Multicenter International Cross-Sectional Evaluation of Pulmonary Alveolar Proteinosis (MICEPAP) Trial

dbGaP Study Accession: phs001309.v1.p1

Subject Sample Telemetry Report (SSTR)

Study version history

Study
phs001309.v1.p1

Document Name and Accession

Document Name: RLD 5706 Forms (Jun 2007)
Document Accession: phd007613.1

Document

View pdf copy of original document

RLD 5706 Forms (Jun 2007)

Version Date: 25Jun07

RDCRN Protocol #5706 RLDC MICEPAP Study

[Note: Content is obscured in the pdf version which was overlapped by text boxes in the original Word document. All text was captured and presented below.]

RDN Participant ID:	Participant Name: First
Local Subject ID:	Middle:
Date of Evaluation: (dd mmm yyyy)	Last:

Site ID:

Name of person completing form:

Initial data entry completed using:

Paper case report formOnline data entry form

1. Diagnosis and Key Dates

Clinical form of PAP present:

AutoimmuneSecondaryCongenitalUnclassified

Date symptoms started: (dd/mm/yyyy)

Date of first visit to a doctor about this problem: (dd/mm/yyyy)

Date a definitive diagnosis of PAP was made: (dd/mm/yyyy)

Date serum was collected for this study: (dd/mm/yyyy)

Date serum shipped for evaluation in this study: (dd/mm/yyyy)

Date of first treatment for PAP: (dd/mm/yyyy)

2. Demographics

Date of birth: (dd/mm/yyyy)

Gender:

MaleFemaleUnknownNot Reported

Ethnicity (select one):

Hispanic or Latino
Not Hispanic or Latino
Unknown
Not reported

3. Tobacco Exposure

UnknownNot Done

Never smoker:

YesNo

Current smoker:

YesNo

Ex-smoker:

YesNo

If ex-smoker, when did smoking stop: (dd/mm/yyyy)

If current or ex-smoker, indicated smoking type:

CigarettesCigarsPipe

Duration of smoking: (number of years)

Amount of smoking: (number of packs per day)

Comments:

4. Occupational Exposure

Occupation(s):

Duration of Exposure: (years)

Comments:

5. Medical Illnesses

Other Medical History:

7. Medical Illnesses in Family Members

Do any of the participant’s family members have the following:

PAP?

YesNoUnknown

If yes, complete table below:

Relationship of affected person*	Clinical form of PAP
	AutoimmuneSecondaryCongenitalUnclassified
	AutoimmuneSecondaryCongenitalUnclassified
	AutoimmuneSecondaryCongenitalUnclassified

Autoimmune disease?

YesNoUnknown

If yes, complete table below:

Relationship of affected person*	Type of autoimmune disease:

Other disease?

YesNoUnknown

If yes, complete table below:

Relationship of affected person*	Type of disease:

*Relationship types:
(Mother, Father, Maternal Grandmother, Maternal Grandfather, Paternal Grandmother, Paternal Grandfather, Daughter, Son, Sister, Brother, Maternal Aunt, Maternal Uncle, Paternal Aunt, Paternal Uncle, Other Biological Relative)

8. Clinical Presentation

Was any other treatment initiated before PAP was diagnosed?

YesNoUnknown

If yes, indicate what treatment (generic) was started: (RxNorm browser)

10. Diagnosis

At the time of diagnosis of PAP, was serum GM-CSF autoantibody measured?

YesNoUnknown

Result: (μg/ml) (titer (for serial dilution method))

Was the GM-CSF autoantibody titer used to determine the diagnosis?

YesNoUnknown

9. Infection

Has any serious infection been identified since the time of diagnosis?

YesNoUnknown

Other location (describe / comments): location = SNOMED browser: body structure (body structure); comments field ok to keep.

Comments:

10. Treatment

11. Serum collection

12. Investigator or designated individual completing this Case Report Form.

Name:

Date completed: (dd/mm/yyyy)

Signature: