A.2.3 Instruments

Appendix A A.2.3.l–4

National Children’s Study

P1 Blood Draw Data Collection Form

Part A: Administrative
Date: |__|__| / |__|__| / |__|2___0_|__|__| Time collection started: |__|__|:|__|__| 1 am 2 pm Time collection stopped: |__|__|:|__|__| 1 am 2 pm		Section Status (Select one) Complete 1 Partial Complete 2 Not Done 3 Reason for Not Done/Partial (Select one) SP Refusal 1 SP III/Emergency 3 No Time 4 Safety Exclusion 10 Physical Limitation 11 Defective Collection Kit 15 Language Issue, Spanish 17 Language Issue, Non-Spanish 18 Cognitive Disability 20 No Time (no appt. set for next data collection) 25 Other Specify___________________ 96
Assignment ID: |___|___|___|___|___|___| Participant ID: |___|___|___|___|___|___| Data Collector ID: |___|___|___|___| Site ID: |___|___|___|___| Visit location: 1 Home 2 Clinic/Office Participant’s age |__|__| years
Part B: Blood Collection Questions (Ask these questions at all visits when blood is drawn.)
1) Do you have hemophilia or any bleeding disorder? 1 Yes (Go to Part D) 2 No 97 Refuse 98 Don’t Know
2) Do you take any blood-thinning medication, such as Coumadin or Warfarin? 1 Yes (Go to Part D) 2 No 97 Refuse 98 Don’t Know
3) Have you had cancer chemotherapy within the past 4 weeks? 1 Yes (Go to Part D) 2 No 97 Refuse 98 Don’t Know
4) Have you had any problems with a blood draw in the past? 1 Yes 2 No (Go to Q 6) 97 Refuse (Go to Q 6) 98 Don’t know ( Go to Q 6)
5) What problems did you have with a blood draw in the past? (Check all that apply) Fainting 1 Light-headedness 2 Hematoma 3 Bruising 4 Other Specify___________________ 96 Refused 97 Don’t know 97
6) When was the last time you had anything to eat or drink? |__|__|:|__|__| 1 am 2 pm
7) Is this a fasting blood sample? (If the answer to Question 6 is less than 8 hours ago the answer is No.) 1 Yes 2 No
Part C: Blood Collection
Kit ID: (Affix Pre-printed Blood Kit ID Label Here)
Data Collector ID: |___|___|___|___|
Blood Collection Status (Select one) Collected 1 Partial Collected 2 Not collected 3 Reason for Partial/Not Collected (Select one) Safety Exclusion 1 Physical Limitations 2 Participant III/ Emergency 3 Equipment Failure 4 No Suitable Vein 5 Hematoma 6 Fainting 7 Light-Headedness 8 Communication Problem 9 No Time 10 Other Specify___________________ 96 Refused 97 (Go to Part D)
Blood Collection Tubes
LPS-0001	1 Collected 2 Partial Collected 3 Not Collected
	Reason for not collected or partial: Equipment Failure 3 Fainting 4 Light-Headedness 5 Hematoma 6			Bruising 7 Vein Collapsed During the Procedure 8 Other, Specify_________ 96 Refuse 97
RED-0001	1 Collected 2 Partial Collected 3 Not Collected
	Reason for not collected or partial: Equipment Failure 3 Fainting 4 Light-Headedness 5 Hematoma 6			Bruising 7 Vein Collapsed During the Procedure 8 Other, Specify_________ 96 Refuse 97
RED-0002	1 Collected 2 Partial Collected 3 Not Collected
	Reason for not collected or partial: Equipment Failure 3 Fainting 4 Light-Headedness 5 Hematoma 6			Bruising 7 Vein Collapsed During the Procedure 8 Other, Specify_________ 96 Refuse 97
RED-0003	1 Collected 2 Partial Collected 3 Not Collected
	Reason for not collected or partial: Equipment Failure 3 Fainting 4 Light-Headedness 5 Hematoma 6			Bruising 7 Vein Collapsed During the Procedure 8 Other, Specify_________ 96 Refuse 97
LAV-0001	1 Collected 2 Partial Collected 3 Not Collected
	Reason for not collected or partial: Equipment Failure 3 Fainting 4 Light-Headedness 5 Hematoma 6			Bruising 7 Vein Collapsed During the Procedure 8 Other, Specify_________ 96 Refuse 97
Blood Collection Comment:________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________
Part D Saliva Collection (Only use if blood collection is refused or not possible)
Because you have hemophilia, are taking blood thinning medication, have had chemotherapy recently, or refused the blood draw, we will not be able to draw your blood at this time. Several measures that are performed in blood can be measured in saliva. Are you able to provide a saliva sample? 1 Yes 2 No BE SURE TO REVIEW SALIVA SAMPLE COLLECTION INSTRUCTIONS WITH THE PARTICIPANT
Data Collector ID: |___|___|___|___|
Kit ID: (Affix Pre-Printed Saliva Kit ID Label Here)
1 Collected 2 Partial Collected 3 Not Collected
Reason not done or partial: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3			Other, Specify_________ 96 Refuse 97 Could Not Obtain 99
Saliva Comments: ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________

Initials QC

_________

National Children’s Study

Adult Blood Data Collection Form-T1 Mom

(Only for use when CHITA is not available)

Part A: Administrative
Date: |__|__| / |__|__| / |__|2___0_|__|__| Data Collector ID: |___|___|___|___| Visit location: Home 1 Clinic/Office 2	Section Status (Select one) Complete 1 Partial Complete 2 Not Done 3 Reason for Not Done/Partial (Select one) SP Refusal (Go to Part D) 1 SP III/ Emergency 3 No Time 4 Safety Exclusions (Go to Part D) 10 Physical Limitation (Go to Part D) 11 Quantity Not Sufficient 14 Defective Collection Kit 15 Language Issue, Spanish 17 Language Issue, Non-Spanish 18 Cognitive Disability 20 No Time (no appt. set for next data collection) 25 Other, Specify___________________ 96
Time kit opened: |__|__|:|__|__| am 1 pm 2 Place Adult Blood Collection –T1 Mom or Saliva BNC Collection Kit Label Here Time collection stopped: |__|__|:|__|__| am 1 pm 2
Part B: Blood Pre-Screening Questions (Ask these questions at all visits when blood is drawn.)
1) Do you have hemophilia or any bleeding disorder? Yes (Go to Part D) 1 No 2 Refused 97 Don’t know 98
2) Do you take any blood thinning medication, such as Coumadin or warfarin? Yes (Go to Part D) 1 No 2 Refused 97 Don’t know 98
3) Have you had cancer chemotherapy within the past 4 weeks? Yes (Go to Part D) 1 No 2 Refused 97 Don’t know 98
4) Have you had any problems with a blood draw in the past? Yes 1 No (Go to Part C) 2 Refused (Go to part C) 97 Don’t know (Go to Part C) 98
5). What problems did you have with a blood draw in the past? (Check all that apply) Fainting 1 Light-headedness 2 Hematoma 3 Bruising 4		Other, Specify___________________ 96 Refused 97 Don’t know 98

Part C: Blood Collection Tubes
LP01 3mL Lavender Prescreened	Collected 1 Partial Collected 2 Not Colleted 3
	Reason for not collected or partial: Equipment failure 3 Fainting 4 Light-headedness 5 Hematoma 6	Bruising 7 Vein collapsed during the procedure 8 Other, Specify_________ 96 Refused 97
RD01 10 mL Red Top 01	Collected 1 Partial Collected 2 Not Colleted 3
	Reason for not collected or partial: Equipment failure 3 Fainting 4 Light-headedness 5 Hematoma 6	Bruising 7 Vein collapsed during the procedure 8 Other, Specify_________ 96 Refused 97
RD04 10mL Red Top 04	Collected 1 Partial Collected 2 Not Colleted 3
	Reason for not collected or partial: Equipment failure 3 Fainting 4 Light-headedness 5 Hematoma 6	Bruising 7 Vein collapsed during the procedure 8 Other, Specify_________ 96 Refused 97
RD03 10 mLRed top 03 SST	Collected 1 Partial Collected 2 Not Colleted 3
	Reason for not collected or partial: Equipment failure 3 Fainting 4 Light-headedness 5 Hematoma 6	Bruising 7 Vein collapsed during the procedure 8 Other, Specify_________ 96 Refused 97

LV03 Lavender Top 03 6 mL EDTA	Collected 1 Partial Collected 2 Not Colleted 3
	Reason for not collected or partial: Equipment failure 3 Fainting 4 Light-headedness 5 Hematoma 6		Bruising 7 Vein collapsed during the procedure 8 Other, Specify_________ 96 Refused 97
LV02 Lavender Top 02 PPT	Collected 1 Partial Collected 2 Not Colleted 3
	Reason for not collected or partial: Equipment failure 3 Fainting 4 Light-headedness 5 Hematoma 6		Bruising 7 Vein collapsed during the procedure 8 Other, Specify_________ 96 Refused 97
LV04 Lavender Top 04 P100	Collected 1 Partial Collected 2 Not Colleted 3
	Reason for not collected or partial: Equipment failure 3 Fainting 4 Light-headedness 5 Hematoma 6		Bruising 7 Vein collapsed during the procedure 8 Other, Specify_________ 96 Refused 97
Blood Collection Comment:________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________
Part D Saliva BNC Collection (Only use if blood collection is refused or not possible)
Because you have hemophilia, are taking blood thinning medication, have had chemotherapy recently, or refused the blood draw, we will not be able to draw your blood at this time. Several measures that are performed in blood can be measured in saliva. Are you able to provide a saliva sample? Yes 1 No 2 BE SURE TO REVIEW SALIVA SAMPLE COLLECTION INSTRUCTIONS WITH THE PARTICIPANT
Collected 1 Partial Collected 2 Not Colleted 3
Reason not done or partial: No time 1 SP Ill/Emergency 2 Equipment failure 3		Other, Specify_________ 96 Refuse 97 Could not obtain 99
Saliva Comments: ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________
Part E: Transport Temperatures
Time placed in cold compartment for transport to SPSC: |__|__|:|__|__| am 1 pm 2 Cold Compartment temperature: |__|__|.|__| °C Cold Compartment Upper (15 °C) Temperature Threshold Monitor has been activated Yes 1 No 2 Cold Compartment Lower (0 °C)Temperature Threshold Monitor has been activated Yes 1 No 2 Ambient Compartment Temperature Threshold Monitor has been activated Yes 1 No 2 (The ambient compartment is only used for P100 tubes that have not been centrifuged)

Data Collector ID for QC

|___|___|___|___|

For Office Use Only

Participant # __ __ __ __ __

#__ __ __ __ __

National Children’s Study

Father Blood Draw Data Collection Form

Part A: Administrative
Date: |__|__| / |__|__| / |__|2___0_|__|__|		Section Status (Select one) Complete 1 Partial Complete 2 Not Done 3 Reason for Not Done/Partial (Select one) Safety Exclusion 1 Physical Limitations 2 Participant III/Emergency 3 Equipment Failure 4 Communication Problem 5 No Time 6 Other Specify___________________ 96 Refused 97 Don’t know 98
Assignment ID: |___|___|___|___|___|___| Participant ID: |___|___|___|___|___|___| Data Collector ID: |___|___|___|___| Site ID: |___|___|___|___| Participant’s age |__|__| years
Part B: Blood Collection Questions (Ask these questions at all visits when blood is drawn.)
1) Do you have hemophilia or any bleeding disorder? 1 Yes (Go to Part C) 2 No 97 Refuse 98 Don’t Know
2) Do you take any blood-thinning medication, such as Coumadin or Warfarin? 1 Yes (Go to Part C) 2 No 97 Refuse 98 Don’t Know
3) Have you had cancer chemotherapy within the past 4 weeks? 1 Yes (Go to Part C) 2 No 97 Refuse 98 Don’t Know
4) Have you had any problems with a blood draw in the past? 1 Yes 2 No (Go to Q 6) 97 Refuse (Go to Q 6) 98 Don’t Know ( Go to Q 6)
5) What problems did you have with a blood draw in the past? (Check all that apply) Fainting 1 Light-Headedness 2 Hematoma 3 Bruising 4 Other Specify___________________ 96 Refused 97 Don’t Know 97
6) When was the last time you had anything to eat or drink? |__|__|:|__|__| 1 am 2 pm
7) Is this a fasting blood sample? (If the answer to Question 6 is less than 8 hours ago the answer is No.) 1 Yes 2 No
Part C Saliva Collection (Only use if blood collection is refused or not possible)
8) Because you {have hemophilia; are taking blood thinning medication; have had chemotherapy recently} we will not be able to draw your blood at this time. Several measures that are performed in blood can be measured in saliva. Are you able to provide a saliva sample? 1 Yes 2 No BE SURE TO REVIEW SALIVA SAMPLE COLLECTION INSTRUCTIONS WITH THE PARTICIPANT
Kit ID: |___|___|___|___|___|___|___|___|___|___|___|___|
9) Saliva collection status 1 Collected 2 Not Collected Reason for not collecting No Time 1 Participant III/Emergency 2 Equipment Failure 3 Other Specify___________________ 96 Refused 97 Don’t Know 98 Could Not Obtain 99
Saliva Comments: ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________
Part D Tubes to be Drawn
Kit ID: |___|___|___|___|___|___|___|___|___|___|___|___|
Red top (10ml)	1 Collected 2 Not Collected Reason for not collecting: No time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5		Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97 Don’t Know 98
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
Lavender top (10ml)	1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5			Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97 Don’t Know 98
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
Pre-screened lavender top (10ml)	1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5			Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97 Don’t Know 98
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
ACD/PBMC tube	1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5			Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97 Don’t Know 98
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
Blood Collection Comment:________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________

For Office Use Only

Participant # __ __ __ __ __

#__ __ __ __ __

National Children’s Study

T3 Mother Blood Draw Data Collection Form

Part A: Administrative
Date: |__|__| / |__|__| / |__|2___0_|__|__|		Section Status (Select one) Complete 1 Partial Complete 2 Not Done 3 Reason for Not Done/Partial (Select one) Safety Exclusion 1 Physical Limitations 2 Participant III/Emergency 3 Equipment Failure 4 Communication Problem 5 No Time 6 Other Specify___________________ 96 Refused 97
Assignment ID: |___|___|___|___|___|___| Participant ID: |___|___|___|___|___|___| Data Collector ID: |___|___|___|___| Site ID: |___|___|___|___| Participant’s age |__|__| years
Part B: Blood Collection Questions
1) Do you have hemophilia or any bleeding disorder? 1 Yes (Go to Part C) 2 No 97 Refuse 98 Don’t Know
2) Do you take any blood-thinning medication, such as Coumadin or Warfarin? 1 Yes (Go to Part C) 2 No 97 Refuse 98 Don’t Know
3) Have you had cancer chemotherapy within the past 4 weeks? 1 Yes (Go to Part C) 2 No 97 Refuse 98 Don’t Know
4) Have you had any problems with a blood draw in the past? 1 Yes 2 No (Go to Q 6) 97 Refuse (Go to Q 6) 98 Don’t Know ( Go to Q 6)
5). What problems did you have with a blood draw in the past? (Check all that apply) Fainting 4 Light-Headedness 5 Hematoma 6				Bruising 7 Other, Specify_________ 96 Refuse 97 Don’t Know 98
6) When was the last time you had anything to eat or drink? |__|__|:|__|__| . 1 am 2 pm
7) Is this a fasting blood sample? (If the answer to Question 6 is less than 8 hours ago the answer is No.) 1 Yes 2 No
8) Have you had coffee or tea today? 1 Yes 2 No 97 Refuse 98 Don’t Know
9) Have you had alcohol such as beer wine or liquor today? 1 Yes 2 No 97 Refuse 98 Don’t Know
10) Have you chewed gum, used breath mints, lozenges or cough drops, or other cough or cold remedies today? 1 Yes 2 No 97 Refuse 98 Don’t Know
11) Have you used antacid, laxatives, or anti-diarrheals today? 1 Yes 2 No 97 Refuse 98 Don’t Know
12) Have you taken a dietary supplement such as vitamins or minerals today? 1 Yes 2 No 97 Refuse 98 Don’t Know
Part C Saliva Collection (Only use if blood collection is refused or not possible)
13) Because you {have hemophilia; are taking blood thinning medication; have had chemotherapy recently} we will not be able to draw your blood at this time. Several measures that are performed in blood can be measured in saliva. Are you able to provide a saliva sample? 1 Yes 2 No BE SURE TO REVIEW SALIVA SAMPLE COLLECTION INSTRUCTIONS WITH THE PARTICIPANT
Kit ID: |___|___|___|___|___|___|___|___|___|___|___|___|
Data Collector ID: |___|___|___|___|
Saliva Status 1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3			Other, Specify_________ 96 Refuse 97 Could Not Obtain 99
Saliva Comments: ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________
Part D Tubes to be drawn
Kit ID: |___|___|___|___|___|___|___|___|___|___|___|___|
Data Collector ID: |___|___|___|___|
Red top (10ml)	1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5			Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
Red top (10ml)	1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5				Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
Red top (10ml)	1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5				Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
PBMC (10ml)	1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5				Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
Lavender EDTA (10ml)	1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5				Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
Lavender EDTA (10ml)	1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5				Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
Gray top NaF (4 ml)	1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5				Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
PAX GENE RNA (10ml)	1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5				Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
Blood Collection Comment:________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________

For Office Use Only

Participant # __ __ __ __ __

Assignment #__ __ __ __ __

National Children’s Study

Birth Maternal Blood Data Collection Form

Part A: Administrative
Mother’s name:_____________________ Name of Hospital___________________ SC/VC ID: _______________________________	Date of collection:_____/_____/_______ Time of collection: _____:_____ am pm Staff ID________________ Hospital NCS
Part B: Precollection Questions
Do you have hemophilia or any bleeding disorder?				Yes No Don’t Know Refused
Do you take any blood-thinning medication, such as Coumadin or Warfarin?				Yes No Don’t Know Refused
Have you had cancer chemotherapy within the past 4 weeks?				Yes No Don’t Know Refused
Have you had any problems with a blood draw in the past?				Yes Fainting Light-Headedness Hematoma Bruising Other No Don’t Know Refused
When was the last time you had anything to eat or drink, other than water?				Time: _____: ____ am pm Don’t Know Refused
Part C: Samples Collected
Kit ID:_____________________________
Position of participant:			Sitting Reclining
Tube type		Sample ID
3 mL prescreened Lavender EDTA tube for metals
10 mL Red Top #1
10 mL Red Top #2
10 mL Red Top #3
Part D: Comments

For Office Use Only

Participant # __ __ __ __ __

#__ __ __ __ __

National Children’s Study

Child 12 Months Blood Draw Data Collection Form

Part A: Administrative
Date: |__|__| / |__|__| / |__|2___0_|__|__|		Section Status (Select one) Complete 1 Partial Complete 2 Not Done 3 Reason for Not Done/Partial (Select one) Safety Exclusion 1 Physical Limitations 2 Participant III/Emergency 3 Equipment Failure 4 Communication Problem 5 No Time 6 Other Specify___________________ 96 Refused 97 Don’t Know 98
Assignment ID: |___|___|___|___|___|___| Participant ID: |___|___|___|___|___|___| Data Collector ID: |___|___|___|___| Site ID: |___|___|___|___| Participant’s age |__|__| months
Part B: Blood Collection Questions (Ask these questions at all visits when blood is drawn for the child.)
1) Does _____ (child’s name) have hemophilia or any bleeding disorder? 1 Yes (Go to Part C) 2 No 97 Refuse 98 Don’t Know
2) Does _____ (child’s name) take any blood-thinning medication, such as Coumadin or Warfarin? 1 Yes (Go to Part C) 2 No 97 Refuse 98 Don’t Know
3) Has _____ (child’s name) had cancer chemotherapy within the past 4 weeks? 1 Yes (Go to Part C) 2 No 97 Refuse 98 Don’t Know
4) Has _____ (child’s name) had any problems with a blood draw in the past? 1 Yes 2 No (Go to Q 6) 97 Refuse (Go to Q 6) 98 Don’t Know ( Go to Q 6)
5). What problems did _____ (child’s name) have with a blood draw in the past? (Check all that apply) Fainting 1 Light-Headedness 2 Hematoma 3 Bruising 4 Other Specify___________________ 96 Refused 97 Don’t Know 97
6) When was the last time _____ (child’s name) had anything to eat or drink? |__|__|:|__|__| 1 am 2 pm
7) Is this a fasting blood sample? (If the answer to Question 6 is less than 8 hours ago the answer is No.) 1 Yes 2 No
Part C Saliva Collection (Only use if blood collection is refused or not possible)
8) Because your child {has hemophilia; is taking blood thinning medication; has had chemotherapy recently} we will not be able to draw his/her blood at this time. Several measures that are performed in blood can be measured in saliva. Is _____ (child’s name) able to provide a saliva sample? 1Yes 2 No BE SURE TO REVIEW SALIVA SAMPLE COLLECTION INSTRUCTIONS WITH THE PARTICIPANT
Kit ID: |___|___|___|___|___|___|___|___|___|___|___|___|
9) Saliva collection status 1 Collected 2 Not Collected Reason for not collecting No Time 1 Participant III/Emergency 2 Equipment Failure 3 Other Specify___________________ 96 Refused 97 Don’t Know 98 Could Not Obtain 99
Saliva Comments: ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________
Part D Tubes to be drawn for Child at 12 Months
Kit ID: |___|___|___|___|___|___|___|___|___|___|___|___|
Red top (5ml)	1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5		Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97 Don’t Know 98
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
Red top (5ml)	1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5			Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97 Don’t Know 98
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
Lavender top (6ml)	1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5			Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97 Don’t Know 98
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
Pre-screened lavender top (3ml)	1 Collected 2 Not Collected Reason for not collecting: No Time 1 Participant Ill/Emergency 2 Equipment Failure 3 Fainting 4 Light-Headedness 5			Hematoma 6 Bruising 7 Vein Collapsed During the Procedure 8 No Suitable Vein 9 Other, Specify_________ 96 Refuse 97 Don’t Know 98
Tube barcode	|___|___|___|___|___|___|___|___|___|___|___|___|
Blood Collection Comment:________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________