PVDOMICS STUDY FORMS and DATA TRANSMISSION FORMATS

TABLE OF CONTENTS – as of 02/08/2024

Form #

Version

Date*

Form Name

CENTER SPECIFIC FORMS

db_acct

09/18/2018

Data Entry Account Request Form

secure_acct

11/28/2016

Secure Transfer Account Request Form

Borg

--

Borg Dyspnea Scale

 

 

 

09

08/14/2020

Clinical Center Form

10

11/28/2016

Study Personnel Form

CENTER PARTICIPANT FORMS

---

04/10/2016

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

100

10/25/2017

Initial Enrollment Form (includes Inclusion and Exclusion Review questions)

102

08/03/2021

08/03/2021

PVD Assessment Form

102C-Comparators Only Assessment

103

10/30/2018

Non-PVD Comorbidity, Medical and Surgical History Form

104

04/04/2016

Demographics, Employment and Income Form

105

08/23/2018

Exposure History Form

106

11/09/2017

Thrombophilia History Form

107

06/17/2021

Review of Family History of Pulmonary Hypertension Form

110

06/23/2017

PH and Concomitant Medications Form

115

05/08/2019

Functional Class

 

 

 

120

06/23/2017

Study Visit Vital Signs Form

121

02/21/2018

Female Reproductive History Form

131

07/20/2017

Waist/Hip Measure Form

132

06/08/2017

Height, Weight, and Bioelectrical Impedance (BIA) Form

133

06/15/2018

6 Minute Walk Test (6MWT) Form

138

09/12/2018

Center Acknowledgment of Core Incidental Findings Form

 

 

 

150

01/10/2019

Clinical Center Participant Initial Sleep Form

151

151Admin

09/19/2016

11/29/2017

Participant Sleep Study Questionnaire

Administration Form for Sleep Study

152

01/10/2019

Clinical Center Sleep Download and Transmittal Form

155

04/04/2018

Clinical Center Alternative Sleep Study Report Transmission Form

 

 

 

170E

05/25/2016

Survey Instrument (SF-36v2) Form – English (administration form included at end of document)

170S

170Admin

07/12/2016

SF-36v2 Questionnaire – Spanish,

Administration Form for SF-36v2 Questionnaire - Spanish 

170S

170Admin

07/12/2016

SF-36v2 Questionnaire – Spanish,

Administration Form for SF-36v2 Questionnaire - Spanish

171E

04/05/2016

Minnesota Living With Heart Failure® Questionnaire (MLHF) – English (administration form included at end of document)

171S

171Admin

07/12/2016

MLHF Questionnaire Packet Form – Spanish,

Administration Form for MLHF Questionnaire

– Spanish

172E

04/08/2016

emPHasis-10 Quality of Life Form – English (administration form included at end of document)

        emPHasis-10 darker print version

172S

172Admin

08/10/2016

emPHasis-10 Questionnaire – Spanish,

Administration Form for emPHasis-10 Questionnaire – Spanish

185

10/01/2018

Participant Two-Week Event Assessment

187

01/09/2023

Annual Follow-up

 

 

 

200

08/22/2017

Center CBC w Diff Results

201

01/11/2018

Center Complete Metabolic Panel (CMP) Results

202

09/17/2019

Center Antinuclear Antibody (ANA) Results

203

06/23/2017

Center HIV Antigen/Antibody Screen Result

204

02/23/2018

Center Hepatitis Screen Result

205

06/23/2017

Center Prothrombin Time (PT) Results

206

06/23/2017

Center Pregnancy Test Results

207

11/10/2017

Center Arterial Blood Gases (ABG) Results

 

 

 

245

01/20/2017

Center Electrocardiogram (ECG) Data Transmittal Form

250

02/27/2019

Echocardiogram (ECHO) Transmittal Form

251

08/31/2017

Cardiac MRI Transmittal Form

252

02/22/2018

Center Chest CT Scan Data Transmittal Form

253

07/05/2017

Center Historical Chest CT Data Transmittal Form

254

07/09/2018

Center Ventilation/Perfusion (V/Q) Scan Report

 

 

 

270

10/27/2017

Pulmonary Function Testing

271

10/10/2017

Historical Pulmonary Function Testing

 

 

 

280

02/27/2019

Clinical Center Right Heart Catheterization (RHC)

 

 

 

290

 

290A

08/01/2018

 

05/24/2018

Center Cycle Ergometer Non-Invasive CPET Procedure Notes

 

Addendum to Center Cycle Ergometer Non-Invasive CPET Procedure Notes

291

 

291A

08/01/2018

 

05/24/2018

Center Cycle Ergometer Invasive CPET Procedure Notes

 

Addendum to Center Cycle Ergometer Invasive CPET Procedure Notes

 

 

 

300

02/16/2017

Center Blood Collection 1 – Drawing Samples Form

301

02/16/2017

Center Blood Collection 1 – Processing Samples Form

303

09/21/2017

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

304

03/03/2020

Center Blood Collection 2 – Drawing “Rest” Samples Form

305

05/23/2018

Center Blood Collection 2 – Processing PAXgene® “Rest” Sample Form

306

05/23/2018

Center Blood Collection 2 – Processing “Rest” Samples into Cryovials Form

307

05/23/2018

Center Blood Collection 2 – Drawing “Rest, Peak and Post” Samples Form

308

05/23/2018

Center Blood Collection 2 – Processing PAXgene® “Rest, Peak and Post” Sample Form

309

05/23/2018

Center Blood Collection 2 – Processing “Rest, Peak and Post” Samples into Cryovials

320

02/16/2017

Center Urine Collection 1 Sample

321

02/16/2017

Center Urine Collection 1 Processing Sample

330

11/01/2016

Center BTS System Specimen Storage Log

335

06/22/2017

Center BTS System ROOM TEMP Specimen Log and Shipment Form

336

11/01/2016

Center BTS System FROZEN Specimen Shipment Log

340

10/27/2016

Biorepository Emergency Supplies Request

 

 

 

 

400

03/22/2018

Event(s) Notification Form

401

07/10/2019

Detailed Adverse Events Form

402

10/27/2016

Event Information Sent to the DCC Form

410

03/07/2018

Center Request for Extension of Study Procedures

411

10/30/2018

Center Request for Exception

412

12/10/2019

Drop-Out

420

08/29/2018

Center Study Completion and Forever Missing Data

 

 

 

900

09/15/2021

COVID-19 Vaccination Details Form

Combined PVDOMICS and LPVDOMICS

 

 

 

DCC CORE FORMS ONLY

 

 

 

153

04/02/2018

Sleep Core Receipt and QA Review

154

02/08/2018

Sleep Core Incidental Findings

156

11/13/2018

Sleep Core Review of Alternative Sleep Study Form

220

12/20/2019

Clinical Chemistry Core Results Data Transmission

246

08/06/2018

CPC Electrocardiogram (ECG) Core Results Form

246A

02/08/2024

Electrocardiogram (ECG) Extra Measures

247

03/06/2018

CPC ECG Incidental Findings Form

256

01/12/2017

Core Review of Historical V/Q Scan Form

260

10/26/2017

ICL Core Echocardiogram (ECHO) Results Data Transmission

261

10/19/2018

ICL Core Cardiac MRI Imaging Results Data Transmission

262

05/14/2020

Lung Imaging Core (CT) Results

262A

03/03/2021

Lung Imaging PA Measures

262B

12/12/02023

CT Core CTEPH Extra Measures

263

03/12/2018

Lung Imaging Core (CT) Incidental Finding(s)

266

12/07/2017

Core Cardiac ECHO Incidental Finding(s)

267

12/07/2017

Core Cardiac MRI Incidental Finding(s)

283

08/02/2018

Core Right Heart Catheterization (RHC) Results

292

03/05/2021

CPC CPET Results

293

03/06/2018

CPC CPET Incidental Findings

294

10/01/2020

CPC CPET Results Subset

355

08/13/2017

Core BTS ROOM TEMPERATURE Specimen Received Log

356

01/24/2018

Core BTS FROZEN Specimen Received Log

357

07/26/2017

Core BTS Room Temperature Processing

358

07/12/2017

Core Room Temperature Log

360

08/22/2019

Core BTS Destroyed Specimen Log

361

02/25/2020

Core BTS Core Shipment Log

 

 

 

COMMITTEE REVIEW FORMS

700

02/25/2019

Adjudication Committee Reviewer Form

701

11/08/2018

Adjudication Committee Final Classification