32.6 Survey

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

Birth_PlacentaInstrument

Adult-Focused Biospecimen Collection (Birth)

OMB: 0925-0593

Document [docx]
Download: docx | pdf

OMB #: 0925-0593

OMB Expiration Date: 8/31/2014

Placenta Instrument, Phase 2g

OMB Specification


Placenta 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:

2.0

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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Placenta Instrument



TABLE OF CONTENTS





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Placenta 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.





PLACENTA INSTRUMENT


(TIME_STAMP_PI_ST).


PROGRAMMER INSTRUCTIONS

  • INSERT DATE/TIME STAMP

  • PRELOAD PARTICIPANT ID (P_ID) FOR THE CHILD.


DATA COLLECTOR INSTRUCTIONS

  • IF NON-FIXED PLACENTA(S) ARE AVAILABLE FROM THE PARTICIPANT'S DELIVERY, NCS DATA COLLECTORS OR HOSPITAL STAFF WILL WEIGH AND PHOTOGRAPH THE PLACENTA AND ATTACHED UMBILICAL CORD(S).

  • A CAMERA AND SCALE AS WELL AS SUPPLIES TO DISSECT, PRESERVE, AND TRANSPORT TWO SECTIONS OF NON-FIXED PLACENTA ARE NEEDED.

  • FOLLOW THE INSTRUCTIONS IN THE NCS BIOSPECIMEN PLACENTA PROCEDURE.

  • COMPLETE THIS INSTRUMENT WITH THE BEST INFORMATION AVAILABLE.


PI02000. TIME OF CHILD'S BIRTH:


(CHILD_BIRTH_TIME) |___|___|:|___|___|

  H      H      M     M


(CHILD_BIRTH_TIME_UNIT)


Label

Code

Go To

AM

1


PM

2



PI03000. TIME OF PLACENTA DELIVERY


(PLACENTA_DELIVERY_TIME) |___|___|:|___|___|

  H     H       M    M


Label

Code

Go To

DON'T KNOW

-2

PLAC_COLLECT


(PLACENTA_DELIVERY_TIME_UNIT)


Label

Code

Go To

AM

1


PM

2



PI04000/(PLAC_COLLECT). WAS THE PLACENTA COLLECTED?


Label

Code

Go To

YES

1


NO

2



PI05000/(REASON_PLAC_NOCOLLECT). CHOOSE THE PRIMARY REASON THAT BEST DESCRIBES WHY THE PLACENTA WAS NOT COLLECTED:


Label

Code

Go To

PARENT/GUARDIAN REFUSAL

1

SPECIMEN_DC_COMMENTS

NOT PART OF HOSPITAL PROCEDURES

2

SPECIMEN_DC_COMMENTS

FRESH PLACENTA WAS NOT AVAILABLE

3

REASON_FREPLAC_NOAVAIL

OTHER

-5



PI06000/(REASON_PLAC_NOCOLLECT_OTH). SPECIFY: __________________________________________


PROGRAMMER INSTRUCTIONS

  • GO TO SPECIMEN_DC_COMMENTS.


PI06010/(REASON_FREPLAC_NOAVAIL). WHY WAS THERE NO FRESH PLACENTA AVAILABLE?


Label

Code

Go To

PLACENTA WAS SENT TO PATHOLOGY WHERE TISSUE WAS FIXED

1

SPECIMEN_DC_COMMENTS

OTHER

-5


DON'T KNOW

-2

SPECIMEN_DC_COMMENTS


PI06020/(REASON_FREPLAC_NOAVAIL_OTH). SPECIFY: ______________________________________


PROGRAMMER INSTRUCTIONS

  • GO TO ​SPECIMEN_DC_COMMENTS.


PI06030/(PLAC_RESEARCH_PRIOR). WAS THE PLACENTA USED FOR CLINICAL OR NON-NCS RESEARCH PURPOSES PRIOR TO BEING ASSESSED BY NCS DATA COLLECTOR?


Label

Code

Go To

YES, CLINICAL USE

1

PLAC_PROCESS_WHERE

YES, NON-NCS RESEARCH PURPOSES

2

PLAC_PROCESS_WHERE

NO

3

PLAC_PROCESS_WHERE

OTHER USE

-5


DON'T KNOW

-2

PLAC_PROCESS_WHERE


PI06040/(PLAC_RESEARCH_PRIOR_OTH). SPECIFY: ________________________________________________________


PI06050/(PLAC_PROCESS_WHERE). WHERE DID THE PROCESSING OF THE PLACENTA OCCUR?


Label

Code

Go To

HOSPITAL

1

PLAC_WHO_COLLECT

SPSC

2

SPECIMEN_0_ID

OTHER

-5



PI06060/(PLAC_PROCESS_WHERE_OTH). SPECIFY: __________________________________________ 


PI06070/(SPECIMEN_0_ID). RECORD THE NCS SPECIMEN ID OF THE FULL PLACENTA

|___|___|___|___|___|___|___|___|___|-|___|___|___|___|


PROGRAMMER INSTRUCTIONS

  • DISPLAY HARD EDIT IF SPECIMEN ID IS NOT FORMATTED AS TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH TWO ALPHA, TWO NUMERIC CHARACTERS (AA#######-AA##)

  • GO TO ​FULL_PLAC_COMMENTS.


PI06100/(PLAC_WHO_COLLECT). WHO COLLECTED THE SPECIMEN?


Label

Code

Go To

HOSPITAL STAFF

1


NCS STAFF

2


DON'T KNOW

-2



PI12000. DATE THE PLACENTA WAS WEIGHED, PHOTOGRAPHED AND/OR SECTIONED:


(PLACENTA_WEIGH_MM) |___|___|

  M     M


Label

Code

Go To

NOT APPLICABLE

-7

PI13000


(PLACENTA_WEIGH_DD) |___|___|

  D     D


(PLACENTA_WEIGH_YYYY) |___|___|___|___|

  Y      Y    Y     Y


PI13000. TIME THE PROCEDURES TO WEIGH AND/OR PHOTOGRAPH PLACENTA BEGAN:


(PLACENTA_WEIGH_TIME) |___|___|:|___|___|

  H      H      M    M


Label

Code

Go To

NOT APPLICABLE

-7

PLACENTA_WEIGHT


(PLACENTA_WEIGH_TIME_UNIT)


Label

Code

Go To

AM

1


PM

2



PI14000/(PLACENTA_WEIGHT). |___|___|___|___| g


Label

Code

Go To

UNABLE TO WEIGH

-8



PROGRAMMER INSTRUCTIONS

  • IF PLACENTA_WEIGHT = -8, GO TO PLACENTA_WEIGHT_OTH.

  • OTHERWISE, GO TO ?PLACENTA_PHOTO?.


PI15000/(PLACENTA_WEIGHT_OTH). SPECIFY WHY THE PLACENTA WAS NOT WEIGHED: ___________________________________________________


PI16000/(PLACENTA_PHOTO). WAS THE PLACENTA PHOTOGRAPHED?


Label

Code

Go To

YES

1

PLACENTA_SECTIONED

NO

2



PI17000/(PLACENTA_PHOTO_OTH). SPECIFY WHY THE PLACENTA WAS NOT PHOTOGRAPHED: _________________________________________


PI18000/(PLACENTA_SECTIONED). WAS THE PLACENTA SECTIONED?


Label

Code

Go To

YES

1

PI20000

NO

2



PI19000/(PLACENTA_SECTIONED_OTH). SPECIFY WHY THE PLACENTA WAS NOT SECTIONED: __________________________________________________


PROGRAMMER INSTRUCTIONS

  • GO TO SPECIMEN_DC_COMMENTS.


PI20000. TIME THE PROCEDURES TO SECTION THE PLACENTA BEGAN:


(PLACENTA_SECTION_TIME) |___|___|:|___|___|

  H      H      M    M


(PLACENTA_SECTION_TIME_UNIT)


Label

Code

Go To

AM

1


PM

2



PI21000/(PARTIAL_SAMP_LOC). PLEASE INDICATE THE LOCATION WHERE THE SAMPLE WAS TAKEN:


Label

Code

Go To

TOP-RIGHT SIDE

1

PLAC_SECTION_TWO

TOP-LEFT SIDE

2

PLAC_SECTION_TWO

RIGHT SIDE

3

PLAC_SECTION_TWO

LEFT SIDE

4

PLAC_SECTION_TWO

BOTTOM-RIGHT SIDE

5

PLAC_SECTION_TWO

BOTTOM-LEFT SIDE

6

PLAC_SECTION_TWO

MIDDLE

7

PLAC_SECTION_TWO

OTHER

-5



PI22000/(PARTIAL_SAMP_LOC_OTH). SPECIFY: ________________________________________________


PI23000/(PLAC_SECTION_TWO). WAS THE PLACENTA SECTION CUT INTO TWO PIECES?


Label

Code

Go To

YES

1

SPECIMEN_1_ID

NO

2



PI24000/(PLAC_SECTION_TWO_OTH). SPECIFY WHY NOT: _______________________________________________________


PI25000/(SPECIMEN_1_ID). RECORD THE NCS SPECIMEN ID

 

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


PROGRAMMER INSTRUCTIONS

  • DISPLAY HARD EDIT IF SPECIMEN ID IS NOT FORMATTED AS TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH TWO ALPHA, TWO NUMERIC CHARACTERS (AA#######-AA##)

  • IF PLAC_SECTION_TWO = 1, GO TO SPECIMEN_2_ID.

  • OTHERWISE, GO TO PI27000.


PI26000/(SPECIMEN_2_ID). RECORD THE NCS SPECIMEN ID

 

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


PROGRAMMER INSTRUCTIONS

  • DISPLAY HARD EDIT IF SPECIMEN ID IS NOT FORMATTED AS TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH TWO ALPHA, TWO NUMERIC CHARACTERS (AA#######-AA##)


PI27000. TIME THE PROCEDURES TO SECTION THE PLACENTA ENDED


(PLACENTA_SECTION_END_TIME) |___|___|:|___|___|

  H      H      M    M


(PLACENTA_SECTION_END_TIME_UNIT)


Label

Code

Go To

AM

1


PM

2



PI30000/(SPECIMEN_DC_COMMENTS). DO YOU HAVE ANY COMMENTS ABOUT THE PLACENTA COLLECTION THAT WERE NOT ALREADY NOTED?


Label

Code

Go To

YES

1


NO

2

TIME_STAMP_PI_ET


PI31000/(SPECIMEN_DC_COMMENTS_OTH). PLACENTA COLLECTION COMMENTS NOT ALREADY NOTED.

SPECIFY: _________________________________________________________


DATA COLLECTOR INSTRUCTIONS

  • IF THERE WERE ANY PLACENTA COLLECTION COMMENTS NOT ALREADY NOTED, ENTER THEM IN THE SPACE PROVIDED.


PROGRAMMER INSTRUCTIONS

  • GO TO TIME_STAMP_PI_ET.


PI32000/(FULL_PLAC_COMMENTS). DO YOU HAVE ANY COMMENTS ABOUT THE FULL PLACENTA COLLECTION THAT WERE NOT ALREADY NOTED?


Label

Code

Go To

YES

1


NO

2

TIME_STAMP_PI_ET


PI33000/(FULL_PLAC_COMMENTS_OTH). FULL PLACENTA COLLECTION COMMENTS NOT ALREADY NOTED.

SPECIFY: ________________________________________


DATA COLLECTOR INSTRUCTIONS

  • IF THERRE WERE ANY FULL PLACENTA COLLECTION COMMENTS NOT ALREADY NOTED, ENTER THEM IN THE SPACE PROVIDED.


(TIME_STAMP_PI_ET).


PROGRAMMER INSTRUCTIONS

  • INSERT DATE/TIME STAMP

  • IF PLAC_COLLECT = 2, GO TO TIME_STAMP_PFP_ET.

  • IF PLAC_COLLECT = 1, GO TO ​TIME_STAMP_PFP_ST.



PREPARATION FOR PLACENTA TRANSPORT


(TIME_STAMP_PFP_ST).


PROGRAMMER INSTRUCTIONS

INSERT DATE/TIME STAMP


PFP01000/(COLD_TEMP_MEASURE). ​TEMPERATURE OF REFRIGERATED CHAMBER


DATA COLLECTOR INSTRUCTIONS

  • PREPARE THE PLACENTA SPECIMEN FOR TRANSPORT.

  • IF ABLE TO MEASURE TEMPERATURE, THEN SELECT "TEMPERATURE." ENTER THE TEMPERATURE OF THE DIGITAL THERMOMETER IN THE TRANSPORT COOLER AT THE TIME THE DATA COLLECTOR PUTS THE SPECIMEN IN THE COOLER.

  • IF NOT ABLE TO MEASURE TEMPERATURE, THEN SELECT "NOT ABLE TO MEASURE" AND THE REASON THE TEMPERATURE COULD NOT BE RECORDED.

  • IF THERE ARE NOT ANY TUBES THAT REQUIRE REFRIGERATED TRANSPORT TEMPERATURES, THEN SELECT "NOT APPLICABLE."


Label

Code

Go To

TEMPERATURE

1


NOT ABLE TO MEASURE - THERMOMETER BROKEN

2


NOT ABLE TO MEASURE - THERMOMETER NOT AVAILABLE

3


NOT ABLE TO MEASURE - OTHER

-5


NOT APPLICABLE

-7



PFP02000/(COLD_TEMP_MEASURE_OTH). SPECIFY: ________________________________________


PROGRAMMER INSTRUCTIONS

  • GO TO ​TRANSPORT_COMMENT.


PFP03000. RECORD TEMPERATURE OF REFRIGERATED CHAMBER 


DATA COLLECTOR INSTRUCTIONS

  • RECORD THE TEMPERATURE OF THE REFRIGERATED CHAMBER OF THE TRANSPORT COOLER.


(COLD_TEMP) ENTER TEMPERATURE IN DEGREES CELSIUS  

|___|___|.|___|°C


(COLD_TEMP_POSNEG) ​RECORD IF THE TEMPERATURE IS A POSITIVE OR NEGATIVE VALUE


DATA COLLECTOR INSTRUCTIONS

  • IF TEMPERATURE IS ZERO OR ABOVE, RECORD "POSITIVE"

  • IF TEMPERATURE IS BELOW ZERO, RECORD "NEGATIVE"


Label

Code

Go To

POSITIVE

1


NEGATIVE

2



PROGRAMMER INSTRUCTIONS

  • SOFT EDIT: DISPLAY SOFT EDIT IF COLD_TEMP ≥ 10.0 OR ≤ 0.0

  • SOFT EDIT: DISPLAY SOFT EDIT IF NO VALUE ENTERED IN THE FIELD FOLLOWING THE DECIMAL POINT IN ​COLD_TEMP.


PFP04000/(TRANSPORT_COMMENT). TRANSPORT COMMENT


Label

Code

Go To

NO COMMENTS

1

TIME_STAMP_PFP_ET

COMMENT

2



SOURCE

​


PFP05000/(TRANSPORT_COMMENT_OTH). ____________________________________________


DATA COLLECTOR INSTRUCTIONS

  • ENTER ANY TRANSPORT COMMENT.


(TIME_STAMP_PFP_ET).


PROGRAMMER INSTRUCTIONS

INSERT DATE/TIME STAMP


 

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