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pdfForm Approved
OMB No. 0920‐xxxx
Exp. Date xx/xx/xxxx
(affix label here)
Patient ID
Number
Site
Sub-site
Sequential ID
SEARCH Specimen Collection Form
Before drawing blood or collecting urine specimens:
1. Have you had DKA in the last 4 weeks that resulted in hospitalization or had to be treated by IV fluids?
1
No
2 Yes (if YES, then do NOT draw blood AND do not collect urine specimens)
2. For females only: Are you currently pregnant?
1 No
2 Yes (if YES, do NOT draw blood AND do not collect urine specimens)
3 Unsure (if UNSURE, do NOT draw blood AND do not collect urine specimens)
3. For females only: Are you currently menstruating/having your period?
1
2
4.
No
Yes (if YES, do NOT collect urine)
For Cohort Visits and females only: Were you menstruating when you did your overnight urine collection?
1
2
No
Yes (if YES, do NOT send overnight urine sample and repeat overnight urine collection
when patient is not menstruating)
5. Have you taken any insulin in the last 4 hours? (This does NOT include basal insulin per insulin pump.)
1 Yes (if YES, ask which insulins were taken; mark by the appropriate list of insulins below)
2 No (if NO, go to question 6)
1
2
3
Detemir
Glargine
Humulin N
Lantus
Levemir
Novolin N
NPH
Humulin R
Humulin 50/50
Humulin 70/30
Novolin R
Novolin 70/30
Regular
Apidra
Glulisine
Humalog
Humalog mix 50/50
Humalog mix 75/25
Novolog
Novolog mix 70/30
(by injection or bolus
per pump)
Acceptable
AM
Time:
Hour
Minute
PM
NOT acceptable if taken within 4 hours
prior to fasting blood sample – Proceed
with blood draw and try to re-schedule a
fasting re-draw visit.
AM
Time:
Hour
Minute
PM
NOT acceptable if taken within 2 hours
prior to fasting blood sample – Proceed
with blood draw and try to re-schedule a
fasting re-draw visit.
Public reporting burden of this collection of information is estimated to average 20 minutes per response, including the time for reviewing instructions, searching
existing data sources, gathering and maintaining 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 CDC Reports Clearance Officer; 1600
Clifton Road NE, MS D‐74, Atlanta, Georgia 30333; ATTN: PRA (0920‐xxxx).
SEARCH 3 Registry and Cohort Studies - Specimen Collection Form - 11-01-10
Page 1 of 4
6. Have you taken any other diabetes medications in the last 8 hours?
1
Yes (if YES, ask which medications were taken and mark by the appropriate list of
2
No
medications below; then answer question 6a at the bottom of the page)
Other diabetes medications:
1
Acarbose
Actos
Avandament
Avandia
Glucophage
Glyset
Metformin
Miglitol
Precose
Pioglitazone
Rosiglitazone
Acceptable medications
Amaryl
Byetta
2
1
Chlorpropamide
DiaBeta
Diabinese
Exenatide
Glimepiride
Glipizide
Glucotrol
Glucovance
Glyburide
Glynase
Januvia
Liraglutide
Micronase
Nateglinide
Prandin
Pramlintide
Repaglinide
Sitagliptin
Starlix
Symlin
Tolazamide
Tolbutamide
Victoza
Time:
Hour
Minute
AM
PM
NOT acceptable if taken within 8 hours prior to
fasting blood sample
Proceed with blood draw and try to re-schedule
a fasting re-draw visit.
Other diabetes medications: (specify)
IF UNACCEPTABLE INSULIN OR ORAL MEDICATION TAKEN, PROCEED WITH BLOOD DRAW AND TRY TO
SCHEDULE A FASTING RE-DRAW VISIT.
6a.
If a re-draw visit is necessary, has Patient agreed? 1
SEARCH 3 Registry and Cohort Studies - Specimen Collection form 11-01-10
Yes
2
No
Page 2 of 4
7. Have you had anything to eat or drink in the last 8 hours?
1
Yes
7a. if YES, ask the Patient what they had
to eat or drink. Describe what they had to
eat or drink.
7b. if Patient consumed non-allowable food
AM PM
Time:
or drink, record most recent time
Hour
Minute
IF FASTING LESS THAN 8 HOURS, PROCEED WITH BLOOD DRAW AND TRY TO
SCHEDULE A FASTING RE-DRAW VISIT.
7c.
2
If a re-draw visit is necessary, has Patient agreed? 1 Yes
2
No
No
8. Glucose meter reading:
(May use drop from blood collected with venipuncture samples)
If glucose is > 300 mg/dl, perform urinary ketone check and record.
8a. Urine ketones:
1
Negative
2
3
Trace/small
Moderate
4
9. Were any of the following symptoms observed or reported by the Patient?
Large
1
5
Yes
(If YES, check all that apply):
1
Abdominal pain
1
Diaphoresis (excessive sweating)
1
Lightheadedness
1
Nausea and or vomiting
1
Seizure
1
Tremors or trembling
1
Loss of consciousness due to low blood glucose
1
Loss of consciousness due to phlebotomy (fainting)
1
Blood glucose is < 45 mg./dl.
1
Blood glucose is > 300 mg./dl. with moderate or large ketones
1
Blood glucose is > 500 mg./dl. with or without ketones
1
Other (specify):
Unable to obtain
2No
10. Comments?
1
2
Yes (if YES, describe) :
No comments
NOTE: Complete SEARCH Unanticipated Occurrence/Condition Reporting Form if
any of the below presents:
•
•
seizure
loss of consciousness due to low blood glucose
SEARCH 3 Registry and Cohort Studies - Specimen Collection form 11-01-10
Page 3 of 4
11. Specimen obtained
by:
(code)
12. Date specimen
obtained:
Month
Day
13. Time specimen
Year
AM / PM (check one)
collected:
Hour
Minute
Please instruct the Patient to take medication/insulin and provide a breakfast to the Patient.
FOR STUDY USE ONLY
Date Completed
Completed by
Month
Day
Year
Date Reviewed
Reviewer Code
Month
Day
Year
Date Entered
Month
Day
Year
SEARCH 3 Registry and Cohort Studies - Specimen Collection form 11-01-10
Data Entry
Code
Page 4 of 4
| File Type | application/pdf |
| File Title | Microsoft Word - 4a3_specimen collection |
| Author | stmoxley |
| File Modified | 2011-09-09 |
| File Created | 2011-09-09 |