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L-PVDOMICS STUDY L-PVDOMICS
STUDY FORMS/DATA TRANSMISSION FORMATS TABLE OF CONTENTS – as of 08/26/2021 |
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CENTER
PARTICIPANT FORMS |
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L-PVD Form
# |
Version Date* |
Participation Level |
Form
Name |
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04/10/2016 |
L1, L2, L3 |
Participant Contact Information and Pre-Screening Sheet (not entered into study database) |
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08/06/2020 |
L1 |
Screening for
COVID-19 Prior to Enrollment |
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08/06/2020 |
L1, L2, L3 |
L-PVDOMICS
Enrollment Form |
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08/06/2020 |
L1 |
L2 Enrollment
Transition to L1 Enrollment |
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08/25/2021 08/26/2021 |
L1,
L2, L3 |
PVD Assessment Form Comparator Additional
PH Comorbidities |
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10/04/2019 |
L1,
L2, L3 |
Non-PVD
Comorbidity, Medical and Surgical History Form |
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01/14/2020 |
L1,
L2 |
Exposure History
Form |
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10/04/2019 |
L1,
L2, L3 |
PH and
Concomitant Medications Form |
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10/04/2019 |
L1,
L2 |
Functional Class |
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10/04/2019 |
L1 |
Study Visit
Vital Signs Form |
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11/07/2019 |
L1,
L2 |
Female Reproductive
History Form |
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10/04/2019 |
L1 |
Waist/Hip
Measure Form |
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10/04/2019 |
L1, L2, L3 |
Height, Weight
Form |
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11/18/2020 |
L1 |
6 Minute Walk Test
(6MWT) Form |
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04/08/2020 |
L1 |
Sleep Study
Initialization, Demo, Placement |
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04/17/2020 |
L1 |
Participant
Sleep/Nocturnal Oximetry Questionnaire |
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04/30/2020 |
L1 |
Sleep Study
Download Transmit Form |
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03/01/2020 |
L1,L2,L3 |
Alternative
Sleep Study Form |
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10/04/2019 |
L1, L2 |
Survey
Instrument (SF-36v2) Form – English (administrative form is attached to document) |
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10/04/2019 |
L1,
L2 |
SF-36v2
Questionnaire – Spanish |
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10/04/2019 |
L1,
L2 |
Minnesota Living
With Heart Failure® Questionnaire (MLHF) – English |
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10/04/2019 |
L1,
L2 |
Admin Form for
MLHF Questionnaire – Spanish |
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10/04/2019 |
L1,
L2 |
emPHasis-10
Quality of Life Form – English |
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10/04/2019 |
L1,
L2, L3 |
emPHasis-10
Questionnaire – Spanish |
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09/11/2020 |
L1 |
COVID-19 2-Week
Follow-up |
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06/26/2020 |
L1, L2, L3 |
Center CBC w
Diff Results |
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06/26/2020 |
L1, L2, L3 |
Center Complete Metabolic
Panel (CMP) Results |
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12/02/2019 |
L1, L2, L3 |
Locally Read ECG
Results |
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10/04/2019 |
L1 |
Echocardiogram (ECHO) Transmittal
Form |
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10/04/2019 |
L1, L2, L3 |
Center Transmittal of Chest CT Images and Report Form |
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10/04/2019 |
L1, L2, L3 |
Pulmonary Function Testing |
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03/03/2020 |
L1, L2, L3 |
Clinical Center Right Heart Catheterization
(RHC) |
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02/28/2020 |
L1, L2, L3 |
Center Cycle Ergometer CPET (Combined 290/291 and addendum) |
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03/30/2020 |
L1 |
Center OMICS
Blood Collection – Drawing Samples
Form |
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10/04/2019 |
L1 |
Center OMICS
Blood Collection – Processing Samples
Form |
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10/04/2019 |
L1 |
Ctr Blood
Collection – Shipping of Frozen Cryovials and PAXgene® Tubes to Biorepository Form |
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10/04/2019 |
L1 |
Ctr Blood
Collection – Processing PAXgene®
“Rest” Sample Form |
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10/04/2019 |
L1 |
Center Urine
Collection Sample |
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10/04/2019 |
L1 |
Center Urine
Collection Processing Sample |
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10/04/2019 |
L1 |
Center BTS
System Specimen Storage Log |
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10/04/2019 |
L1 |
Center BTS
System FROZEN Specimen Shipment Log |
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900 |
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L1 |
6MWT Event Notification Form |
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901 |
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L1 |
6MWT
Detailed Adverse Events Form |
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DCC CORE Forms |
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05/13/2020 |
n/a |
Sleep Core Receipt and QA Review |
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03/01/2020 |
n/a |
Sleep Core Review
of Alternative Sleep Study Form |
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05/14/2020 |
n/a |
Core CT Scan Center Results Form |
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12/20/2019 |
n/a |
Clinical Chemistry
Core Results Data Transmission |
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n/a |
ICL Core Echocardiogram (ECHO)
Results Data Transmission |
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10/04/2019 |
n/a |
Core BTS FROZEN
Specimen Received Log |
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