ZIRP: Pregnant Woman Screening Form

Attachment C1

Form Approved

OMB No. 0920-XXX

Exp. Date XX/XX/20XX

Today’s date: _____/______/________

MM DD YYYY

ZIKV RNA Persistence (ZIRP): Pregnant Woman Screening Form

Clinic Information	Patient Information
Clinic name: _____________________________	Last name: _____________________________
Municipality*:_____________________________	First name: _____________________________
Study site # (if applicable):___________________	Date of Birth (mm/dd/yyyy): _______________

1. Inclusion Criteria

Is the patient RT-PCR positive* for ZIKV on blood or urine?	□1Yes □0 No
Is the patient 15 years of age or older?	□1Yes □0 No
Does the patient speak English or Spanish?	□1Yes □0 No
Is the patient able to return every 2 weeks for specimen collection?	□1Yes □0 No
Is the patient willing to consider enrolling their infant into the study at birth?	□1Yes □0 No

If any of the above inclusion criteria is answered “no” the patient is NOT eligible for study

2. Exclusion Criteria

Is the patient not physically or psychologically able to participate based on clinical judgment?	□1Yes □0 No
Is the patient’s pregnancy ectopic or molar?	□1Yes □0 No

If 1 or more of the above exclusion criteria is answered “yes” the patient is NOT eligible for study

3. Eligibility Determination

The patient is eligible for the study. (All answers to inclusion criteria questions are Yes AND all answers to exclusion criteria are No.)

□₁Yes □₀ No

4. Informed Consent

Did the patient sign informed consent for participation? □₁Yes □₀ No

4.1 If yes,

4.1a Date when informed consent was signed (mm/dd/yyyy): ______________________

4.1b Was the patient given a copy of the consent? □₁Yes □₀ No

4.2 If no,

4.2a. Why not? ______________________________________________

5. Enrollment

5.1 Was the patient enrolled? □₁Yes □₀ No

5.2 Patient identifier number: _______ ____ ____ _____ 0

(Site number: 1, 2…) (Patient number: 001,002 etc)

Public reporting burden of this collection of information is estimated to average 2 minutes, 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 CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74,  Atlanta, Georgia 30333; ATTN:  PRA (0920-1189).