L-PVDOMICS STUDY

L-PVDOMICS STUDY MANUAL of OPERATIONS

TABLE OF CONTENTS – as of 02/16/2021

Chapter #

Manual of Operations Chapters

Version

Date

Chapter 201

L-PVDOMICS Study Overview

 

Chapter 204

Enrollment

Ÿ  Consent Templates for Center Customization:

•       Consent Template

•      Biobank Consent Template

Chapter 6

Forms Completion, Data Entry and Computing – See also PVDOMICS Parent Study

New Secure Portal Instructions

Appendix 1: Secure Document Transfer

 

 

Chapter 231

  Level 1 Participant Visits During COVID-19 Pandemic

 

Chapter 232

Transferring Level 2 Enrollees Into Level 1 Participants (L2-to-L1)

 

Chapter 233

Biorepository Clinical Center Blood Collection Overview And Blood Drawing Procedures - Level 1 only

 

Chapter 234

Biorepository Clinical Center Blood Processing and Shipping - Level 1 only

Appendix 234.1: PVDOMICS OMICS Blood Collection 1: Processing, Aliquoting, Recording and Storing of Biospecimens

 

Chapter 235

Biorepository Core Urine Specimens Collection, Processing and Shipping - Level 1 only

Appendix 235.1: Template for Female Urine Collection Instructions

Appendix 235.2: Template for Male Urine Collection Instructions

Chapter 239

Six-Minute Walk Test (6MWT)

·         Adverse event reporting for 6MWT

Chapter 241

Clinical Center Sleep Study Processing and Review

NoxT3 Oximetry Only

 

Appendix 1: General Participant Instructions

Appendix 2: PAP Participant Instructions

Appendix 3: Supplemental Oxygen Participant Instructions

Appendix 4: Nox T3 Oximetry Only

Appendix 5: Nox T3 Cleaning and Safety Precautions

 

Nox T3 Ordering Supplies Information

02/16/2021

Chapter 242

Sleep Study Core

Chapter 260

ECHO Testing Overview and General Information

Clinical Echocardiography Sonographer Guide -  Additional Variables to be captured

10/06/2020

Chapter 280

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