L-PVDOMICS STUDY

L-PVDOMICS STUDY FORMS/DATA TRANSMISSION FORMATS

TABLE OF CONTENTS – as of 08/26/2021

CENTER PARTICIPANT FORMS

L-PVD

Form #

Version

Date*

Participation

Level

Form Name

---

04/10/2016

L1, L2, L3

Participant Contact Information and Pre-Screening Sheet   (not entered into study database)

499

08/06/2020

L1

Screening for COVID-19 Prior to Enrollment

500

08/06/2020

L1, L2, L3

L-PVDOMICS Enrollment Form

501

08/06/2020

L1

L2 Enrollment Transition to L1 Enrollment

502

502C

08/25/2021

08/26/2021

L1, L2, L3

PVD Assessment Form

Comparator Additional PH Comorbidities

503

10/04/2019

L1, L2, L3

Non-PVD Comorbidity, Medical and Surgical History Form

505

01/14/2020

L1, L2

Exposure History Form

510

10/04/2019

L1, L2, L3

PH and Concomitant Medications Form

515

10/04/2019

L1, L2

Functional Class

520

10/04/2019

L1

Study Visit Vital Signs Form

521

11/07/2019

L1, L2

Female Reproductive History Form

531

10/04/2019

L1

Waist/Hip Measure Form

532

10/04/2019

L1, L2, L3

Height, Weight Form

533

11/18/2020

L1

6 Minute Walk Test (6MWT) Form

550

04/08/2020

L1

Sleep Study Initialization, Demo, Placement

551

04/17/2020

L1

Participant Sleep/Nocturnal Oximetry Questionnaire

Administrative Form

552

04/30/2020

L1

Sleep Study Download Transmit Form

555

03/01/2020

L1,L2,L3

Alternative Sleep Study Form

570

10/04/2019

L1, L2

Survey Instrument (SF-36v2) Form – English

(administrative form is attached to document)

570S

10/04/2019

L1, L2

SF-36v2 Questionnaire – Spanish

Administration Form

571

10/04/2019

L1, L2

Minnesota Living With Heart Failure® Questionnaire (MLHF) – English

Admin. Form for MLHF

571S

10/04/2019

L1, L2

Admin Form for MLHF Questionnaire – Spanish

Admin. Form for MLHF


572

10/04/2019

L1, L2

emPHasis-10 Quality of Life Form – English

Admin. Form for emPHasis

   

emPHasis-10 darker print version

572S

10/04/2019

L1, L2, L3

emPHasis-10 Questionnaire – Spanish

Admin. Form for emPHasis

590

09/11/2020

L1

COVID-19 2-Week Follow-up

 

 

 

 

600

06/26/2020

L1, L2, L3

Center CBC w Diff Results

601

06/26/2020

L1, L2, L3

Center Complete Metabolic Panel (CMP) Results

644

12/02/2019

L1, L2, L3

Locally Read ECG Results

650

10/04/2019

L1

Echocardiogram (ECHO) Transmittal Form

653

10/04/2019

L1, L2, L3

Center Transmittal of Chest CT Images and Report Form

671

10/04/2019

L1, L2, L3

Pulmonary Function Testing

680

03/03/2020

L1, L2, L3

Clinical Center Right Heart Catheterization (RHC)

689

02/28/2020

L1, L2, L3

Center Cycle Ergometer CPET

(Combined 290/291 and addendum)

800

03/30/2020

L1

Center OMICS Blood Collection  – Drawing Samples Form

801

10/04/2019

L1

Center OMICS Blood Collection  – Processing Samples Form

803

10/04/2019

L1

Ctr Blood Collection – Shipping of Frozen Cryovials and PAXgene® Tubes to Biorepository Form

805

10/04/2019

L1

Ctr Blood Collection  – Processing PAXgene® “Rest” Sample Form

820

10/04/2019

L1

Center Urine Collection Sample

821

10/04/2019

L1

Center Urine Collection Processing Sample

830

10/04/2019

L1

Center BTS System Specimen Storage Log

836

10/04/2019

L1

Center BTS System FROZEN Specimen Shipment Log

 

 

 

 

900

 

L1

6MWT Event Notification Form

901

 

L1

6MWT Detailed Adverse Events Form

 

DCC CORE Forms

553

05/13/2020

n/a

Sleep Core Receipt and QA Review

556

03/01/2020

n/a

Sleep Core Review of Alternative Sleep Study Form

262

05/14/2020

n/a

Core CT Scan Center Results Form

620-Data dictionary

12/20/2019

n/a

Clinical Chemistry Core Results Data Transmission

660-Data Dictionary

 

n/a

ICL Core Echocardiogram (ECHO) Results Data Transmission

856

10/04/2019

n/a

Core BTS FROZEN Specimen Received Log