child Biospecimen Pick-Up Instrument



GENERAL PROGRAMMER INSTRUCTIONS:

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

  • Limit text to 255 characters

FIRST NAME AND LAST NAME

30

CHARACTER

  • Limit text to 30 characters

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



  • DISPLAY AS MM/DD/YYYY

  • STORE AS YYYY-MM-DD

  • HARD EDITS:

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

  • HARD EDITS:

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.





CHILD BIOSPECIMEN PICK UP


(TIME_STAMP_CBP_ST).


PROGRAMMER INSTRUCTIONS

  • INSERT DATE/TIME STAMP

  • PRELOAD PARTICIPANT ID (P_ID) FOR CHILD AND RESPONDENT ID (R_P_ID) FOR ADULT CAREGIVER.

  • PRELOAD ​STAFF_ID.


DATA COLLECTOR INSTRUCTIONS

  • COMPLETE WHEN AN NCS DATA COLLECTOR PICKS UP BIRTH BIOSPECIMENS FROM THE CHILD.

  • IF BIOSPECIMENS FROM MULTIPLE CHILDREN ARE PICKED UP AT THE SAME LOCATION IN ONE ATTEMPT, A SEPARATE INSTRUMENT MUST BE COMPLETED FOR EACH CHILD.


CBP00100/(SPECIMEN_NUM_PU). HOW MANY SPECIMENS ARE BEING PICKED UP?

 

|___|

NUMBER


PROGRAMMER INSTRUCTIONS

  • DISPLAY HARD EDIT IF SPECIMEN_NUM_PU > 5.

  • LOOP THROUGH SPECIMEN_TYPE, SPECIMEN_SAME_DATE (IF APPLICABLE), CBP01000, CBP02000, SPECIMEN_ID, SPEC_STORED, SPEC_STORAGE_COND, AND SPECIMEN_PICKUP_COND UNTIL NUMBER OF LOOPS = SPECIMEN_NUM_PU.


CBP00200/(SPECIMEN_TYPE). WHICH SPECIMEN DID YOU PICK UP?


DATA COLLECTOR INSTRUCTIONS

  • IF MORE THAN ONE SPECIMEN COLLECTED, SELECT ONE PER LOOP.


Label

Code

Go To

INFANT BLOOD SPOT CARD

1


CORD BLOOD - LAVENDER TOP TUBE

2


CORD BLOOD - RED TOP TUBE

3


PLACENTA 10

4


PLACENTA 11

5


FULL PLACENTA

6



PROGRAMMER INSTRUCTIONS

  • IF SPECIMEN_NUM_PU = 1 OR IF THIS IS THE FIRST LOOP, GO TO CBP01000.

  • OTHERWISE, GO TO SPECIMEN_SAME_DATE.


CBP00300/(SPECIMEN_SAME_DATE). DID YOU PICK UP THIS SPECIMEN AT THE SAME TIME AS {SPECIMEN_TYPE}?


Label

Code

Go To

YES

1

SPECIMEN_ID

NO

2



PROGRAMMER INSTRUCTIONS

  • PRELOAD AND DISPLAY THE SPECIMEN_TYPE FROM THE FIRST LOOP:

    • IF SPECIMEN_TYPE = 1, DISPLAY "INFANT BLOOD SPOT CARD."

    • IF SPECIMEN_TYPE = 2, DISPLAY "CORD BLOOD - LAVENDER TOP TUBE."

    • IF SPECIMEN_TYPE = 3, DISPLAY "CORD BLOOD - RED TOP TUBE."

    • IF SPECIMEN_TYPE = 4, DISPLAY "PLACENTA 10."

    • IF SPECIMEN_TYPE = 5, DISPLAY "PLACENTA 11."

    • IF SPECIMEN_TYPE ​= 6, DISPLAY "FULL PLACENTA"

  • IF SPECIMEN_SAME_DATE = 1, SET SPECIMEN_PICKUP_MM, SPECIMEN_PICKUP_DD, SPECIMEN_PICKUP_YYYY, SPECIMEN_PICKUP_TIME, AND SPECIMEN_PICKUP_TIME_UNIT = RESPONSES SELECTED FOR FIRST LOOP.


CBP01000. SPECIMEN PICK-UP DATE:


(SPECIMEN_PICKUP_MM) |___|___|

   M     M


(SPECIMEN_PICKUP_DD) |___|___|

   D    D


(SPECIMEN_PICKUP_YYYY) |2|0|___|___| 

 Y Y   Y     Y


CBP02000. SPECIMEN PICK-UP TIME:


(SPECIMEN_PICKUP_TIME) |___|___|:|___|___|

  H     H       M     M


(SPECIMEN_PICKUP_TIME_UNIT)


Label

Code

Go To

AM

1


PM

2



CBP03000/(SPECIMEN_ID). SPECIMEN ID FOR {SPECIMEN TYPE}

|__|__|__|__|__|__|__|__|__|-|__|__|__|__|


PROGRAMMER INSTRUCTIONS

  • IF SPECIMEN_TYPE = 1, DISPLAY "INFANT BLOOD SPOT CARD" AS {SPECIMEN TYPE} AND FORMAT SPECIMEN ID AS TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH HS01 (AA#######-HS01).

  • IF SPECIMEN_TYPE = 2, DISPLAY "CORD BLOOD - LAVENDER TOP TUBE" AS {SPECIMEN TYPE} AND FORMAT SPECIMEN ID AS TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH CL10 (AA#######-CL10). 

  • IF SPECIMEN_TYPE = 3, DISPLAY "CORD BLOOD - RED TOP TUBE" AS {SPECIMEN TYPE} AND FORMAT SPECIMEN ID AS TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH CS10 (AA#######-CS10). 

  • IF SPECIMEN_TYPE = 4, DISPLAY "PLACENTA" AS {SPECIMEN TYPE} AND FORMAT SPECIMEN ID AS TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH PC10 (AA#######-PC10). 

  • IF SPECIMEN_TYPE = 5, DISPLAY "PLACENTA" AS {SPECIMEN TYPE} AND FORMAT SPECIMEN ID AS TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH PC11 (AA#######-PC11). 

  • IF SPECIMEN_TYPE = 6, DISPLAY "FULL PLACENTA" AS {SPECIMEN TYPE} AND FORMAT SPECIMEN ID AS TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH PCXX (AA#######-PCXX). 


CBP04100/(SPEC_STORED). WAS THE SPECIMEN STORED BEFORE PICK-UP BY NCS STAFF?


Label

Code

Go To

YES

1


NO

2

SPECIMEN_PICKUP_COND


CBP04200/(SPEC_STORAGE_COND). IDENTIFY THE STORAGE CONDITION


Label

Code

Go To

REFRIGERAED

1


FROZEN

2


AMBIENT

3


DON'T KNOW

-2



CBP05000/(SPECIMEN_PICKUP_COND). CONDITION OF SPECIMEN UPON PICK-UP


Label

Code

Go To

PICKED UP OK

1


PICKED UP BROKEN

2


PICKED UP LEAKING

3


PICKED UP AT INCORRECT TEMPERATURE

4


MISSING SPECIMEN ID LABEL

5


SPECIMEN LOST

6


SPECIMEN NOT COLLECTED

7


NOT AVAILABLE

8


NOT APPLICABLE

-7



PROGRAMMER INSTRUCTIONS

  • IF NUMBER OF LOOPS = SPECIMEN_NUM_PU, GO TO SPECIMEN_PICKUP_COMMENTS.

  • OTHERWISE, GO TO SPECIMEN_TYPE.


CBP06000/(SPECIMEN_PICKUP_COMMENTS). DO YOU HAVE ANY COMMENTS ABOUT THE PICK-UP?


Label

Code

Go To

YES

1


NO

2

REMAINING_SPECIMEN


CBP07000/(SPECIMEN_PICKUP_COMMENTS_OTH). COMMENTS ABOUT PICK-UP: _________________________________________________________________


CBP08000/(REMAINING_SPECIMEN). ARE THERE ADDITIONAL BIOSPECIMEN SAMPLES THAT NEED TO BE PICKED UP?


Label

Code

Go To

YES

1


NO

2



PROGRAMMER INSTRUCTIONS

  • IF REMAINING_SPECIMEN = 1, SET INSTRUMENT_STATUS = 3, AND BEGIN AT CBP00100 WHEN INSTRUMENT OPENED AGAIN.
    OTHERWISE, SET INSTRUMENT_STATUS = 4, AND CLOSE OUT OF THE INSTRUMENT COMPLETELY.


(TIME_STAMP_CBP_ET).


PROGRAMMER INSTRUCTIONS

INSERT DATE/TIME STAMP


 

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