Form 1 Survey

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

_________

18500501

01/04/2008