Managing Patient Contact Studies at a Central Registry

Slides:

Advertisements

Similar presentations

Common Errors to avoid in IRB- 03 (VA) Applications.

Advertisements

October 2001 Tidemark User's Conference1 Session: Records Management Principles Presenter : Robert Monzon, City of Pasadena Date: Wednesday October 3,

National Cancer Institute (NCI) Central Institutional Review Board (CIRB) Research Studies UCSF HRPP Submission Process Overview Tuesday, December.

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

November 10, Office of Research Administration: Clinical Research Contracting Presented to: Research Administration Professionals Group Patricia.

N A managed approach to planning and controlling the implementation of complex application software. n A flexible tool kit, designed to support the Project.

By Garland Land NAPHSIS Executive Director. Performance Measures Committee Dorothy Harshbarger, Alabama Dorothy Harshbarger, Alabama Barry Nangle, Utah.

National Death Index: Monitoring the Slippery Slope Lou Saadi, Ph.D. Kansas NAPHSIS Annual Meeting, 2007 Salt Lake City, Utah.

Tuesday 13 th October MIREC Documents Procedures MIREC-1 - Terms of Reference & Procedure for MIREC Review of Research Projects Involving Human.

British Association of Dermatologists’ Biologics Intervention Register Approval Process July 2007.

Research and Development Protocol Submission and Continuing Review Processes Kimberly Summers, PharmD Assistant Chief for Clinical Research South Texas.

How PIs and the NIH Communicate: eRA Commons and Progress Reports Susan McCarthy DCB New Grantee Workshop March 15, 2013.

Ensuring Human Subject Protection A Guide for Those who Obtain Research Informed Consent Documents 10/15/20151.

BNR – Stroke: data entry and data management CAREC/PAHO Curacoa,15-16 November 2010 Gina Pitts, BNR-CVD Registrar Chronic Disease Research Centre, Jemmotts.

Complaints Resolution Framework March What is a Complaints Resolution Framework? The International Standard on complaint handling ISO 1002 directs.

VHA Handbook What’s new. General Requirements for Informed Consent A Legally Authorized Representative may not always qualify as a ‘personal representative’

ISO Environmental Management Systems 1 ISO LEGAL AND OTHER REQUIREMENTS.

Sarah Faghihi Research Compliance Decision Support Analyst Office of Research Administration Faith Pottschmidt, JD Director, Clinical Trials Contracting,

P2Rx Web Group Fall 2003 Update. Coding Management Items covered today Topic hubs being shared Modularized Topic Hub Code CVS server (managing code) –Topic.

Integrating a Federated Healthcare Data Query Platform With Electronic IRB Information Systems Shan He IPHIE 2010.

UPDATING RIGHT OF WAY MANUALS FLORIDA’S PROCEDURES.

Social Roles and Relationships.

Post-Approval Monitoring (PAM) Program November 17, 2015.

MODULE A - ADMINISTRATIVE. ASME C&S Training Module A1Slide 2 MODULE A - ADMINISTRATIVE SUBMODULES A1. Tools and Resources A2. Codes and Standards Products.

Institutional Review Board Procedures and Implications After the applied dissertation committee has approved the proposal and the IRB package, the student.

UNM Virtual Human Biospecimen Repository -- Pitfalls and the Possibilities UNM Biocomputing Conference April 22, 2005 Philip J. Kroth, M.D., M.S.

Jennifer Sharp, JD IRB Director

Data Coordinating Center University of Washington Department of Biostatistics Elizabeth Brown, ScD Siiri Bennett, MD.

NAU New Project Submission Guidance for creating a new project.

CITI TRAINING FOR THOSE INVOLVED IN CLINICAL RESEARCH.

Institutional Animal Care and Use Committee

A FRUIT AND VEGETABLE PRESCRIPTION PROGRAM

Lisa Hoebelheinrich, JD, CHRC Associate Vice Chancellor, Compliance

Normalized bubble chart for Data in the Instructor’s View

Guidance for VCA Deceased Donor Authorization (Resolution 7)

REVISIONS DATE SLIDE CHANGE 11/22/10

School Stability and Transportation Coordination for Children in Out of Home Placement Philadelphia Department of Human Services and School District of.

Introduction to the Human Research Protections Office (HRPO)

4.4 Monitor and Control Project Work

Patient Registries and Health Outcomes in Diabetes: A Retrospective Study Nipa Shah, MD1; Fern Webb, PhD1; Liane Hannah, BSH1; Carmen Smotherman, MS2;

Beverley Alberola, CIP Associate Director, Research Protections

Eddie Fung (TURN Community Services; Salt Lake City, UT)

Order from Chaos: Improving Quality of Care in a Resident/Faculty Practice Through Integrated Team Meetings Jennifer Leiser, MD, Sonja Van Hala, MD, MPH,

Progress Report Preparation and Submission

Training Requirements for PI and Research Staff

West Jordan Garage Door Repair

Leaning Out the Nursing Policy and Procedure Process

Regulatory Binder: Maintaining Essential Study Documentation

Claire McKinley, PMP, CCRP

STEP 8 - CLOSING PHASE: TRANSITION SUPPORT

Cayuse Log-In Office of Research Compliance, v1-2016

TEXAS SUPPLEMENT WAREHOUSE

Click Training Agreements Module

Wharton Audit & Compliance\ January 19, 2018

Institutional Review Board

Northwest Tribal Epidemiology Center

Rationale, Key Processes and Roles

Just In Time Concepts & Review

Campus Research Administrators Meeting

Arizona House Calls CareLink

SciQuest Update Purchasing and Distribution Services FAR

Proposal Processing Wake Forest University Health Sciences

Back to Basics Initiative:

Human Gene Therapy Institutional Review Procedures

Internal Audit Who? What? When? How? Why? In brief . . .

Megan Eguchi, MPh Sana karam, md, phd

Managing Internal/External Sales in EFS

CTSA27 So you want COMIRB to be your sIRB: What you need to know.

Click Training Safety Module

Presentation transcript:

Managing Patient Contact Studies at a Central Registry C Janna Harrell, M.S. Antoinette Stroup, PhD Susan VanRoosendaal Utah Cancer Registry University of Utah Salt Lake City, Utah

Outline UCR Study Procedures Preliminary Work Data Tracking Implementation Data Storage Administrative Database Study Database

UCR Study Procedures Researcher needs IRB & ARC approval Policy: UCR obtains patient consent Cost Communication

UCR ARC IRB/RGE Researcher/Staff

Tracked Information PATIENT LEVEL Demographic Cancer Contact Status STUDY LEVEL Staff Study Review Process

Data Storage Admin Database Staff Review Study Study Database Patient Contact Status

Administrative Database

Main Tables: Supplemental Tables: Staff: personnel information Study: study information Review: review committee details Training: staff training type and dates Supplemental Tables: Staff Study Linking List tables: Training, Review, Role

IRB ARC RGE IHC… CITI VA NIH PI, CoPI, RA, …

Execute Reports View and input data

Forms for Viewing and Entering Data

Reports

Study Database

Main- all patient information Main Tables: Main- all patient information Contacts- all contact information Supplemental Tables: List tables: contact types, final codes, & follow-up contact relationships

Study Database Relationships

Study List Table: Contact Types

Study List Table: Final Code

Forms for Viewing and Entering Data

Study Reports

Table for Researcher

Report: Call List

Thank you! Questions?