Clinical Research Workflow

Slides:



Advertisements
Similar presentations
CMRSC Division of Hematology/Oncology
Advertisements

CROMS NIDCR Clinical Monitoring
Tips to a Successful Monitoring Visit
The HRPP FYI Process and the UPIRSO/SAE Review Sheet An IRB Infoshort February 2014.
USC Clinical Trials Office (CTO) Answers to CTOs who, what, when, and how questions Soheil Jadali Director, Clinical Trial Office.
Summary Care Record (SCR) A change to the GP contract, planned to come into effect from April 2014 is that:- ‘GP practices will be required to provide.
Research Study Initiation Process GRU CLINICAL AND TRANSLATIONAL RESEARCH LABORATORY RESEARCH ANIMAL RESEARCH HUMAN RESEARCH GRU Clinical.
USF Research Integrity & Compliance eIRB Comprehensive Training 10/07/2014.
Submission to Approval What happens to my protocol once I submit it to the HIC office.
CRC Protocol Documents Protocol Submissions Amendments Publications Study Closure.
TATS – TA Report Submission Department of Health and Human Services Health Resources and Services Administration HIV/AIDS Bureau.
UCSF Medical Center CTG – April 3, 2014 Project: MyChart – Patient Attachment File BCD Project Manager: NA UCSF Medical Center.
Chicken Soup for the Busy Coordinator Nov 2010 PROTOCOL FEASIBILITY.
Special Education Student Information System Project New York City Department of Education | Special Education Student Information System Project 1 SESIS.
Hiring Manager/Supervisor Training Offer Letters.
Coordinator University Clinical Research Pharmacy Investigational Drug Service (IDS) Marjorie Shaw Phillips, MS, RPh, FASHP Clinical Research Pharmacist.
MODULE I Close-Out Visit/Monitoring Reports Jane Fendl April 24, Versions: Final 24-Apr-2010.
Nursing Research Project Idea? CALL Center for Nursing Research & Practice Is it research or quality improvement? Once your submission is.
Monitoring IRB Monitoring of Clinical Trials. Types of Monitoring Internally Internally Externally Externally.
Essential Documents and Regulatory Files Lack of planning can constitute an emergency Rachel Sheppard Regulatory Director, OCRSS.
DOI Complaint Response Timeline Claims Services 2015 This timeline is applicable to DOI Inquiries/Complaints for all states where we do business. The dates.
LETTER OF INTENT FOR INDUSTRY SPONSORED RESEARCH Signe Denmark, SCTR Research Opportunities & Collaborations Ryan Mulligan, SCTR Grants & Contracts Navigator.
Study Closure Process Entropy is not a method Rachel Sheppard Regulatory Director, OCRSS.
Quality Education for a Healthier Scotland Overview of Appraisal Processes on SOAR for Appraisees (Primary and Secondary Care)
JCRI Business Operations – Post-Award. Processes relating to the collection of sponsored clinical trial funding.
Getting a study done at Jefferson:. Startup Activities: Image courtesy of CITI Program Clinical Research Coordinator course.
Ver. 02/13/  Registration  New Studies  Continuing Reviews  Amendments  Reportable Events  Tips & Tricks  Questions 2.
Project Manager (CTM) Training – What’s New ePIP Phase II.
Welcome New IRB Member! This brief presentation covers: Your Role in the IRB: What to Know The IRB Review Process Resources Human Research Protections.
CONDUCTING COMPLIANCE ASSESSMENTS Allen Ditch Director Corporate Quality Bristol Myers Squibb Medical Research Summit March 6, 2003.
May 5, 2016 Working With CTO Contracting: How Do I Get My Clinical Trial Contract Negotiated & Why Isn’t It Signed Yet? Jaci Brown, Manager, CTO-Contracting.
© 2016 University at Buffalo Click Training Safety Module University at Buffalo Office of the Vice President for Research and Economic Development Electronic.
Responsibilities of Sponsor, Investigator and Monitor
California State University, Los Angeles Department of Public Health PH 4960 Internship Course Policies and Site Information Advisor: Behjat A. Sharif,
ClinCard System: Medical University of South Carolina
Research Approval Workflow EPIC Optimization
Decision Tree for eIRB Submission Revised: 01/25/2016
EPIC Tools for Clinical Research
Polices, procedures & protocols
Responsibilities of Sponsor, Investigator and Monitor
Study Feasibility and Start-up
MAINTAINING THE INVESTIGATOR’S SITE FILE
External Project from TIN
Decision Tree for eIRB Submission Revised: 01/12/2016
California State University, Los Angeles Department of Public Health
Invoices to Sponsor in the CRC role
Welcome New IRB Members!
360o Feedback Report Post-Training After-Session Actions
Decision Tree for eIRB Submission Revised: 01/25/2016
Partnering with the Defense Acquisition University Equivalent Provider Application (EPA) Process Phase I - Details END NO YES Provider contacts an approved.
Top Ten eIRB Application Mistakes
SUNY Pre Award and Compliance Systems Institutional Review Board (IRB)
Getting a Study Done at Jefferson:
Click Training Agreements Module
HREC Operating Procedures for the Review of Low and Moderate to High Risk Projects
Basic iRIS Features and Submissions
10. Visit illinoistollway.com
UW-Madison Central IRB Gateway
MAINTAINING THE INVESTIGATOR’S STUDY FILE
RECRUITING Staff and Student
Psychology Learner Quick Start Guide:
Proposal Processing Wake Forest University Health Sciences
EPIC Tools for Clinical Research
Psychology Learner Quick Start Guide: Practicum/Internship Application
USF Research Integrity & Compliance
Click Training Safety Module
Hannah Helmstetter & Meredith Capasse July 12, 2019
Patty Orndoff RN, MEd IRB Education Coordinator
New Research Access Processes IU Health Research Access Team Effective August 15, /18/2019.
Compliance Manual Update Staff Requirements Check
Presentation transcript:

Clinical Research Workflow UMH listed as study site in ePRost Research Analyst (RA) notified of research protocol via eProst automated email or direct email from ORA No RA notifies study coordinator to add UMH as study/performance site Yes RA ensures UMH Clinical Research Services form uploaded to eProst and completed correctly, including required resources RA reviews protocol details and requests additional information from study team as needed Additional information may include: CMS/FDA letter Recruitment brochure Sponsor details RA works with study team to address requirements and prepare for Research Review Committee Study team to prepare presentation template, to include resources, budget and contract requirements Observational studies and chart review may not warrant approval by Research Review Committee When budget and contract nearing finality, RA coordinates study team presentation to Research Review committee for approval RA submits approval in eProst when approved by Research Review Committee and forwards approval letter to study team Approval may be delayed pending final contract, budget or IRB issues RA works with study team to coordinate Site Initiation Visit (SIV) RA advises study team to initiate in-services for applicable departments Staff training log to be emailed to Research Analyst RA confirms IRB Approval in eProst RA coordinates appropriate access to UMH departments and Medical Records Version Date: 04/11/2017