Form 30.2 Survey

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

AdultUrineInstrument

Adult-Focused Biospecimen Collection (Preconception)

OMB: 0925-0593

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OMB #: 0925-0593

OMB Expiration Date: 8/31/2014

Adult Urine Instrument, Phase 2g

OMB Specification


Adult Urine Instrument


Event Category:

Trigger-Based, Pre-Preg, PV1, PV2; Time-Based, Birth, 6M, 12M, 36M, 60M

Event:

Pre-Preg, PV1, PV2, Birth, 6M, 12M, 36M, 60M

Instrument Target:

Pre-Pregnant Woman; Pregnant Women; Biological Mother; Primary Caregiver

Instrument Respondent:

Pre-Pregnant Woman; Pregnant Women; Biological Mother; Primary Caregiver

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:

11 minutes

Multiple Child/Sibling Consideration:

Per Event

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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Adult Urine Instrument



TABLE OF CONTENTS





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Adult Urine 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.





BIOSPECIMEN URINE COLLECTION


(TIME_STAMP_BUC_ST).


PROGRAMMER INSTRUCTIONS

  • INSERT DATE/TIME STAMP.

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


BUC01000/(URINE_INTRO). You will now collect a urine sample. I will need to ask you some questions before you collect your urine sample.


Label

Code

Go To

CONTINUE

1

BUC05000

REFUSED

-1



SOURCE

National Children’s Study, Legacy Phase


BUC02000/(REFUSAL_REASON). I am sorry that you have chosen not to participate in this collection. Can you tell me why?


DATA COLLECTOR INSTRUCTIONS

  • ENTER REASON FOR REFUSAL.


Label

Code

Go To

PHYSICAL LIMITATION

1

BUC04000

PARTICIPANT ILL/EMERGENCY

2

BUC04000

LANGUAGE ISSUE

3

BUC04000

NO TIME

4

BUC04000

UNABLE TO URINATE

5

BUC04000

UNCOMFORTABLE WITH COLLECTION PROCEDURES

6

BUC04000

OTHER

-5


REFUSED

-1

BUC04000

DON’T KNOW

-2

BUC04000


SOURCE

National Children’s Study, Legacy Phase (Modified) (6M Child)


BUC03000/(REFUSAL_REASON_OTH). SPECIFY: ____________________________________________ 


SOURCE

National Children’s Study, Legacy Phase (Modified) (6M Child)


BUC04000. That’s fine. Thank you for your time.   


SOURCE

New


DATA COLLECTOR INSTRUCTIONS

  • GO TO COLLECTION_COMMENT


BUC05000. When did you last urinate? 


DATA COLLECTOR INSTRUCTIONS

  • RECORD DATE AS “MMDDYYYY.”

  • RECORD THE TIME AS HH:MM. BE SURE TO FILL THE SPACE WITH A ZERO WHEN NECESSARY AND CHOOSE “AM” OR “PM”. FOR EXAMPLE, IF TIME OF LAST URINATION WAS AT 2:05 PM RECORD “02:05” AND CHOOSE “PM”.


SOURCE

National Children’s Study, Legacy Phase


(LT_URINE_MM) LAST URINATION – DATE: MONTH

 

|___|___|

  M     M       


Label

Code

Go To

REFUSED

-1


DON'T KNOW

-2



(LT_URINE_DD) LAST URINATION – DATE: DAY

 

|___|___|

  M     M   


Label

Code

Go To

REFUSED

-1


DON'T KNOW

-2



(LT_URINE_YYYY) LAST URINATION – DATE: YEAR

 

|___|___|___|___|

   Y     Y     Y    Y


(LT_URINE_TIME) LAST URINATION – TIME

 

|___|___| : |___|___|

   H     H        M     M


Label

Code

Go To

REFUSED

-1


DON'T KNOW

-2



(LT_URINE_TIME_UNIT) LAST URINATION – AM/PM


Label

Code

Go To

AM

1


PM

2


REFUSED

-1


DON'T KNOW

-2



BUC06000. When was the last time you had anything to eat or drink?


DATA COLLECTOR INSTRUCTIONS

  • RECORD THE LAST TIME PARTICIPANT ATE OR DRANK.

  • RECORD DATE AS “MMDDYYYY.”

  • RECORD THE TIME AS HH:MM. BE SURE TO FILL THE SPACE WITH A ZERO WHEN NECESSARY AND CHOOSE “AM” OR “PM”. FOR EXAMPLE, IF THE LAST TIME PARTICIPANT ATE OR DRANK WAS AT 2:05 PM RECORD “02:05” AND CHOOSE “PM”.


SOURCE

National Children’s Study, Legacy Phase (modified)


(LT_EAT_DRINK_MM) LAST TIME ATE OR DRANK – DATE: MONTH

 

|___|___| 

   M    M       


Label

Code

Go To

REFUSED

-1


DON'T KNOW

-2



(LT_EAT_DRINK_DD) LAST TIME ATE OR DRANK – DATE: DAY

 

|___|___| 

   D    D     


Label

Code

Go To

REFUSED

-1


DON'T KNOW

-2



(LT_EAT_DRINK_YYYY) LAST TIME ATE OR DRANK – DATE: YEAR

 

|___|___|___|___| 

   Y     Y    Y      Y


(LT_EAT_DRINK_TIME) LAST TIME ATE OR DRANK – TIME

 

|___|___| : |___|___|

   H     H        M     M


(LT_EAT_DRINK_TIME_UNIT) LAST TIME ATE OR DRANK – AM/PM


Label

Code

Go To

AM

1


PM

2


REFUSED

-1


DON'T KNOW

-2



BUC07000/(ATE_MEAT). How much of what you ate was beef, pork, tuna, or salmon?


Label

Code

Go To

NONE

1


Less than one quarter of the meal

2


One quarter to one half of the meal

3


More than one-half but less than three quarters of the meal

4


Three quarters or more,but not all of the meal

5


All of the meal

6


REFUSED

-1


DON’T KNOW

-2



SOURCE

National Children’s Study, Legacy Phase


BUC08000/(CREATINE_SUPP). Do you take creatine supplements?


DATA COLLECTOR INSTRUCTIONS

  • IF THE PARTICIPANT ASKS, EXPLAIN THAT CREATINE SUPPLEMENTS ARE OFTEN TAKEN BY ATHLETES WISHING TO GAIN MUSCLE MASS.


Label

Code

Go To

YES

1


NO

2


REFUSED

-1


DON'T KNOW

-2



SOURCE

National Children’s Study, Legacy Phase


BUC09000/(SPECIMEN_STATUS). URINE COLLECTION STATUS


DATA COLLECTOR INSTRUCTIONS

  • READ URINE COLLECTION INSTRUCTIONS TO THE PARTICIPANT.

  • PREPARE THE WORK AREA WHILE THE PARTICIPANT IS COLLECTING SPECIMEN.

  • PUT ON LAB COAT AND GLOVES.

  • THANK THE PARTICIPANT FOR THEIR SAMPLE (OR FOR TRYING IF NO SAMPLE WAS COLLECTED).

  • ENTER THE STATUS OF THE URINE COLLECTION


Label

Code

Go To

COLLECTED

1


NOT COLLECTED

2



PROGRAMMER INSTRUCTIONS

  • IF SPECIMEN_STATUS = 2, GO TO SPECIMEN_COMMENTS.

  • IF SPECIMEN_STATUS = 1, AND

    • IF EVENT_TYPE = 18 (BIRTH EVENT), GO TO NCS_CUP.

    • OTHERWISE, IF EVENT_TYPE ≠ 18 (BIRTH EVENT), GO TO SPECIMEN_ID.


BUC10000/(SPECIMEN_COMMENTS). URINE COLLECTION TECHNICAL COMMENTS


DATA COLLECTOR INSTRUCTIONS

  • ENTER THE REASON THE SAMPLE WAS NOT COLLECTED.

  • SELECT ONLY ONE RESPONSE.


Label

Code

Go To

PHYSICAL LIMITATION

1

COLLECTION_COMMENT

PARTICIPANT ILL/ EMERGENCY

2

COLLECTION_COMMENT

COLLECTION SUPPLIES MALFUNCTIONED

3

COLLECTION_COMMENT

QUANTITY NOT SUFFICIENT

4

COLLECTION_COMMENT

LANGUAGE ISSUE, SPANISH

5

COLLECTION_COMMENT

LANGUAGE ISSUE, NON SPANISH

6

COLLECTION_COMMENT

COGNITIVE DISABILITY

7

COLLECTION_COMMENT

NO TIME

8

COLLECTION_COMMENT

OTHER

-5


REFUSED

-1

COLLECTION_COMMENT

DON’T KNOW

-2

COLLECTION_COMMENT


BUC11000/(SPECIMEN_COMMENT_OTH). URINE COLLECTION TECHNICAL COMMENT OTHER SPECIFY

 

____________________________________________ 


DATA COLLECTOR INSTRUCTIONS

  • IF THERE ARE ANY OTHER URINE COLLECTION TECHNICAL COMMENTS NOT LISTED IN THE PREVIOUS QUESTION, ENTER THE REASON BELOW.


PROGRAMMER INSTRUCTIONS

  • GO TO COLLECTION_COMMENT.


BUC12000/(NCS_CUP). WAS AN NCS-PROVIDED URINE CUP USED FOR THE SPECIMEN COLLECTION?


Label

Code

Go To

YES

1


NO

2


REFUSED

-1


DON'T KNOW

-2



BUC13000/(SPECIMEN_ID). SPECIMEN ID 

 

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


DATA COLLECTOR INSTRUCTIONS

  • RECORD URINE COLLECTION CUP SPECIMEN ID WHEN PARTICIPANT RETURNS WITH THE SAMPLE.

  • IMMEDIATELY PLACE COLLECTION CUP IN DRY ICE CHAMBER OF THE TRANSPORT COOLER PER TRANSPORT INSTRUCTIONS.


PROGRAMMER INSTRUCTIONS

  • CANNOT BE NULL

  • HARD EDIT: INCLUDE HARD EDIT IF FORMAT IS NOT TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH TWO ALPHA, TWO NUMERIC CHARACTERS (AA # # # # # # #-AA##)


BUC14000.


DATA COLLECTOR INSTRUCTIONS

  • RECORD DATE AND TIME THE ADULT URINE SPECIMEN WAS COLLECTED.

  • RECORD THE DATE AS TWO DIGIT MONTH, TWO DIGIT DAY, AND FOUR DIGIT YEAR.

  • RECORD THE TIME AS HH:MM, 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 ADULT URINE SAMPLE WAS COLLECTED AT 2:05PM, RECORD “02:05” AND CHOOSE “PM”.


(A_URINE_COLL_MM) DATE ADULT URINE SPECIMEN WAS COLLECTED - MONTH

 

|___|___|

   M    M         


(A_URINE_COLL_DD) DATE ADULT URINE SPECIMEN WAS COLLECTED - DAY

 

|___|___|

   D    D   


(A_URINE_COLL_YYYY) DATE ADULT URINE SPECIMEN WAS COLLECTED - YEAR

 

|___|___|___|___|

   Y    Y     Y    Y  


(A_URINE_COLL_TIME) TIME ADULT URINE SPECIMEN COLLECTED

 

|___|___|:|___|___|

   H     H       M    M


(A_URINE_COLL_TIME_UNIT) TIME ADULT URINE SPECIMEN COLLECTED - AM/PM


Label

Code

Go To

AM

1


PM

2



BUC15000/(COLLECTION_LOCATION). COLLECTION LOCATION


DATA COLLECTOR INSTRUCTIONS

  • RECORD WHERE URINE COLLECTION OCCURRED.


Label

Code

Go To

HOME

1

BUC16000

CLINIC

2

BUC16000

HOSPITAL

3

BUC16000

OTHER LOCATION

-5



BUC15100/(COLLECTION_LOCATION_OTH). SPECIFY: ______________________________________________


BUC16000. Thank you for your time and participation in this sample collection.


SOURCE

National Children's Study, Vanguard Phase


BUC17000/(COLLECTION_COMMENT). RECORD ANY COMMENTS ABOUT THE ADULT URINE COLLECTION.


DATA COLLECTOR INSTRUCTIONS

  • DOCUMENT ANY PROBLEMS OR CONCERNS ABOUT THE ADULT URINE COLLECTION PROCEDURE.


Label

Code

Go To

NO COMMENTS

1

TIME_STAMP_BUC_ET

COMMENTS

2



BUC18000/(COLLECTION_COMMENT_OTH). SPECIFY:       ________________________


(TIME_STAMP_BUC_ET).


PROGRAMMER INSTRUCTIONS

  • INSERT DATE/TIME STAMP


Public reporting burden for this collection of information is estimated to average 11 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0593*). Do not return the completed form to this address.

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