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responsibilities | 10 NOV 2021 |\n| 1.3 | Additional detail regarding statistical considerations | 07 DEC 2021 |\n| 1.4 | General editing for clarity | 09 JAN 2022 |\n| 2.0 | Autopsy protocol submitted to OSMB for final approval | 07 FEB 2022 |\n\n\n| Principal Investigators Clinical Science Core | Stuart Katz, MD MS\u003Cbr>NYU Grossman School of Medicine Leon H. Charney Division of Cardiology 530 First Avenue, Skirball 9R New York, NY 10016\u003Cbr>Leora Horwitz, MD\u003Cbr>NYU Grossman School of Medicine Department of Population Health Division of Healthcare Delivery Science 227 East 30th Street\u003Cbr>New York, NY 10016\u003Cbr>Andrea B. Troxel, ScD\u003Cbr>NYU Grossman School of Medicine Department of Population Health Division of Biostatistics\u003Cbr>180 Madison Avenue, Suite 5-55 New York, NY 10016 |\n| --- | --- |\n| Contact Principal Investigator Data Resource Core | Andrea Foulkes, ScD\u003Cbr>Mass General Hospital\u003Cbr>Harvard Medical School Department of Medicine 50 Staniford Street, Suite 560\u003Cbr>Boston, MA 02114\u003Cbr>[afoulkes@mgh.harvard.edu](afoulkes@mgh.harvard.edu) |\n| Protocol Biostatistician | Marie-Abele Bind, PhD\u003Cbr>Mass General Hospital\u003Cbr>Harvard Medical School Department of Medicine 50 Staniford Street, Suite 560\u003Cbr>Boston, MA 02114\u003Cbr>[mbind@mgh.harvard.edu](mbind@mgh.harvard.edu) |\n| NYU sIRB study number | Not applicable |\n\n\n| AE | Adverse Event/Adverse Experience |\n| --- | --- |\n| BMI | Body mass index |\n| CAP | College of American Pathologists |\n| CFR | Code of Federal Regulations |\n| COVID-19 | Coronavirus Disease 2019 |\n| CRF | Case Report Form |\n| DHHS | Department of Health and Human Services |\n| DSMB | Data and Safety Monitoring Board |\n| EHD | Electronic Health Database |\n| EHR | Electronic Health Record |\n| FAD | Final Anatomic Diagnosis |\n| GCP | Good Clinical Practice |\n| HIPAA | Health Insurance Portability and Accountability Act of 1996 |\n| ICF | Informed Consent Form |\n| ICH | International Conference on Harmonisation |\n| ICMJE | International Committee of Medical Journal Editors |\n| IRB | Institutional Review Board |\n| N | Number (typically refers to participants) |\n| NIH | National Institutes of Health |\n| OHRP | Office for Human Research Protections |\n| OHSR | Office of Human Subjects Research |\n| OSMB | Observational Study Monitoring Board |\n| PASC | Post-Acute Sequelae of COVID-19 |\n| PI | Principal Investigator |\n| REDCap | Research Electronic Data Capture |\n| SOP | Standard Operating Procedure |\n| US | United States |\n| WHO | World Health Organization |\n\n\n| Title | NIH RECOVER: A Multi-Site Pathology Study of Post-Acute Sequelae of SARS-CoV-2 Infection |\n| --- | --- |\n| Short Title | NIH RECOVER Tissue Pathology: Understanding the LongTerm Impact of COVID |\n| Primary Objectives | Aim 1. Characterize the prevalence and types of organ injury/disease, pathological features, and distinct phenotypesin decedents with acute SARS-CoV-2 infection (dying 15-30 days after infection) , and in decedents with prior SARS-CoV- 2 infection (dying >30 days after infection or > 30 days after hospital discharge) with and without PASC.\u003Cbr>Aim 2. Characterize the association of pathological findings with clinical measures of disease severity and associated risk factors in decedents with prior SARS-CoV-2 infection (dying > 30 days after SARS-CoV-2 infection or > 30 days after hospital discharge) with and without PASC.\u003Cbr>2a. Characterize the association of COVID-19 disease severity and treatment with pathological findings in decedents with prior SARS-CoV-2 infection with and without PASC .\u003Cbr>2b. Determine whether pre-infection and peri-infection risk and resiliency factors (e.g. , demographic, biological factors, and preexisting clinical comorbidities) are associated with pathological findings in decedents with prior SARS-CoV-2 infectio","cbCaieVOMFIRDPFu","https://ap.wps.com/l/cbCaieVOMFIRDPFu","pdf",1157425,47,"English","# Revision History\n## Version milestones and revision summaries\n# Protocol Stakeholders and Contacts\n## Principal investigators and study roles\n# Abbreviations and Definitions\n## Technical terms used in the protocol\n# Study Title and Objectives\n## Primary objectives and aim structure\n## Aim 2a-2b and Aim 3-4 focus areas","[{\"question\":\"What does Autopsy Protocol v2.0 include?\",\"answer\":\"It includes a structured revision history, listed principal investigators and contact roles, a glossary of protocol abbreviations, and the study title with detailed primary objectives and aims.\"},{\"question\":\"How are the revisions tracked across versions?\",\"answer\":\"The document provides a version table showing status or summary of changes and the version date for each release, including the final approval submission for version 2.0.\"},{\"question\":\"What are the main research objectives of the NIH RECOVER tissue pathology study?\",\"answer\":\"Objectives cover characterizing organ injury and pathological features in decedents with acute versus prior SARS-CoV-2 infection, associating pathology with clinical severity and risk factors, defining mechanisms via molecular investigation, and establishing multi-center tissue and brain imaging biobanks.\"}]","Autopsy Protocol v2.0 - Revision History and Protocol Metadata | PDF"]