US National Heart, Lung, and Blood Institute Data Repository

Slides:

Advertisements

Similar presentations

NBSTRN Update NCC/RC PI/PD Meeting November 19, 2010 Michael Watson.

Advertisements

Recently Issued OHRP Documents: Guidance on Subject Withdrawal and Draft Revised FWA Secretary’s Advisory Committee on Human Research Protections October.

1 Transportation Librarians Roundtable Transportation Research Thesaurus: WSDOT Use Cases February 14, 2008 Andy Everett Metadata Repository Administrator.

SPS Round Table The Use of Human Participants in Research Office of Research Integrity and Assurance (ORIA) April 17, 2007.

Digital Measures Managing and Reporting on Faculty Accomplishments Steve Hare Project Manager Office of Institutional Research, Assessment, and Effectiveness.

Internal Auditing in Research: The QA Process Research Education Series February 14, 2011 Sarah Dutkevitch, RN, OCN, Clinical Research Nurse Specialist.

Chad V. Seely Assistant General Counsel Tab 6.2: User Fee – Digital Certificate Fee Finance & Audit Committee Meeting ERCOT Public November 12, 2012.

Current Status Of The ERO Transition Activities To Comply With The 2005 EPAC ERCOT Board Meeting February 21, 2006 Sam Jones, COO.

The Services Charter of Eustat Cristina Prado / Alicia Barriocanal Helsinki, May 5 th, 2010.

9/17/ Access WHI: Proposing Analyses and Ancillary Studies Andrea Z. LaCroix, PhD Professor of Epidemiology and Co-PI WHI Clinical Coordinating Center.

NHLBI Gene Therapy Resource Program May 28, 2008 Sonia I. Skarlatos, PhD, FAHA Acting Director Division of Cardiovascular Diseases NHLBI Gene Therapy Coordinator.

RESCUE: ACRIN 4701 Protocol Development & Regulatory Compliance (PDRC) Josephine Schloesser, ACRIN Monitor Chris Steward, ACRIN QC Auditor.

Liz Bankert Director, Committee for the Protection of Human Subjects Dartmouth College Robert “Skip” Nelson, MD Associate Professor of Anesthesia and Pediatrics.

Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine Cancer Center Administration Database.

Human Subjects Research Cynthia Edmonds Director, Office of Research Support Committees.

ACHIEVING A LEARNING HEALTH SYSTEM THROUGH COLLABORATIVE ENGAGEMENT AND THE CREATION OF A STATEWIDE RESEARCH INFRASTRUCTURE AND CLINICAL DATA RESOURCES.

User Fee - ERCOT Digital Certificate Fee Chad V. Seely Assistant General Counsel ERCOT November 1, 2012 Technical Advisory Committee (TAC)

Seamus Ross Director, HATII & ERPANET Associate Director of DCC Services Funders: Service Definition & Delivery Digital Curation Centre a centre of expertise.

Western Oregon University INSTITUTIONAL REVIEW BOARD.

Riga, 2-3 February, 2011 ERASMUS PLACEMENTS Added Value or Added Work-Load? Jolanta Valiaugienė, Institutional Erasmus Coordinator.

Office of Sponsored Projects The Funding Life Cycle.

October 9 th, 2015 University of Pennsylvania TIES Cancer Research Network Y3 Face to Face Meeting U24 CA Session 5 Regulatory Update.

CLINICAL RESEARCH STUDIES Business & Finance (B &F) Prospective Patricia W. Davis Director of Research Office of Business & Finance

11 Proposed A-16 Portfolio Metrics Lifecycle Management Workgroup Geospatial Line of Business For Preliminary Discussion FGDC Coordination Group (09/21/10)

Office of Sponsored Projects The Funding Life Cycle.

IHE Product Registry Eric Poiseau Inria, Rennes. Purpose  A tool to search IHE Integration Statement published by Vendors.  Vendors register IIS  IIS.

Data Management – Regulatory Binder By: Johanna Park

Clinical Coordinating Center Social & Scientific Systems, Inc. Silver Spring, Maryland Project Coordinator: Susan Sepelak, MS, MSM.

IPDA Architecture Project International Planetary Data Alliance IPDA Architecture Project Report.

International Planetary Data Alliance Registry Project Update September 16, 2011.

Site Set-up and Conduct Caroline O’Leary and Carrie Bayliss.

Rare Diseases Clinical Research Network Data Management and Coordinating Center (RDCRN DMCC) Rosalie Holland LDN Investigator Meeting at WORLDSymposium.

Accessing the VI-SEEM infrastructure

Russian Academy of Sciences

Introduction to the Human Research Protections Office (HRPO)

Introduction to the Faculty Evaluation System

Making Data from NIAAA Funded Grants

Saint Joseph’s college of maine

NSDL: A New Tool for Teaching and Learning.

Introduction to the Faculty Evaluation System

Presented by: Samantha Walkow, Tasha Coughlin & Theresa Angus

Data Management – Regulatory Binder

Piloting IRBchoice at Vanderbilt

IRB Compliance Program PRS Administrator, Brian Brotzman

Roles and Responsibilities of the Clinical Research Team

NHLBI Perspective Yves Rosenberg, M.D, M.P.H.

Process Describing the Pathway from Initial IRB Submission of a Protocol to Approval of a Study Site Agreement (SSA) and Distribution of Site Agreement.

IBC Review Pathway Approximate Timeline Online status Online“Sub”State

Multisite Human Subjects Research

Proposal Phase Draft & Review Phase Approval Phase

New NIH Human Subjects & Clinical Trials Information

Linked Data – Another Strategy for Discovery and Access

Common Rule 2018 Exemption Changes

Retrospective Chart Review

Secondary Research with Identifiable Information and Biospecimens

Expedited Status Update January 14, 2019

Introduction to the Faculty Evaluation System

IRB Compliance Program PRS Administrator, Brian Brotzman

Proposal Processing Wake Forest University Health Sciences

Knowledge Base.

Signal Conditioning.

G. Michael Felker et al. JCHF 2014;2:

TOPMed Analysis Workshop Genetic Analysis Center Biostatistics Department University of Washington TOPMed Data Coordinating Center August 7-9, 2017 Introduction.

Overview Bitola, November 22-24, 2016.

The Revised Common Rule

Common Rule 2018 Exemption Changes

Common Rule 2018 Exemption Changes

Treasury of Russia INTERACTION BETWEEN INFORMATION SYSTEMS USED IN PUBLIC PROCUREMENT AND PUBLIC FINANCE MANAGEMENT – THE CASE OF RUSSIA. Alexandr.

Journal of Web Semantics 55 (2019)

Presentation transcript:

US National Heart, Lung, and Blood Institute Data Repository Sean Coady, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute

NHLBI Data Repository (aka BioLINCC) 1999 NHLBI IRB approves repository protocol. Website opens in 2000 BioLINCC established in 2009 to coordinate activities of Data Repository and Biorespository, Data access requests: Ethics/IRB committee approval or certification of exemption from review Describe project Agree to terms and conditions of data use agreement Administrative review only

Current portfolio: 40 Observational studies, 110 trials, 670,000 participants

Cumulative access requests for trial and observational study data

Annual average number of data access request per study per year available (2012 – present)

Time to “Incident” publication by type of study (through January 2017) 1 Year CT: 5.1% OS: 2.8% 776 publications 53 Trials 1+ publications 18 Observational studies 1+ publications 3 Year CT: 21.1% OS: 19.9% 5 Year CT: 37.6% OS: 42.0% Notes. Time 2 pub by PI. 28% within 3 years and 35% within 5. Right about half publish at all. Log-rank p=0.714

Cost and effort Total annual cost $1M (US) per year Effort (FTEs) Approximately half associated with biospecimens and half for data activities Effort (FTEs) Total FTE Web platform, maintenance, document remediation/posting 2.30 Analytic Support (review, data prep, queries with submitters) 1.40 Biospecimen support (search, pull lists, inventory management) 1.15 Communication (access requests, user support, web documents prep) 0.75 Senior Management 0.80

Future directions Indexing datasets, moving toward FAIR compliance Cloud platform to support digital images, signal data, etc.

https://biolincc.nhlbi.nih.gov/home/