25.3 Survey

OMB #: 0925-0593

OMB Expiration Date: 8/31/2014

Adult Saliva Instrument, Phase 2g

OMB Specification

Adult Saliva Instrument

Event Category:	Time-Based
Event:	36M, 60M
Administration:	N/A
Instrument Target:	Primary Caregiver
Instrument Respondent:	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:	9 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.

This page intentionally left blank.

Adult Saliva Instrument

TABLE OF CONTENTS

GENERAL PROGRAMMER INSTRUCTIONS: 1

BIOSPECIMEN ADULT SALIVA INSTRUMENT 3

This page intentionally left blank.

Adult Saliva 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 ADULT SALIVA INSTRUMENT

(TIME_STAMP_BAS_ST).

PROGRAMMER INSTRUCTIONS

• INSERT DATE/TIME STAMP

• DERIVE VARIABLE ‘CURRENT_YEAR’ BASED ON THE CURRENT YEAR AND USE THROUGHOUT INSTRUMENT.

• PRELOAD PARTICIPANT ID (P_ID).

BAS01000/(SALIVA_INTRO_COLLECTOR). I would like to collect a sample of your saliva. Before I do so, I will explain this collection and ask you some questions.

DATA COLLECTOR INSTRUCTIONS

• EXPLAIN THE SALIVA COLLECTION PROCEDURES TO THE PARTICIPANT.

• IF THE PARTICIPANT REFUSES THE COLLECTION, SELECT REFUSED.  OTHERWISE, SELECT CONTINUE.

Label	Code	Go To
CONTINUE	1	BAS05000
REFUSED	-1

SOURCE

National Children’s Study, Legacy Phase

BAS02000/(COLL_REFUSAL_REASON). I am sorry that you have chosen not to participate in this collection. Can you tell me why?

DATA COLLECTOR INSTRUCTIONS

• SELECT REASON FOR REFUSAL.

Label	Code	Go To
NO TIME	1	BAS04000
REFUSED	-1	BAS04000
DON’T KNOW	-2	BAS04000
OTHER	-5

SOURCE

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

BAS03000/(COLL_REFUSAL_REASON_OTH). SPECIFY: ____________________        

Label	Code	Go To
REFUSED	-1
DON'T KNOW	-2

SOURCE

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

BAS04000. That’s fine.  Thank you for your time. 

PROGRAMMER INSTRUCTIONS

• GO TO COLLECTION_COMMENT.

BAS05000. When was the last time you had anything to eat or drink?

DATA COLLECTOR INSTRUCTIONS

• RECORD THE LAST TIME PARTICIPANT ATE OR DRANK ANYTHING.

• 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 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.

SOURCE

National Children’s Study, Legacy Phase

(LAST_EAT_TIME) LAST TIME ATE OR DRANK – TIME

 

|___|___|:|___|___|

  H      H      M     M

Label	Code	Go To
REFUSED	-1
DON'T KNOW	-2

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

Label	Code	Go To
AM	1
PM	2
REFUSED	-1
DON'T KNOW	-2

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

 

|___|___|

   M    M      

Label	Code	Go To
REFUSED	-1
DON'T KNOW	-2

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

 

|___|___|

   D    D   

Label	Code	Go To
REFUSED	-1
DON'T KNOW	-2

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

 

|___|___|___|___|

   Y    Y     Y     Y

Label	Code	Go To
REFUSED	-1
DON'T KNOW	-2

BAS06000/(SPECIMEN_STATUS). STATUS OF THE SALIVA COLLECTION

DATA COLLECTOR INSTRUCTIONS

• ENTER THE STATUS OF THE SPECIMEN COLLECTION.

Label	Code	Go To
COLLECTED	1	SPECIMEN_ID
NOT COLLECTED	2

BAS07000/(NO_SPECIMEN_REASON).

DATA COLLECTOR INSTRUCTIONS

• ENTER THE PRIMARY REASON WHY SPECIMEN WAS NOT COLLECTED.

• SELECT ONLY ONE RESPONSE.

Label	Code	Go To
PHYSICAL LIMITATION	1	COLLECTION_COMMENT
PARENT/CAREGIVER ILL/EMERGENCY	2	COLLECTION_COMMENT
CHILD ILL/EMERGENCY	3	COLLECTION_COMMENT
COLLECTION SUPPLIES MALFUNCTIONED	4	COLLECTION_COMMENT
NO TIME	5	COLLECTION_COMMENT
OTHER	-5
REFUSED	-1	COLLECTION_COMMENT
DON’T KNOW	-2	COLLECTION_COMMENT

BAS08000/(NO_SPECIMEN_REASON_OTH). SPECIFY:       ________________________ 

PROGRAMMER INSTRUCTIONS

• GO TO COLLECTION_COMMENT.

BAS09000/(SPECIMEN_ID). RECORD THE SPECIMEN ID

 

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

DATA COLLECTOR INSTRUCTIONS

• RECORD SALIVA COLLECTION SPECIMEN ID.

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##).

BAS10000.

DATA COLLECTOR INSTRUCTIONS

• RECORD DATE AND TIME THE ADULT SALIVA 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 SALIVA SAMPLE WAS COLLECTED AT 2:05PM, RECORD “02:05” AND CHOOSE “PM”.

(C_SALIVA_COLL_MM) DATE ADULT SALIVA SPECIMEN WAS COLLECTED - MONTH

 

|___|___| 

   M    M      

(C_SALIVA_COLL_DD) DATE ADULT SALIVA SPECIMEN WAS COLLECTED - DAY

 

|___|___| 

   D    D  

(C_SALIVA_COLL_YYYY) DATE ADULT SALIVA SPECIMEN WAS COLLECTED - YEAR

 

|___|___|___|___|

   Y    Y      Y     Y

(C_SALIVA_COLL_TIME) TIME ADULT SALIVA SPECIMEN COLLECTED

 

|___|___|:|___|___|

 H     H        M    M

(C_SALIVA_COLL_TIME_UNIT) AM/PM ADULT SALIVA SPECIMEN COLLECTED 

Label	Code	Go To
AM	1
PM	2

BAS11000. Thank you for providing your saliva sample.

SOURCE

National Children’s Study, Legacy Phase

BAS12000/(COLLECTION_COMMENT). RECORD ANY COMMENTS ABOUT THE ADULT SALIVA COLLECTION PROCEDURE.

DATA COLLECTOR INSTRUCTIONS

• DOCUMENT ANY COMMENTS ABOUT THE SALIVA COLLECTION PROCEDURE.

Label	Code	Go To
NO COMMENTS	1	TIME_STAMP_BAS_ET
COMMENTS	2

BAS13000/(COLLECTION_COMMENT_OTH). SPECIFY:       ________________________

(TIME_STAMP_BAS_ET).

PROGRAMMER INSTRUCTIONS

INSERT DATE/TIME STAMP

Public reporting burden for this collection of information is estimated to average 9 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.