PVDOMICS MANUAL OF OPERATIONS TABLE OF CONTENTS – as of 05/04/2023
Chapter #	Manual of Operations Chapters	Version Date
Chapter 1	Overview and Structure of Manual of Operations
Chapter 2	Study Committees and Responsibilities	04/10/2016
Chapter 3	Clinical Site Set-up and Management Items to have on hand when study starts
Chapter 4	General Recruitment Issues and Strategies Ÿ Consent Templates for Center Customization: • Main/Comparator Groups Consent Template • Healthy Volunteers Consent Template • Biobank Consent Template • Genetics Discussion: Script for PH/Comparator and Control Groups Webinar • Documenting reasons for not approaching participants • Documenting reasons why participant did not consent	11/02/2016
Chapter 5	Adjudication and Recruitment Committee • WHO Group Classification • Recruitment • Process • Appendix 1-Main/Comparator WHO Group Classification	11/05/2016
Chapter 6	Forms Completion, Data Entry and Computing Appendix A: Installing Java on PC Secure Portal Set-up Instructions Secure Document Transfer	11/28/2017 05/04/2018 11/03/2017
Chapter 7	Reporting of Incidental Findings	05/17/2016
Chapter 9	Quality Control and Site Monitoring	01/19/2017
Chapter 10	Protocol Changes	05/24/2016
Chapter 11	Publications and Presentations Policy Publications and Guidelines Addendum Appendix 11.1: Signature Page for Publications and Presentations Policy	05/05/2016 05/04/2023
Chapter 12	Ancillary Studies Policy	02/25/2016
Chapter 19	Study Closeout/Archiving
Chapter 30	Participant Study Visits	03/03/2017
Chapter 31	Clinical Center Local Labs and Data Reporting	10/19/2016
Chapter 32	HRQOL Questionnaires • SF-36 • Minnesota Living with Heart Failure (MLHF) Questionnaire • EmPHasis-10	06/02/2016
Chapter 33	Biorepository Clinical Center Blood Collection Overview And Blood Drawing Procedures	05/23/2018
Chapter 34	Biorepository Clinical Center Blood Processing and Shipping Appendix 34.1: PVDOMICS OMICS Blood Collection 1: Processing, Aliquoting, Recording and Storing of Biospecimens Appendix 34.2: PVDOMICS OMICS Blood Collection 2: Processing, Aliquoting, Recording and Storing of Biospecimens Appendix 34.3: PVDOMICS OMICS Blood Collection: Healthy Controls Processing, Aliquoting, Recording and Storing of Biospecimens	05/23/2018 01/26/2017 04/11/2017 04/11/2017
Chapter 35	Biorepository Core Urine Specimens Collection, Processing and Shipping Appendix 35.1: Template for Female Urine Collection Instructions Appendix 35.2: Template for Male Urine Collection Instructions	09/21/2017
Chapter 36	Waist-to-Hip Circumference Measurements	10/25/2016
Chapter 37	Bioelectrical Impedance (BIA) Measurements Appendix 1-Tanita SC-240 Body Composition Analyzer	01/14/2017
Chapter 38	Blood Pressure and Vital Signs Measurements	10/13/2016
Chapter 39	Six-Minute Walk Test Summary Sheet of Recent Changes	06/15/2018 06/15/2018
Chapter 40	Electrocardiogram (ECG)	01/26/2017
Chapter 41	Clinical Center Sleep Study Processing and Review Appendix 1: General Participant Instructions Appendix 2: PAP Participant Instructions Appendix 3: Supplemental Oxygen Participant Instructions Nox T3 Ordering Supplies Information	02/03/2017 (App1-01/17/2017 App2 & 3: 10/12/16) 11/30/2017
Chapter 42	Sleep Study Core	08/31/2016
Chapter 43	Arterial Blood Gases	01/25/2016
Chapter 48	Adverse Events and Serious Adverse Events Reporting	12/14/2016
Chapter 50	Pulmonary Function Testing Overview Ÿ PF Lab Exam	10/12/2016
Chapter 51	Clinical Centers PFT-Spirometry	10/12/2016
Chapter 52	Clinical Center PFT-Lung Volumes Plethysmography (Body Box)	10/12/2016
Chapter 53	Clinical Center PFT-Single-Breath Carbon Monoxide Diffusing Capacity (DLCO)	10/05/2017
Chapter 55	Lung Physiology Core PFT QC Parameters	10/12/2016
Chapter 60	ECHO Testing Overview and General Information	03/02/2017
Chapter 70	Cardiac MRI Testing Overview and General Information • CMR Acquisition Reference Guide	01/25/2017
Chapter 80	Clinical Center Chest CT Imaging: Ctr 11 Brigham & Women’s Scanner Specifications Ctr 21 Columbia Scanner Specifications Ctr 22 Cornell Weill Scanner Specifications Ctr 31 Johns Hopkins Scanner Specifications Ctr 41 Mayo Clinic Scanner Specifications Ctr 51 Univ. of Arizona Scanner Specifications Ctr 61 Vanderbilt Scanner Specifications	11/03/2016 07/01/2019
Chapter 81	Lung Imaging Core Processing and Review	08/17/2016
Chapter 90	Ventilation/Perfusion (VQ) Scan	06/27/2017
Chapter 100	Clinical Center Right Heart Catheterization (RHC)	05/09/2018
Chapter 101	Clinical Center RHC Data Documentation and Transfer	01/31/2017
Chapter 110	Clinical Center Non-Invasive Cardiopulmonary Exercise Test (CPET) Appendix 1 Modified Borg Scale Appendix 2 Ramp Protocol Selection Appendix 3 Non-Invasive CPET Worksheet Appendix 4 Goldman Specific Activity Scale Appendix 5 CPET Calculations	06/13/2018
Chapter 111	Clinical Center Invasive Cardiopulmonary Exercise Test (iCPET)	06/13/2018