16.4 Survey

OMB #: 0925-0593

OMB Expiration Date: 07/31/ 2013

Biospecimen Child Saliva Collection Instrument, Phase 2e

Biospecimen Child Saliva Collection Instrument

Event:	12 Month
Participant:	Child
Respondent:	Parent/Caregiver
Domain:	Biospecimen
Type of Document: Allowable Mode: Allowable Method:	Data Collection Instrument In Person CAPI
Recruitment Groups:	EH, PB, HI
Version:	1.0
Release:	MDES 3.0

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Biospecimen Child Saliva Collection Instrument

TABLE OF CONTENTS

Biospecimen Saliva Collection

1

Biospecimen Child Saliva Collection Instrument

(TIME_STAMP_1) PROGRAMMER INSTRUCTION:

• INSERT DATE/TIME STAMP

PROGRAMMER INSTRUCTIONS:

• PRELOAD PARTICIPANT ID (P_ID) FOR CHILD AND RESPONDENT ID (R_P_ID) FOR RESPONDENT,

• PRELOAD CHILD’S FIRST NAME AND DISPLAY NAME IN C_FNAME THROUGHOUT INSTRUMENT.

• USE “the child” IN APPROPRIATE FIELDS THROUGHOUT THE INSTRUMENT IF CHILD’S NAME IS REFUSED OR DON’T KNOW.

• PRELOAD CHILD_SEX

• IF CHILD_SEX = 1, DISPLAY “his” AND “he” IN APPROPRIATE FIELDS THROUGHOUT INSTRUMENT.

• IF CHILD_SEX = 2, DISPLAY “her” AND “she” IN APPROPRIATE FIELDS THROUGHOUT INSTRUMENT.

SV0100/(SALIVA_COLLECT_OPTION). MODE OF SALIVA COLLECTION

DATA COLLECTOR INSTRUCTION:

• FOLLOW THE STANDARD CHILD SALIVA COLLECTION PROCEDURES TO DETERMINE THE MODE OF CHILD SALIVA COLLECTION.

COLLECTION AT THE TIME OF VISIT 1 (SALIVA_INTRO_COLLECTOR)

CHILD’S PARENT/CAREGIVER AT HOME 2

SV0200/(SALIVA_INTRO_PARENT). Thank you for agreeing to collect a sample of

{C_FNAME/the child}’s saliva. I will explain the collection materials and instructions.

DATA COLLECTOR INSTRUCTIONS:

• IF THE CHILD’S MOTHER, FATHER, OR CAREGIVER AGREES TO COLLECT SALIVA SPECIMEN AT HOME, REVIEW THE COLLECTION MATERIALS, COLLECTION INSTRUCTIONS, AND DATA COLLECTION FORM WITH THE PARENT OR CAREGIVER.

• RECORD AGREEMENT OR REFUSAL TO COLLECT SALIVA SPECIMEN.

AGREED 1 (DISTRIBUTE)

REFUSED -1

SV0300. Thank you for your time. (KIT_REAS_RF)

SV0400/(DISTRIBUTE). WERE YOU ABLE TO HAND THE KIT TO THE PARENT OR CAREGIVER?

YES 1

NO 2 (N_DISTRIB_REAS)

SV0500/(SPECIMEN_ID) RECORD THE SPECIMEN ID

|A|A|__|__|__|__|__|__|__|- |S|C|__|__| (TIME_STAMP_2)

DATA COLLECTOR INSTRUCTION:

• IF THE PARENT OR CAREGIVER AGREES TO COLLECT SALIVA SPECIMEN AT HOME, RECORD THE SPECIMEN ID OF THE OUTER PLASTIC CASE PROVIDED TO HIM/HER.

PROGRAMMER INSTRUCTIONS:

• CANNOT BE NULL.

• HARD EDIT: INCLUDE HARD EDIT IF FORMAT IS NOT AA # # # # # # #-SC## (FORMAT MUST BE AA # # # # # # #-SC##).

SV0600/(N_DISTRIB_REAS). WHY COULDN’T YOU GIVE THE KIT TO THE PARENT OR CAREGIVER?

NONE GIVEN…………………………………1 (SV1000)

NO TIME………………………………………2 (SV1000)

TOO COMPLICATED ……………………….3 (SV1000)

OTHER………………………………………. -5

SV0700/(N_DISTRIB_REAS_OTH).

SPECIFY ______________________

PROGRAMMER INSTRUCTION:

• LIMIT TEXT TO 255 CHARACTERS.

SV1000. That’s fine. Thank you for your time. (TIME_STAMP_2)

SV1100/(SALIVA_INTRO_COLLECTOR). I would like to collect a sample of (CHILD’S NAME/ the child)’s saliva. Before I do so, I will explain this collection and ask you some questions.

DATA COLLECTOR INSTRUCTIONS:

• EXPLAIN THE CHILD SALIVA COLLECTION PROCEDURES TO THE PARENT OR CAREGIVER.

• BE SURE TO INFORM THE PARENT OR CAREGIVER THAT SHE/HE NEEDS TO BE PRESENT WHILE THE PROCEDURE IS BEING PERFORMED

• RECORD AGREEMENT OR REFUSAL TO COLLECT SALIVA SPECIMEN.

AGREED 1 (SV1300)

REFUSED -1

SV1200/(COLL_REFUSAL_REASON). I am sorry that you have chosen not to participate in this collection. Can you tell me why?

DATA COLLECTOR INSTRUCTION:

• SELECT REASON FOR REFUSAL.

CHILD IS SLEEPING/TIRED 1 (SV1220)

REFUSED -1 (SV1220)

DON’T KNOW -2 (SV1220)

OTHER -5

SV1210/(COLL_REFUSAL_REASON_OTH).

SPECIFY ____________________ (SV1220)

PROGRAMMER INSTRUCTION:

• LIMIT TEXT TO 255 CHARACTERS.

SV1220. That’s fine. Thank you for your time. (TIME_STAMP_2)

SV1300. When was the last time {CHILD’S NAME/the child} had anything to eat or drink other than water?

DATA COLLECTOR INSTRUCTIONS:

• RECORD THE LAST TIME CHILD ATE OR DRANK ANYTHING OTHER THAN WATER.

• 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 LAST TIME CHILD ATE OR DRANK WAS AT 2:05PM, RECORD “02:05” AND CHOOSE “PM”.

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

SV1310/(LAST_EAT_TIME). LAST TIME ATE OR DRANK – TIME

|___|___|:|___|___|

H H M M

REFUSED -1

DON’T KNOW -2

SV1320/(LAST _EAT_TIME_UNIT). LAST TIME ATE OR DRANK – AM/PM

AM 1

PM 2

SV1330/(LAST_EAT_DATE). LAST TIME ATE OR DRANK – DATE

|___|___|/|___|___|/|___|___|___|___|

M M D D Y Y Y Y

REFUSED -1

DON’T KNOW -2

PROGRAMMER INSTRUCTIONS:

• HARD EDIT: INCLUDE HARD EDIT IF HOURS, MINUTES, MONTH, OR DAY ARE NOT 2 DIGITS (FILL THE SPACE WITH 0 AS NECESSARY).

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

• HARD EDIT: INCLUDE HARD EDIT IF MINUTES ARE NOT BETWEEN 00 AND 59.

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

• HARD EDIT: INCLUDE HARD EDIT IF YEAR IS < 2012.

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

• FORMAT DATE AS YYYYMMDD.

SV1400/(SPECIMEN_STATUS). STATUS OF THE SALIVA COLLECTION

DATA COLLECTOR INSTRUCTION:

• ENTER THE STATUS OF THE SPECIMEN COLLECTION.

COLLECTED 1 (SALIVA_COLLECTOR)

NOT COLLECTED 2

SV1500/(NO_SPECIMEN_REASON).

DATA COLLECTOR INSTRUCTIONS:

• ENTER THE PRIMARY REASON WHY SPECIMEN WAS NOT COLLECTED.

• SELECT ONLY ONE RESPONSE.

CHILD UNHAPPY 1 (TIME_STAMP_2)

CHILD SLEEPY 2 (TIME_STAMP_2)

PHYSICAL LIMITATION 3 (TIME_STAMP_2)

PARENT/CAREGIVER ILL/EMERGENCY 4 (TIME_STAMP_2)

CHILD ILL/EMERGENCY 5 (TIME_STAMP_2)

COLLECTION SUPPLIES MALFUNCTIONED 6 (TIME_STAMP_2)

NO TIME 7 (TIME_STAMP_2)

OTHER -5

REFUSED -1 (TIME_STAMP_2)

DON’T KNOW -2 (TIME_STAMP_2)

SV1510/(NO_SPECIMEN_REASON_OTH).

SPECIFY: ________________________

PROGRAMMER INSTRUCTIONS:

• LIMIT TEXT TO 255 CHARACTERS

• GO TO TIME_STAMP_2.

SV1520/(SALIVA_COLLECTOR). WHO COLLECTED CHILD SALIVA SPECIMEN?

DATA COLLECTOR INSTRUCTIONS:

• RECORD WHO COLLECTED THE CHILD SALIVA SPECIMEN.

DATA COLLECTOR 1 (SPECIMEN_ID)

MOTHER 2 (SPECIMEN_ID)

FATHER……………………………… 3 (SPECIMEN_ID)

OTHER……………………………….. -5

SV1530/(SALIVA_COLLECTOR _OTH).

SPECIFY ____________________________

PROGRAMMER INSTRUCTION:

• LIMIT TEXT TO 255 CHARACTERS.

SV1600/(SPECIMEN_ID). RECORD THE SPECIMEN ID

|A|A|__|__|__|__|__|__|__|- |S|C|__|__|

DATA COLLECTOR INSTRUCTIONS:

• RECORD SALIVA COLLECTION SPECIMEN ID.

• FORMAT MUST BE AA # # # # # # #-SC##

PROGRAMMER INSTRUCTIONS:

• CANNOT BE NULL.

• HARD EDIT: INCLUDE HARD EDIT IF FORMAT IS NOT AA # # # # # # #-SC## (FORMAT MUST BE AA # # # # # # #-SC##).

SV1610/(C_SALIVA_COLL_DATE). DATE CHILD SALIVA SPECIMEN WAS COLLECTED

|___|___| / |___|___| / |___|___|___|___|

M M D D Y Y Y Y

SV1660/(C_SALIVA_COLL_TIME). TIME CHILD SALIVA SPECIMEN COLLECTED

|___|___|:|___|___|

H H M M

SV1670/(C_SALIVA_COLL_TIME_UNIT) AM/PM CHILD SALIVA SPECIMEN COLLECTED

AM 1

PM 2

DATA COLLECTOR INSTRUCTION:

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

PROGRAMMER INSTRUCTIONS:

• HARD EDIT: INCLUDE HARD EDIT IF HOURS, MINUTES, MONTH OR DAY ARE NOT 2 DIGITS (FILL THE SPACE WITH 0 AS NECESSARY)

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

• HARD EDIT: INCLUDE HARD EDIT IF MINUTES ARE NOT BETWEEN 00 AND 59

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

• HARD EDIT: INCLUDE HARD EDIT IF YEAR IS < 2012.

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

• FORMAT DATE AS YYYYMMDD

SV1700/(COLLECTION_COMMENT). RECORD ANY COMMENTS ABOUT THE COLLECTION.

DATA COLLECTOR INSTRUCTION:

• DOCUMENT ANY PROBLEMS OR CONCERNS ABOUT THE CHILD SALIVA COLLECTION PROCEDURE.

NO COMMENTS 1 (SV1800)

COMMENT 2

SV1700A/(COLLECTION_COMMENT_OTH).

SPECIFY: ________________________

PROGRAMMER INSTRUCTION:

• LIMIT TEXT TO 255 CHARACTERS.

SV1800. Thank you for providing your child’s saliva sample.

(TIME_STAMP_2) PROGRAMMER INSTRUCTION:

• INSERT DATE/TIME STAMP

Public reporting burden for this collection of information is estimated to average 15 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.