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PVDOMICS
STUDY FORMS and DATA TRANSMISSION FORMATS TABLE
OF CONTENTS – as of 02/08/2024 |
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Form # |
Version Date* |
Form
Name |
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CENTER
SPECIFIC FORMS |
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09/18/2018 |
Data Entry Account Request Form |
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11/28/2016 |
Secure Transfer Account Request
Form |
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Borg Dyspnea Scale |
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08/14/2020 |
Clinical Center
Form |
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11/28/2016 |
Study Personnel
Form |
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CENTER PARTICIPANT FORMS |
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04/10/2016 |
Participant Contact Information and Pre-Screening Sheet (not entered into study database) |
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10/25/2017 |
Initial
Enrollment Form (includes Inclusion and
Exclusion Review questions) |
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08/03/2021 08/03/2021 |
PVD
Assessment Form |
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10/30/2018 |
Non-PVD
Comorbidity, Medical and Surgical History Form |
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04/04/2016 |
Demographics,
Employment and Income Form |
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08/23/2018 |
Exposure
History Form |
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11/09/2017 |
Thrombophilia
History Form |
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06/17/2021 |
Review
of Family History of Pulmonary Hypertension Form |
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06/23/2017 |
PH
and Concomitant Medications Form |
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05/08/2019 |
Functional
Class |
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06/23/2017 |
Study
Visit Vital Signs Form |
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02/21/2018 |
Female
Reproductive History Form |
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07/20/2017 |
Waist/Hip
Measure Form |
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06/08/2017 |
Height,
Weight, and Bioelectrical Impedance (BIA) Form |
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06/15/2018 |
6
Minute Walk Test (6MWT) Form |
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09/12/2018 |
Center
Acknowledgment of Core Incidental Findings Form |
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01/10/2019 |
Clinical Center Participant Initial Sleep
Form |
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09/19/2016 11/29/2017 |
Participant Sleep Study Questionnaire Administration Form for Sleep Study |
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01/10/2019 |
Clinical Center Sleep Download and
Transmittal Form |
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04/04/2018 |
Clinical
Center Alternative Sleep Study Report Transmission Form |
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05/25/2016 |
Survey
Instrument (SF-36v2) Form – English (administration form included at end of
document) |
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07/12/2016 |
SF-36v2
Questionnaire – Spanish, Administration
Form for SF-36v2 Questionnaire - Spanish
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07/12/2016 |
SF-36v2
Questionnaire – Spanish, Administration
Form for SF-36v2 Questionnaire - Spanish |
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04/05/2016 |
Minnesota
Living With Heart Failure® Questionnaire (MLHF) – English (administration
form included at end of document) |
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07/12/2016 |
MLHF
Questionnaire Packet Form – Spanish, Administration
Form for MLHF Questionnaire –
Spanish |
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04/08/2016 |
emPHasis-10
Quality of Life Form – English (administration form included at end of
document) |
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08/10/2016 |
emPHasis-10
Questionnaire – Spanish, Administration
Form for emPHasis-10 Questionnaire – Spanish |
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10/01/2018 |
Participant
Two-Week Event Assessment |
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01/09/2023 |
Annual
Follow-up |
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08/22/2017 |
Center
CBC w Diff Results |
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01/11/2018 |
Center
Complete Metabolic Panel (CMP) Results |
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09/17/2019 |
Center
Antinuclear Antibody (ANA) Results |
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06/23/2017 |
Center
HIV Antigen/Antibody Screen Result |
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02/23/2018 |
Center
Hepatitis Screen Result |
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06/23/2017 |
Center
Prothrombin Time (PT) Results |
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06/23/2017 |
Center
Pregnancy Test Results |
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11/10/2017 |
Center Arterial Blood Gases (ABG)
Results |
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01/20/2017 |
Center
Electrocardiogram (ECG) Data
Transmittal Form |
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02/27/2019 |
Echocardiogram
(ECHO) Transmittal Form |
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08/31/2017 |
Cardiac MRI
Transmittal Form |
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02/22/2018 |
Center Chest CT Scan Data Transmittal Form |
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07/05/2017 |
Center Historical Chest CT Data
Transmittal Form |
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07/09/2018 |
Center Ventilation/Perfusion (V/Q) Scan
Report |
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10/27/2017 |
Pulmonary Function Testing |
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10/10/2017 |
Historical
Pulmonary Function Testing |
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02/27/2019 |
Clinical
Center Right Heart Catheterization (RHC) |
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08/01/2018 05/24/2018 |
Center
Cycle Ergometer Non-Invasive CPET Procedure Notes Addendum
to Center Cycle Ergometer Non-Invasive CPET Procedure Notes |
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08/01/2018 05/24/2018 |
Center
Cycle Ergometer Invasive CPET Procedure Notes Addendum
to Center Cycle Ergometer Invasive CPET Procedure Notes |
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02/16/2017 |
Center
Blood Collection 1 – Drawing Samples Form |
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02/16/2017 |
Center
Blood Collection 1 – Processing Samples Form |
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09/21/2017 |
Center
Blood Collection – Shipping of Frozen Cryovials and PAXgene® Tubes to Biorepository Form |
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03/03/2020 |
Center
Blood Collection 2 – Drawing “Rest” Samples Form |
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05/23/2018 |
Center
Blood Collection 2 – Processing PAXgene® “Rest” Sample Form |
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05/23/2018 |
Center
Blood Collection 2 – Processing “Rest” Samples into Cryovials Form |
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05/23/2018 |
Center
Blood Collection 2 – Drawing “Rest, Peak and Post” Samples Form |
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05/23/2018 |
Center
Blood Collection 2 – Processing PAXgene® “Rest, Peak and Post” Sample Form |
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05/23/2018 |
Center
Blood Collection 2 – Processing “Rest, Peak and Post” Samples into Cryovials |
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02/16/2017 |
Center
Urine Collection 1 Sample |
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02/16/2017 |
Center
Urine Collection 1 Processing Sample |
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11/01/2016 |
Center
BTS System Specimen Storage Log |
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06/22/2017 |
Center
BTS System ROOM TEMP Specimen Log and Shipment Form |
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11/01/2016 |
Center
BTS System FROZEN Specimen Shipment Log |
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10/27/2016 |
Biorepository
Emergency Supplies Request |
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03/22/2018 |
Event(s)
Notification Form |
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07/10/2019 |
Detailed Adverse Events Form |
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10/27/2016 |
Event
Information Sent to the DCC Form |
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03/07/2018 |
Center Request for Extension of
Study Procedures |
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10/30/2018 |
Center Request for Exception |
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12/10/2019 |
Drop-Out |
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08/29/2018 |
Center
Study Completion and Forever Missing Data |
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09/15/2021 |
COVID-19
Vaccination Details Form Combined
PVDOMICS and LPVDOMICS |
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DCC CORE FORMS ONLY |
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04/02/2018 |
Sleep Core Receipt and QA Review |
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02/08/2018 |
Sleep Core Incidental Findings |
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11/13/2018 |
Sleep
Core Review of Alternative Sleep Study Form |
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12/20/2019 |
Clinical
Chemistry Core Results Data Transmission |
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08/06/2018 |
CPC Electrocardiogram (ECG) Core Results Form |
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02/08/2024 |
Electrocardiogram (ECG) Extra Measures |
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03/06/2018 |
CPC ECG Incidental Findings Form |
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01/12/2017 |
Core Review
of Historical V/Q Scan Form |
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10/26/2017 |
ICL Core
Echocardiogram (ECHO) Results Data Transmission |
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10/19/2018 |
ICL Core
Cardiac MRI Imaging Results Data Transmission |
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05/14/2020 |
Lung Imaging Core (CT) Results |
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03/03/2021 |
Lung Imaging PA Measures |
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12/12/02023 |
CT Core CTEPH Extra Measures |
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03/12/2018 |
Lung Imaging
Core (CT) Incidental Finding(s) |
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12/07/2017 |
Core Cardiac
ECHO Incidental Finding(s) |
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12/07/2017 |
Core Cardiac
MRI Incidental Finding(s) |
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08/02/2018 |
Core Right Heart Catheterization (RHC)
Results |
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03/05/2021 |
CPC
CPET Results |
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03/06/2018 |
CPC
CPET Incidental Findings |
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10/01/2020 |
CPC
CPET Results Subset |
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08/13/2017 |
Core
BTS ROOM TEMPERATURE Specimen Received Log |
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01/24/2018 |
Core
BTS FROZEN Specimen Received Log |
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07/26/2017 |
Core
BTS Room Temperature Processing |
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07/12/2017 |
Core
Room Temperature Log |
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08/22/2019 |
Core
BTS Destroyed Specimen Log |
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02/25/2020 |
Core
BTS Core Shipment Log |
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COMMITTEE REVIEW
FORMS |
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02/25/2019 |
Adjudication
Committee Reviewer Form |
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11/08/2018 |
Adjudication Committee Final
Classification |
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