Form 1 BIO-Biospecimen Collection

Public reporting burden for this collection of information is estimated to average 39 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 (0925-0584). Do not return the
completed form to this address.

OMB#: 0925-0584
Exp. xx/xx/xxxx

BIOSPECIMEN COLLECTION FROM
PARTICIPANT ID #:

LAB ID#

FORM CODE: BIO
VERSION: 1, 1/7/2014

0

Contact Occasion

2 SEQ #

0

1

Instructions: This form should be completed during the participant’s visit. Affix the participant ID label and the Lab ID
label above. Whenever numerical responses are required, enter the number so that the last digit appears in the rightmost
box. Enter leading zeroes where necessary to fill all boxes. Use a 24-hour clock for time (e.g. noon=12:00, 1pm=13:00)
A. Safety Questions:
1.

Have you ever had a radical mastectomy or other surgery where lymph nodes were removed from your armpits?
0

No

1

Yes If Yes, specify in Q15 and follow precautions per QxQ instructions
0

1

2.

Do you have any bleeding disorders?

3.

Have you ever had a graft or shunt for kidney dialysis?
0

No

1

Yes

No

Yes

If Yes, specify in Q15; follow precautions per QxQ instructions

If Yes, specify in Q15; exclude from OGTT and follow precautions per QxQ instructions

4. Confirm/ask per Safety Form: Has diabetes

0

1

No

Yes If Yes, exclude from OGTT; go to Q7
0

5. Have you had part of your stomach or intestines removed ?
6. Glucose meter reading
6a.

Yes

If Yes, exclude from OGTT; go to Q7

If above 150 mg/dL exclude from OGTT; if above 200 mg/dL also go to Q6a, 6b
0

Hyperglycemia symptoms

6b. Ketone dipstick

1

No

1

1

No

Yes If symptoms present refer for urgent care
2

Not Applicable

3

Negative

Positive If Positive refer for urgent care

B. Fasting Blood Collection Information:
7. On which day did you last eat or drink anything except water: today, yesterday, or the day before yesterday?
1
3
Today .......... 2 Yesterday
Before Yesterday
8.

:

And at what time was that?

If fasting is less than 8 hrs, exclude from OGTT
(24-hour)

h h : m m
C. Blood Collection:
9. Date of blood collection:
mm

/
/d d

/
/y y y y

10. Collection time:
0

11. Was fasting blood collected before the glucola/snack?

:
h h : m m

1

No

(24-hour)

Yes

12. Number of venipuncture attempts:
13. Any blood drawing incidents or problems? .................

0

No

1

Yes If Yes, specify in Q14 and/or Q15

14. Blood drawing incidents: Document problems with venipuncture in this table. Place an “X” in box(es) corresponding to the tubes in
which the blood drawing problem(s) occurred. If a problem other than those listed occurred, use Item 15.
Tube Number
1
2
3
4
5
6
7
8
a. Sample not drawn
b. Partial sample drawn
c. Tourniquet reapplied
d. Fist clenching
e. Needle movement
f. Participant reclining

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FORM CODE: BIO
VERSION: 1, 1/7/2014

PARTICIPANT ID NUMBER:

Contact
Occasion

0 2 SEQ #

0 1

15. If any other blood drawing problems not listed above (e.g., fasting status, etc.), describe incident or problem here:

16. Phlebotomist’s code number:
D. Blood Processing:

:

17. Time at which tubes 4 - 7 were centrifuged:
h h

: m m (24-hour)

:

18. Time at which tubes 1-2 were centrifuged:
h h

: m m (24-hour)

:

19. Time at which aliquot tray 1 vials were placed in freezer:
h h

: m m (24-hour)

20. Blood Processor’s code number:
0

21. Any blood processing incidents or problems?

No

1

Yes

If yes, specify in Q21 and/or Q22

22. Blood processing incidents: Document problems with the processing of specimens in this table. Place an “X” in box(es)
corresponding to tubes in which the processing problem(s) occurred. If a problem other than those listed occurred, use Item 23.
Tube Number
1
2
3
4
5
6
7
8
a. Broken tube
b. Sample re-centrifuged
c. Clotted
d. Hemolyzed
e. Lipemic
23. Comments on blood processing, urine collection/processing, and OGTT:

0

24. Was a post-glucola sample collected?:

No

1

Yes

:

25. Time glucola given:
h h

: m m

(24-hour)

:

26. Time of collection of post-glucola samples:
h h

: m m

(24-hour)

27. Blood Processor’s code number for post-glucose load samples:
E. Urine Sample
28. Was a urine sample collected?

0

29. Date of urine sample:

/

/
mm /d d

No

Yes

/y y y y

:

30. Time urine sample collected:

1

(24-hour)

h h : m m

:

31. Time urine sample was processed:
h h

: m m (24-hour)

32. Urine processor’s code #:

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