ROAR. Welcome! Research Operations and Administrative Rounds. ROAR Clinical Research January 14, 2014 Lecture Room D

Transcription

1 ROAR Welcome! Research Operations and Administrative Rounds ROAR Clinical Research January 14, 2014 Lecture Room D

2 ROAR Research Operations and Administrative Rounds Agenda Paul Primrose Welcome & ORA Announcements Jen Schaefer- Research Concierge Terry Novchich CTO Announcements Vincent Falvo- Clinical Trial Finance Laura Young / Jim Taylor (Penn State Office of Research Protections) CATS Kathy Hay HSPO Announcements

3 ROAR Research Operations and Administrative Rounds Upcoming ROAR Meetings March 11, 2014 Grants 9am Lecture Room B April 8, 2014 Clinical 9am Lecture Room D

4 Upcoming Events

5 Upcoming Events

6 Upcoming Events

7 Upcoming Events

8 Interdisciplinary Research Support Core (IRSC) Sarah Bronson, Ph.D. Director Jennifer Schaefer, M.S. Research Concierge

9 What is the IRSC? Established by the Office of the Vice Dean for Research & Graduate Studies in collaboration with the Clinical and Translational Sciences Institute (CTSI), the IRSC has three primary aims: 1. Help investigators navigate the infrastructure at the College of Medicine (COM), 2. Support by working with internal and external partners to build collaborative research teams, and 3. Deliver that are to the institution.

10 Who directs the IRSC? Associate Professor of Cellular and Molecular Physiology 20+ years research experience Co-Director of the Junior Faculty Development Program (JFDP) Actively involved in mentoring and training Former private sector consultant with 16 years experience in economic development and community planning Specialist in public funding and project management

11 Why is the IRSC needed? To remain competitive for federal funding, investigators will increasingly have to engage in that crosses academic disciplines, campuses, and institutions. The private sector is also becoming an increasingly valuable resource for team-based research. Research teams that engage multiple academic disciplines can yield tremendous innovation, but the process of team engagement is extremely time-intensive. The IRSC provides dedicated project management and staff support to cultivate team-based research.

12 What does the IRSC do? The IRSC can provide the following support services: investigators to potential collaborators with funding agencies to be proactive in the development of research strategies staff application development with department outreach activities to educate faculty and staff on available resources intellectual property, as applicable a web-based research concierge portal for virtual assistance

13 Preliminary Goals Increase submission and funding rates for: Institutional and individual training awards Interdisciplinary research awards Multi-investigator, program, core, and consortium awards Strengthen application development in coordination with: Individual Departments Research Development (RD) Office of Research Affairs (ORA)

14 Preliminary Goals Develop a portfolio of industry experts that can inform research and expand market reach in the following areas: Commercialization Clinical trials International clinical and research collaborations

15 Next Steps for the IRSC Form an internal IRSC Advisory Board Conduct best practices research Strengthen the Research Concierge web presence Grow our knowledge of institutional strengths Develop a strategic plan with short- and long-term goals and objectives Continue outreach efforts with faculty and staff

16 Things to Consider We want to understand your needs and ideas so we can provide value-added service. The earlier we are engaged, the more effective our support. It is harder to build effective teams and competitive funding applications in response to an urgent FOA. Investments made today to create effective teams will yield long-term funding success because these investments.

17 Contact Information Jennifer Schaefer, Research Concierge Room: #C1742G at the CTSI Telephone: ext Web Address:

18 CTO Updates Terry Novchich COM Clinical Trials Office January 14, 2014

19 Account Access Requirements New process in place Account request form completed Revised form Two new documents required Pages from the IRB-approved consent (Sections 7.a. and 7.b.) noting who can view information Memo from study team member stating all enrolled subject has signed a consent Submit all documents together Allow 2 weeks for approval

20 Mandatory Reporting of NCT Number CMS (Medicare) will require as of January 6, 2013 the 8-digit Clinical Trial Number on claims NCT number from ClinicalTrials.gov website Coordinator must communicate this information when subject seen for clinic visit Need IRB#, budget/fund#, NCT#

21 CTO Updates Protocol feasibility and budget meeting reminders Please provide manuals (lab, radiology, operations, pharmacy, etc.) at time of electronic submission Come prepared to discuss conduct of study and any challenges you foresee Respond to homework assignments in a timely manner

22 Update Internal Research Contact List Recent moves and new personnel prompt a review and update of research contact list found on: Infonet Departments Clinical Trials Office Information and Resources Internal Research Contacts

23 Update Internal Research Contact List Review and send changes/additions/deletions within the next week to: Robinn Moyer in Office of Research Affairs at Will also be added to the ROAR and IRB distribution lists for announcements

24 ACRP Chapter Meeting Developing Central Northeast PA chapter with Geisinger Hospital Meeting will be in mid-march at HMC FDA auditor to present Proposed ~5:30 PM start time Meal to be provided Small fee for CE hours

25 Clinical Trial Finance Centralization WHY IT IS HAPPENING, WHAT IS HAPPENING, HOW WILL IT HAPPEN, AND WHEN? By Vincent Falvo, Associate Controller January 14, 2013

26 Clinical Trial Finance Centralization WHY? Audit and consulting reports have demonstrated inconsistencies and inefficiencies on: 1. Charging effort and other expenses 2. Invoicing, managing receivables 3. Managing compliance risks 4. Varying degrees of expertise and reporting 5. Lack of attention to budget vs. actuals 6. Department staff are doing similar tasks

27 Clinical Trial Finance Centralization Current Status: Financial Activity Scattered in Departments and Inefficient. Pediatrics Medicine Cancer Derm Neurology HVI

28 Clinical Trial Finance Centralization What? Clinical trials and other related studies that lend themselves to a consistent process. * For example, for-profit, government, and not-for-profit trials with milestones. * Possibly data collection studies. * Not cooperative group trials, they closely resemble standard of care.

29 Clinical Trial Finance Centralization Some of the duties to be centralized Budget negotiations Invoicing Accounts receivables Collections Posting of effort (salaries) Posting of other expenses Compliance Comparing budgets to actuals Centralized reports to departments Other duties as deemed important to our customers

30 Clinical Trial Finance Centralization HOW? Hiring two additional FTEs: 1 Pre-award (TBD) 1 Post-award (TBD) Combining with current positions: 1 Pre-award (Michelle Stanton) 1 Post-award (Jonathan Croft) Shifting an existing Controller position: 1 Post/Pre-award (Kellen Takoch)

31 Clinical Trial Finance Centralization These members will continue to work closely with the Departments financial analysts, faculty, and clinical trial coordinators. They will attend clinical trial budget meetings and any other relevant meetings.

32 Clinical Trial Finance Centralization WHEN? IN FEBRUARY 2014, THE GROUP WILL BE ASSEMBLED. Individuals will be assigned departments. They will begin, by meeting all the financial analysts and meet with faculty and clinical coordinators in phasing in new clinical trials. They will gradually phase in open trials. By the new fiscal year we will reassess our customer needs, and adjust our staffing and processes accordingly.

33 Clinical Trial Finance Centralization Cancer Institute HVI Derm Clinical Trial Finance Medicine Pediatrics

34 CATS-IRB Update Jim Taylor & Laura Young Office for Research Protections

35 CATS IRB Update As of 12/10/13 CATS IRB is live for: HHD Nursing COM HMC Purpose of Phased roll-out Identify and support user issues Solve critical problems Stabilize system for full go-live

36 CATS IRB Update 12/10/13-1/10/13 submission counts in CATS IRB are: Submissions New Studies - 47 Continuing Review - 12 Modification 46 Modification and Continuing Review - 30 Reportable New Information - 61

37 CATS IRB Update Resolution being sought for the following issues: Browser incompatibility Quick print options for follow-on submissions Notification of assigned meeting date

38 CATS IRB Issues Resolutions put in place for the following issues: Inconsistent Training Data Accessing CATS IRB from link provided in notifications

39 CATS IRB Update Converted Studies Assistance Go to: CATS IRB IRB Library Templates Tab HRP-503 Next Steps for Converted Studies For IRB Researchers Contact HSPO, ORP or for help

40 CATS IRB Schedule Jan-Mar 2014 Provide helpdesk support for CATS IRB Tracking and resolution of identified critical issues March 2014 CATS IRB go-live for remainder of University Spring 2014 Begin CATS IBC/UIC planning

41 IRB Updates Kathleen Hay, PhD, CIP Human Subjects Protection Office X5687

42 HSPO/IRB Update Address change as of Feb. 1, 2014 HSPO 90 Hope Drive Mail Code A115 P.O. Box 855 Hershey, PA All external mail sent to the ASB should include PO Box 855, Hershey, PA as the last two lines of the address.

43 Conversion Process Conversion of PRAMS studies to CATS Use the following guidance documents HRP-503 Next Steps for Converted Studies For IRB Researchers HRP-503 How to Upload a Protocol for a Converted Study HY Available: CATS IRB Library: Templates Help - Provides steps for using CATS IRB Study Submission Guide

44 Materials to Upload Converted Studies Basic Information page Protocol (Table in How to Upload a Protocol for a Converted Study ) Drugs or Study Devices pages Current Investigator Brochure Device Information Consent Forms and Recruitment page For studies open to accrual Word version of current consent form(s) Current recruitment materials For studies closed to accrual If applicable, Word version of addendum(s) to consent

45 Materials to Upload Converted Studies Supporting Documents page Grant if applicable For studies open to accrual or studies closed to accrual but subjects are receiving study intervention or non SOC procedures Data collection materials surveys, questionnaires, interview questions, etc.

46 Consent Forms for Converted Studies If you do not need any other revisions: Use Word version of the latest approved version Leave the version date as is Remove the stamp box in the header Remove the list of other investigators from page 1 If you have revisions for the consent form: Use Word version of the latest approved version Use tracked changed function in Word Update the version date Revise the document using tracked changes Make any revisions that you need Make all changes needed to match new consent form template

47 Department Chair Notifications For new studies submitted in CATS IRB Department Chairs receive notification when a PI in their department submits a new study No longer have to sign assurance page Dept chair does NOT need to take any action in CATS IRB for the study submission to continue If they don t want the submission to continue they need to contact the HSPO

48 Adding Investigators in CATS IRB When adding an investigator to a study who is not in the list of researchers in CATS IRB On Study Team Members page Select Add On Add Study Team Member window - Select Click here to add a new person to the list If individual is a PS or HMC faculty, staff, student, enter his/her PS Access Account ID (e.g. abc123) and department from drop down list Can obtain PS Account Access ID from Penn State Directory HMC Infonet under Directories Only if individual is not a PS or HMC faculty, staff or student should you check This individual does not have a Penn State Access Account.

49 CATS IRB Help and Training For help with using CATS-IRB Call HSPO ( ) system link: Systems questions may be directed to link on CATS home page CATS IRB Training: See IRB website, Educa. Resources for dates Jan. 15, Jan. 23, Feb 12, March 20