Form 2d Biospecimen Collection Forms/Field Test

Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Attachment 2d
PATH Study Data Collection Instruments:
Biospecimen Collection Forms
July 23, 2012

Blood Data Collection Form
Respondent ID (Text Readable Barcode)
Date Printed

DCN

OMB Control Number: 0925-XXXX
Expiration Date:

PATH Study
Blood Data Collection Form
Part A: Administrative

1.

Part G: Blood Collection Status

Staff ID: Preprinted

1. Collection Status (Mark one):
Collected (End)
Attempted, Not Collected
Not Collected

2. Today’s Date:
|__|__|/|__|__|/|__|__|__|__|
M

M

D

D

Y

Y

Y

Y

1. Blood Collection:
Agreed
Not Agreed (Go to Part G)

2. Reason not collected (Mark one main reason):
Respondent refused
Safety exclusion
Respondent ill/emergency
No time
Cognitive disability
Language issue
Defective/missing collection supplies
Physical limitations (Specify): ______________________
Other--specify: __________________________________

Part B: Blood Suitability Questions

1. Have you had cancer chemotherapy within
the past 2 weeks?
Yes
No
Refused
Don’t
Know
2. Have you had any problems with a blood
draw in the past?
Yes
Refused (Go to Part C)
No (Go to Part C)
Don’t Know (Go To
Part C)
Part C: Blood Kit ID

1. Blood Kit ID:
(Place Label Here)

3. What problems have you had with a blood draw in the past?
(Mark all that apply.)
Fainting
Light-headedness
Hematoma
Bruising
Other- Specify _____________________________

Part D: Blood Tube Status

Blue Top Tube (BT01)

Full draw

Short draw

No draw

Red Top Tube #1 (RD01)

Full draw

Short draw

No draw

Red Top Tube #2 (RD02)

Full draw

Short draw

No draw

Lavender Tube #1 (LV01)

Full draw

Short draw

No draw

Lavender Tube #2 (LV02)

Full draw

Short draw

No draw

PAXgene Tube (PX01)

Full draw

Short draw

No draw

Part E: Blood Collection Results

1. Collection Time:
|__|__| : |__|__|
H

H

M

M

a.m.

p.m.

2. Time placed in shipping container:
|__|__| : |__|__|
H

H

M

M

a.m.

p.m.

3. Problems with the blood draw? (Mark all that apply.)
No problems
Fainting
Light-headedness
Hematoma
Bruising
Other- Specify ________________________

Part F: Comments



GO TO TOP OF FORM AND COMPLETE PART G BLOOD COLLECTION STATUS
Public reporting burden for this collection of information is estimated to average 3 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-XXXX). Do not return the completed form to this address.

Buccal Cell Data Collection Form
Respondent ID
Date Printed

DCN

OMB Control Number: 0925-XXXX
Expiration Date:

PATH Study

Buccal Cell Data Collection Form

Interviewer Administered

Part A: Administrative
1. Staff ID: Preprinted
2. Today’s Date:
|__|__|/|__|__|/|__|__|__|__|
M

M

D

D

Y

Y

Y

Y

3. Buccal Cell Collection:
Agreed
Not agreed (Go to Part E)
4. Buccal Cell Kit ID:
(Go to Part B)
(Place Label Here)

Part E: Buccal Cell Collection Status
1. Collection Status (Mark one):
Collected (End)
Attempted, not collected
Not collected
2. Reason Not Collected (Mark one main reason):
Respondent refused
No time
Respondent ill/emergency
Language issue
Cognitive disability
Defective/missing collection supplies
Sores/Ulcers
Cuts/Bleeding
Dry mouth
Cancer
Infection
Physical limitations (Specify): ______________________
Other--specify: __________________________________

Part B: Buccal Cell Collection Questions
1. Do you have any special conditions in your mouth (e.g. sores, signs of infection, bleeding, etc.)?
Yes

No (Go to Q3)

Don’t know (Go to Q3)

2. What mouth condition(s) do you have?
(Mark all that apply)
3. When was the last time you had anything to eat
or drink other than water?
Don’t know
Refused

Sores/Ulcers
Cuts/Bleeding
Dry mouth
Infection
Cancer
Other: _______________________________________
Date: |__|__| / |__|__| / |__|__|__|__|
M

Don’t know

Refused

M

D

D

Y

Time: |__|__| : |__|__|
H

4. When was the last time you brushed your teeth?

Refused (Go to Q3)

H

Y

Y

a.m.

M M

Y

p.m.

Date: |__|__| / |__|__| / |__|__|__|__|
M

M

D

D

Y

Time: |__|__| : |__|__|
H

5. Have you had cancer chemotherapy within the past 2 weeks?
Yes
No
Don’t know

H

M

Y

a.m.

M

Refused

Y

Y

p.m.

Part C: Buccal Cell Collection Results
1.
Collection Time:
|__|__| : |__|__|
H

H

M

M

a.m.

p.m.

2.

Number of Scrapers Used: ______

3.

Order of Scrapers for Collection:

4.

Time placed in shipping container: |__|__| : |__|__|

Right, Left, Right, Left, Both
H

H

M

M

a.m.

Other--specify:_____________
p.m.

Part D: Comments
 GO TO TOP OF FORM AND COMPLETE PART E BUCCAL CELL COLLECTION STATUS
Public reporting burden for this collection of information is estimated to average 3 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-XXXX). Do not return the completed form to this address.

Urine Data Collection Form
Respondent ID
Date Printed

DCN

OMB Control Number: 0925-XXXX
Expiration Date:

PATH Study

Urine Data Collection Form

Interviewer/Phlebotomist Administered
Part A: Administrative
5. Staff ID: Preprinted

Part E: Urine Collection Status
1. Collection Status (Mark one):
Collected (End)
Attempted, not collected
Not collected

6. Today’s Date:
|__|__|/|__|__|/|__|__|__|__|
M

M

D

D

Y

Y

Y

2. Reason Not Collected (Mark one main reason):
Respondent refused
No time
Respondent ill/emergency
Language issue
Cognitive disability
Defective/missing collection supplies
Physical limitations (Specify): ______________________
Other--specify: __________________________________

Y

7. Urine Collection:
Agreed
Not agreed (Go to Part E)
8. Urine Kit ID: (Go to Part B)
(Place Label Here)

Part B: Urine Collection Questions
1.
When was the last time you urinated?
Don’t know
Refused

Date: |__|__| / |__|__| / |__|__|__|__|
M

M

D

D

Y

Time: |__|__| : |__|__|
H

2.

When was the last time you had anything to eat
or drink other than water?
Don’t know
Refused

M

No

Don’t know

a.m.

M

M

D

D

Y

Time: |__|__| : |__|__|

Have you had cancer chemotherapy within the past 2 weeks?
Yes

M

Y

Y

p.m.

Date: |__|__| / |__|__| / |__|__|__|__|

H

3.

H

Y

Refused

H

M

M

Y

a.m.

Y

Y

p.m.

Part C: Urine Collection Results

(Place Label H ere)

1.

Specimen ID:

2.

Collection time:

3.

Time placed in shipping container: |__|__| : |__|__|

|__|__| : |__|__|
H

H

H

H

M

M

M

M

a.m.

p.m.

a.m.

p.m.

Part D: Comments

 GO TO TOP OF FORM AND COMPLETE PART E URINE COLLECTION STATUS
Public reporting burden for this collection of information is estimated to average 3 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-XXXX). Do not return the completed form to this address.