Emory Research A-to-Z
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1 Emory Research A-to-Z AGENDA WHSCAB Auditorium 9:30-11:00 am November 17, 2011 IRB Update Important Changes to ClinicalTrials.gov OSP/OGCA Update Sponsored Projects Handbook Compass Reports to Manage Sponsored Programs Sarah Putney Director Institutional Review Board Office Wenona Favors Research Services Consultant Office for Clinical Research Kerry Peluso Associate VP OSP/OGCA Camilah Hick Director, Training& Communication OSP/OGCA James Goff Associate Director, Cost Analysis/Reporting Office of Grants & Contracts Accounting ANNOUNCEMENTS Next Meeting: January 19 th 9:30 am to 11:00 am Woodruff Health Sciences Administration Building (WHSCAB) Auditorium 1440 Clifton Road N.E. 1 st Floor Find information about ERAZ at topics and suggestions for future meetings to eraz@emory.edu. Your opinion and thoughts matter. Please complete the survey that will be sent out after this meeting. COI EHSO IACUC IDS IRB OCR ORAIT ORC OSP OTT
2 Meet eirb Jr! Emory Research A to Z November 17, 2011 Sarah Putney, JD Director, Emory IRB 1
3 Overview of Upgrades Servers Location of data and software Product version Some noticeable changes A bug and how to swat it 2
4 Servers Old server was retired Two new servers implemented Data on one Interface on the other Do users find it faster? Speed may vary depending on your hardware and location IRB staff notice faster page loading Future efforts are intended to increase speed 3
5 Product Version Upgrade eirb Sr. retired From to Many behind-the-scenes changes and improvements A few noticeable changes for users 4
6 Changes you may notice On study page, you can now set the number of items (entry lines) per screen view This allows you to scroll down to see much more in one screen Fewer clicks, fewer page loads Fewer delays! 5
7 How this looks: 6
8 Another change to notice Click on an entry in the study History Once it opens, click on forward/back arrows to browse through entries Saves time 7
9 How this looks: 8
10 Another change If your session is close to timing out A dialogue box appears click Renew Session No more logging back in! 9
11 A little bug Try to add a new entry for Funding, Drug, Recruitment, etc. Popup window to enter info may not open This bug is caused by a caching problem THE FIX: clear the cache in your browser Instructions will be posted on the IRB website soon Your browser type will require specific instructions 10
12 Questions? Thank you! 11
13 CLINICALTRIALS.GOV PRESENTED BY: THE OFFICE FOR CLINICAL RESEARCH (OCR)
14 OBJECTIVES: Provide a brief overview of ClinicalTrials.gov and some of the policies it supports. Describe the reporting requirements and the recent changes. Define Responsible Party and Applicable Clinical Trials (as per FDAAA). Find additional resource to carry out the registration and reporting requirements.
15 WHAT IS CLINICALTRIALS.GOV? A registry of federally and privately supported clinical trials conducted in the United States and around the world. Developed as a mandate by the FDA and launched in 2000 as a part of the Food and Drug Administration Modernization Act, Section 113. Beginning 2005 the International Committee of Medical Journal Editors (ICMJE) would not publish any articles about clinical trials if they had not been registered.
16 ICMJE REGISTRATION REQUIREMENTS All interventional trials (all types ) All types (i.e. drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes, etc.). All phases
17 FDAAA *801 US PUBLIC LAW September 2007, Food and Drug Administration Amendments Act, section 801 (FDAAA) was passed (US Public Law ). Requiring trial registration a legal requirement for a broader group. Requiring results reporting. Added penalties for non-compliance of this law. Penalties Include: Notices of non-compliance public record. Civil monetary penalties up to $10,000 per day. Potential for withholding of NIH grant funds.
18 FDAAA REGISTRATION REQUIREMENTS Applicable Clinical Trials (ACT): Interventional Trials - Drugs, biologics, devices. Studies in US FDA jurisdiction (i.e. IND/IDE or US site). Not phase I drug or small device feasibility studies.
19 FDAAA RESULTS REPORTING REQUIREMENTS Interventional trials Drugs, biologics, devices. Once approved by FDA. Not phase 1 drug or small device feasibility studies. Studies in US FDA jurisdiction (i.e. IND/IDE or US site). Generally within 12 months of primary completion date.
20 WHAT IS CHANGING? Changes have been made to the requirements of the protocol registration system according to US Public Law (FDAAA). Specifically the changes are being made to the requirements of the Responsible Party.
21 HOW DOES THIS CHANGE AFFECT YOU? Previously: Staff was able to update, edit and release protocol records in Clinicaltrials.gov. As of August 18, 2011: ClinicalTrials.gov now requires all PIs of investigator-initiated protocols registered on ClinicalTrials.gov to be registered users listed as the Responsible Party. Designated staff may continue to update and edit protocol records, however the Responsible Party must review the final record and release it into the system.
22 WHO IS THE RESPONSIBLE PARTY? Sponsors (as defined by 21 CFR 50.3) Sponsor-Investigators The individual who both initiates and conducts the study (PIs of PI-Initiated trials). Principal Investigators who are designated as the responsible party by a sponsor, grantee, contractor, or awardee - as long as the PI: is responsible for conducting the trial. has access and control over the data from the clinical trial. has the right to publish the results of the trial. has the ability to meet all the requirements for the submission of clinical trial information.
23 WHO DO THESE CHANGES NOT APPLY TO? PIs of Industry-Sponsored Clinical Trials who do not meet the previous criteria to be deemed Responsible Party by the sponsor. Site PIs of a larger study (where another PI at another institution is the Sponsor-PI).
24 HOW DO I OBTAIN A USER NAME AND PASSWORD? The Office for Clinical Research (OCR) is available to assist in the following: Verifying and Creating User Name and Password for ClinicalTrials.gov. Transferring Responsibility on a registered study to a registered PI. For assistance please OCR@Emory.edu.
25 WHAT IF I HAVE MORE QUESTIONS? Does my study qualify as a Clinical Trial that needs to be registered? How do I register or update my study in ClinicalTrials.gov? Does my study require to be updated? What information do I need to report? What is the rational behind this law? Does reporting results on ClinicalTrials.gov interfere with journal publication?
26 RESOURCES: Investigator Instructions PRS Information Page ( Brief Webinars Overview of ClinicalTrials.gov Key FDAAA Issues Protocol Registration System (PRS) Information and Data Review Process Protocol Registration System (PRS) Accounts and Registration Results: Participant Flow Module Results: Baseline Characteristics Module Results: Outcome Measures and Statistical Analyses Module Results: Adverse Events Module FAQs Additional written resources and links
27 Brief Website Tour of Resources
28 OSP and OGCA Update November 16, 2011 Projects Kiosk Awards and Contracts Systems Sub-Award System Compass Inquiry Screens Document Imaging Project Compass Cleanup Query Cleanup and Reorganization New Tools and Resources Sponsored Programs Handbook Reporting Guide. Post Award Cost Studies
29 OSP and OGCA Update November 16, 2011 Staffing Changes OSP OGCA DMG Roles and Responsibilities Information currently available Impact of other projects Communication Contacting AD s and Directors Newsletter Request for ERAZ topics Request for Ed Series topics Next Meeting:. Evelyn Balabis discusses OGCA Structure and Responsibilities
30 Grants Reporting James Goff
31 Grants Reporting Guide
32 Grant Reporting Guide
33 Grant Reporting Guide
34 nvision
35 nvision SPP2240
36 nvision SPP2242
37 FORS fors.emory.edu
38 FORS - SPP
39 FORS Project Trend
40 Custom Reports
41 Custom Reports PI Project Summary
42 Custom Reports PI Project Summary
43 Custom Reports PI Project Balances
44 Custom Report PI Project Balances
45 Custom Report Project Summary
46 Custom Report Project Summary
47 Custom Report Employees Paid From Project
48 Custom Report Employees Paid From Project
49 ORA Web Applications
50 ORA Web Applications
51 Tips Run by award number to see all projects across multiple departments and schools.
52 Have report ed to you instead of hitting refresh all afternoon. Tips
53 Emory University Cash Balance Report Accounting Period / Fiscal Year: 12 (Aug) / 2011 Dept SOM: Medicine: Cardiology Award Type Beg Date End Date Cash Balance A/R Unbilled A/R Def Revenue Budget Expenses Encumbrance Available Balance PILOT STUDY OF BNP LEVELS IN PATIENTS SCHED_PAY 12/19/2001 1/13/2010 (429.01) 0.00 (34,219.89) 34, W/CONGENITAL HEART 34, , (429.01) THE EMORY- MOREHOUSE PARTNERSHIP TO CR_LOC 248, (9,064.61) REDUCE CV DISPARITIE BIOLOGY, BIOMECHANICS AND CR_LOC (36,749.38) ATHEROSCLEROSIS DESCOVER REGISTRY OTHER (10,428.78) 10, ST JUDE MEDICAL CONSULTING AGREEMENT-LV OTHER 2, (2,559.80) LEAD PROGRAM - We hope to have a cash balance report available soon. Working to add names and salary amounts to project trend report. Updates
54 Updates Grant Inquiry Screens
55 Updates Grant Inquiry Screens
56 Updates Grant Inquiry Screens
57 Hope to have scheduling working soon. Updates
58 Name Title Phone James Goff Assoc Director, Cost Analysis/Reporting Jennifer Gore Assistant Manager, Data Services, Management and Operations Tammy Spain Sponsored Research Accountant Questions/Comments
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