September 18, 2012 al Research Administrators Workgroup

1. September 18, 2012al Research Administrators Workgroup

2. Agenda Introductions Announcements / Updates Partners Advancing Careers through Education (“ACE”) Initiative NIH Updates New Deficit to Sundry Write-Off Policy Grant Administrator Refresher Training Updates from Research Management PCRO PD Implementation

3. McLean F&A Rates DHHS Agreement date: 09/13/2012 McLean DHHS Rate Agreement, IDC & Fringe: PDF Fringe Benefit Rates:until amended: 32.0% Indirect Cost Rate (i.e., 'Facilities and Administrative' or 'overhead'):10/01/2010 - 09/30/2014: 58.0%10/01/2014: until amended: 58.0%

4. Account Inactivation in PeopleSoft Effective October 1, 2012 : Account number 959800 (Miscellaneous Outside Service Expense) will be replacedby 952200 (Other Outside Services) Account 959800 will be inactivated in FY13 and should no longer be used. A total of 18 account numbers are being inactivated in FY13 in an effort to eliminate duplicate and underutilized accounts from the general ledger. Only one of the 18 accounts, 959800, impacts research. 4

5. Account Inactivation in PeopleSoft What does this mean? InfoEd budgets will automatically be updated to replace 959800 with 952200. 959800 is used in InfoEd to budget Other Expenses. Department Administrators do not need to initiate any changes to InfoEd budgets. Materials Management is automatically converting all open purchase orders, P card and travel expenses to the new account number. Department administrators do not need to initiate any changes to existing purchase orders. Any new purchase requisitions, P card orders and travel expenses initiated going forward, will need to use the new account number 952200. Fund Balances will not be affected by the inactivation of the account. Fund balances will still calculate correctly even though balances remain in 959800. Activity previously posted to 959800 in the general ledger will stay in 959800. 5

6. Account Inactivation in PeopleSoft Journal entries submitted for the October 2012 close must use 952200. Any journal submitted to Research Finance in October 2012 that contains account number 959800 will be changed to 952200 by Research Finance prior to posting. Cost transfers to move vouchers that were previously posted to 959800 must use 952200. Cost transfers should be submitted with the original voucher number. Research Finance will verify the original voucher. The charge will need to be transferred by crediting 952200 instead of 959800. The cost transfer may result in a credit balance in 952200 on the fund from which the transaction is being moved. The original charge will stay as a debit to 959800. Both 959800 and 952200 are reported in the Other Expenses budget category. In total, the Other Expense budget category will be correct. 6

7. Account Inactivation in PeopleSoft 7

8. PHS Online College Preparation Program: Opening the Doors to College by Expanding Access and Supporting Success MJ Ryan, PHS Workforce Development Manager Kathryn Decelles, PHS Career Coach September 18, 2012

9. Overview • Technology as enabler of education and career advancement • Benefits for Partners employees • PHS Online College Prep Program (OCPP) • Critical Success Factors • Participant feedback and outcomes • Learn more…..

10. Technology as enabler of college readiness and success Online Learning benefits working adults • Scheduling flexibility • Commuting reduced or eliminated • Child care issues minimized • Release time not required • Job-related technology skills improved • Confidence and competence increased

11. OCPP: Preparing PHS employees for online learning • Simulated online learning environment • Multi-media • Interactive • Current course modules: (2-3 weeks each) • Orientation and Online Readiness Course • Study Skills • Time Management • “Moving on to College”(prep for QCC Med Term course)

12. OCPP: Critical Success Factors • 4 C’s • Coaching • Cohorts • Community manager • College collaborations • “Social learning” platform • Social networking combined with online learning technologies • Technology familiar to many employees (“Facebook” users) • Interactive, fun (not “online textbook”) • Peer learning and support

13. OCPP : Home Page- V 2.0 – Original platform

14. OCPP : Home Page- V 3.0- NEW VLC Platform

15. Results to date • Online Advance Modality Medical Imaging Program: Partnership with Bunker Hill CC (BHCC) • Curriculum/programs designed in collaboration with Bunker Hill Community College (BHCC) • MRI, CT, Mammography certification prep for incumbent RTs • Over 30 Partners employees graduated 2008-2011; many now certified • Programs start annually in Sept.; enrollment in March; open to PHS and non-PHS students • Online College Preparation Program (OCPP) • Approximately 500 employee participants (5/10-6/12) • Online College Courses: Partnership with Quinsigamond CC (QCC) • Medical Terminology • 133 enrolled 5/10-7/12; 17 currently enrolled • 115/133 completed (87% completion rate) • 97% completers earned grade B or better • Developmental Math • 3 levels pre-college math offered • 23 enrolled 5/11-5/12; enrollment currently open • 87% completion rate*; 75% completers earned grade B or better

16. Employee Feedback OCPP: “I enjoyed this online course. I didn't think I was cut out for online coursework, but it worked out pretty well for me and I look forward to doing more coursework online now that I have the experience.” “I’m glad I took this course it got me in motion and motivated to get going with my (college) application process.” QCC Online Medical Terminology Course: “I'm very grateful about this opportunity of getting courses online. Being a single mom with 3 kids, this is really great.” “My ability to stick to deadlines has improved…I've been more productive…Thanks to this class, I am confident I can excel in other courses, in or outside of a classroom.” QCC Online Developmental Math: “It has been an exciting journey and I thank God for completing the math course successful.  I wouldn't have gotten there without the able support of my professor and you.” “…if I were asked to evaluate Prof. Potvin, I would give her EXCELLENT.  She has been a wonderful and awesome tutor with her encouragement, kind words and support which gave me so much confidence to successfully complete this course and I am indebted to you both.  Thank you very much.”

17. PHS “ACE”: Advancing Careers through Education • Career Coaching • Academic advising • Career exploration • Financial aide assistance • Support and cheerleading for employee students • Onsite College Placement Tests • College Placement Test Prep Info and Guidance

18. Participant Success: Houda Nahed "I started my educational journey in 2009. I've just completed my 3 courses online and I'm enrolled at BHCC in the Medical Assistants Program. Together with the help of my coach, I was able to overcome “life" getting in the way of my goals." "I plan to complete additional courses online because of my positive experience." Houda Nahed Sept, 2010 Enrolled in BHCC Medical Assistant Program Long Term Goal: Medical Imaging Tech or Nurse Enrolled in Allied Health Initiative 2009 August, 2010 Completed QCC Online Medical Terminology (B+) July, 2009 Completed Straighterline web-based pre-college program April, 2010 Completed Online Readiness Course Took onsite CPT exam early 2010

19. Questions? Next steps…

20. NIH Updates

21. NIH Human Subjects Research Review Guidance NOT-OD-12-129: Any change in research procedures in an active award that would result in an increased risk to human subjects requires prior NIH approval before implementation. This includes: • Change in protocol that results in change in human subject designation or clinical trial designation • New inclusion of vulnerable population(s) • Protocol change that increases overall risk • New information after study underway that indicates higher level of risk than previous recognized Source: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-129.html

22. NIH Human Subjects Research Review Guidance NOT-OD-12-130: Clarifies requirements for awards which were submitted with the intent to conduct human subjects research but without definitive plans in grant application: Delayed Onset Awards. • Must submit detailed section to NIH Institute & Center for approval at least 30 days prior to beginning work • Signed by Authorized Organization Representative Source: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-130.html

23. NIH Special Review of $1M Investigators Policy NOT-OD-12-140: • Special Council Review of research project grant applications for investigators w/$1.0 million per year of direct costs from active NIH awards • Previous threshold $1.5 million/year total costs • Not a cap on NIH funding • Beginning September 2012 • Applies to new grant submissions Source: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-140.html

24. JIT Notice NOT-OD-12-101: • The NIH recently announced that as of April 20, applications receiving an impact score of 40 or less will receive a standard notice and request to submit JIT information through the NIH eCommons. • PI’s are strongly encouraged to contact their Program Officer to determine if the proposal’s score is in the fundable range. However, submitting the JIT material is at the PI’s discretion. • If there are Human Subjects or Animals Studies proposed in the application, IRB or IACUC approval is required at JIT. If there is an existing protocol the PI must amend the protocol to have it approved for use with the application under consideration. Source: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-101.html

25. New Deficit to Sundry Write-Off Policy

26. Revision to Current Sundry Write-Off Policy New Policy: Effective 10/01/12 Departments will be granted a six month period after the project end date to write-off deficits for direct costsonly. Deficit write-offs processed more than six months after the project end date must be submitted for total costs. The six month write-off period is defined by comparing the calendar month in which the project expired to the calendar month in which the journal is submitted. For example, the deficit on a fund that expired on any day in June 2012 can be written-off as a direct cost write-off through December 2012. Deficit clearing journals submitted after December 2012 must be submitted for total cost. * Policy is consistent between BWH and MGH and endorsed by the SVP’s and CFO’s 26

27. Grant Administrator Refresher Training

28. GA Refresher Training What: Two Day Training for Administrators When: Thursday November 8 and Thursday, November 15 Where: Pierce Hall Who: All administrators

29. GA Refresher Training Our current training program is as follows: Introduction to Research Management Federal Grants Policy 101 Research Management Policy Overview Introduction to Pre-Award Concepts and Services Introduction to Post Award Concepts and Services Developing and Monitoring Subcontracts Introduction to Research Finance Concepts and Services

30. RM “Quarterly” Training Schedule 2012 All classes are held at 101 Huntington Avenue, Boston, 3rd floor large conference room. Please search in PeopleSoft to request enrollment.

31. GA Assessments In the effort to increase GAs skills and qualifications, a certified Partners training program will be available for administrators at McLean. All categories with the exception of the Grant Coordinators will be required to take an assessment in specific areas (Finance, Pre-Award, Post-Award, Compliance, etc.) and meet a minimum score. Research Administration will review with administrator areas of weaknesses.

32. Continuation - GA Assessments Research Administration will meet with GA’s to review the assessment results Assessment will include ~ 100 questions (multiple choice, mix and match) Assessment date to be confirmed

33. Updates from Research Management

34. FY12 Pd 2 Effort Certification • Any Questions? Ask the Effort Reporting Team! phseffort@partners.org • On Oct. 1, Effort Certification Forms (ECFs) will be generated via Insight and all effort managers will receive a system generated email notification. These forms must be completed within 30 days. • If you need a refresher on the effort reporting process please refer to the Effort Training Page on the RM Website. Other resources include: • Effort Reporting FAQs • Effort Reporting Quick Guide for Administrators • Effort Reporting Hierarchy Maintenance Quick Guide • Effort Reporting Guide for Investigators • Suggested steps to take in order to prepare for the reporting period include: • Make sure your Hierarchy is up to date and all investigators are listed. • Make sure your department contacts are up to date in the “Research Contacts” table in Insight • Ensure your department/unit assignment is up to date in the Admin tab in Insight • Work with your Post-Award Grant Administrator to ensure sponsor commitments are reflected correctly in InfoEd • Work with Post-Award to process any Employee Data Changes as necessary (must be complete prior to published deadlines for September in order to be reflected on ECFs) • If an investigator has left during the period or will be on an approved leave of absence, identify a suitable delegate and contact the Effort Team for set up

35. FY12 Pd 2 Effort Certification Deadlines • INITIAL NOTIFICATION • October 1- Primary Effort Managers (cc: Dept Admin) for investigators who had an ECF generated • EMAIL REMINDERS • October 10– Reminder to Primary Effort Managers for investigators who had an ECF generated so that investigators have enough time to certify • October 17– Reminder to Primary Effort Managers and Investigators who don’t have their forms completed • October 25– Final reminder to Department Administrators, Primary Effort Managers, and Investigators who don’t have their forms completed • DEADLINE • October 31 Deadline for effort reports return (marked as completed in Insight) • ESCALATION • November 15– Chief, Dept Admin, Institutional Research Administrator, and Entity Compliance Officer • November 30–Entity VP Research, PHS Corporate Director RM and RF, PHS Compliance Officer, PHS Director of Research Analytics & Reporting + everyone above • December 14– PHS VP Finance + everyone above • CERTIFICATION PERIOD CLOSE • March 30– Last day to electronically sign Period 2 effort reports in Insight; paper-based on April 1

36. Compliance Update: Late Cost Transfers Top financial compliance issues: • Failure to allocate costs appropriately among grants – direct benefit test • Failure to allocate costs on a timely basis – wait until last year of the award and just before final invoice • Failure to initiate or adjust salary allocations on a timely basis All of the above typically translates to: Late Cost Transfers! • Significant compliance and financial risks! • In violation of Partners and NIH policies (90-day-rule) • Lack of controls • Compromised LOC draw • Prime challenging & possibly rejecting sub invoice

37. PHS Corporate Research Offices Survey First full, comprehensive Partners Corp. Research Offices survey (https://www.surveymonkey.com/s/PHSCorporateResearchSurveytoPHSCustomers): Aimed at Department Administrators but all feedback welcome Feedback to help prioritize FY13 initiatives, and focus improvements to better meet the needs of the research community Survey communicated via RM Message & direct email to DAs week of 9/10; Survey closes 9/21 15 research work areas- lengthy but can bypass areas you don’t interact with; “save & return” functionality if cookies enabled Senior Leaders and directors develop action plans based on results, submit final action plans to Markell/Dr. Klibanski by 10/26 Complete survey = Reception for research community sharing high level themes and I-Pad raffles 10/29, Sheraton Boston, 5-7pm Issues: researchfeedback@partners.org 37

38. PCRO PD Implementation

39. PCRO PD Training at McLean Partners Clinical Research Office (PCRO) is offering a training session for the new InfoEd PCRO Proposal Development process.  The roll out will officially occur on September 21st.  The system is used as a submission tool so if you work or anticipate working on industry sponsored clinical research, it is important that you attend this training. The old process will be completely eliminated at the aforementioned date. Training session: Friday, September 21, 2pm – 3pm, Pierce Hall

40. PCRO PD Highlights • Used as a submission tool for new industry sponsored clinical research agreements and gifts • Not used for amendments, subcontracts or CDA’s • New proposal triage selection for PCRO or RM Pre-Award Team leading to different set up pages • PCRO continues to handle budget entry / fund activation for PCRO agreements • Electronic coversheet moved to the front of the process (required for PCRO submission) with separate electronic chief budget approval upon budget negotiation/review completion • PI Questionnaire changed to E-form • Changes in required submission documents • PCRO will approve or deny submissions to begin contract and budget negotiation/review based on completion of required documents

41. PCRO PDvs Grants & Contracts PD Grants & Contracts • Proposal Set Up Questions • Budgeting Module • Attachment Upload Interface • Partners Electronic Coversheet • eCOI Functionality • Electronic Routing Process • PCRO • Proposal Set Up Questions • Attachment Upload Interface • Partners Electronic Coversheet • Electronic Routing Process

42. PCRO Industry Pre-Award PD Process PI/Dept proposal entry and completion of required documents/forms PCRO Agreement Execution and Fund Activation PI/DA/Chief Approval for PCRO submission Chief electronic budget approval PCRO approves Complete submission Project Submission PCRO Contract Negotiation / Budget Review PCRO denies Incomplete submission PD Submission PCRO Proposal Management in PT

43. PCRO PD Submission Approval Process PCRO Submission Approval Process is equal to “Routing” Process for RM Pre-Award • Proposal is locked down pending PI and Chief approval • At each stage, users have ability to approve or decline as well as add comments that are reported to the PI

44. Submission Documents *Required • Partners Cover Sheet* • Final Principal Investigator Questionnaire (PIQ) *– Conflict of interest form(s) * • Draft contract* (preferably Word version) • Final protocol (draft acceptable for submission) or final scope of work agreed to with the sponsor* • Draft budget (if separate from contract and preferably Excel version) • Draft Partners informed consent • Email correspondence and sponsor contact information IDE and PMA/510k carotid stent trials additionally require: • FDA letter for IDE or PMA/510k device (as applicable) • Device pricing (as applicable)

45. Benefits • Electronic documents & signatures - Elimination of hard copy forms/routing and outdated document versions • PIQ • Coversheet • Electronic chief budget approval - Future enhancement • Standardized process for incoming agreements • Reportable and more accurate incoming proposal data for PCRO turnaround measures • Greater efficiency in PCRO work performance management • Chief approval required for submission • Document requirement changes focus on project readiness to prioritize workload

46. PCRO PD Implementation • Departmental Feedback Sessions – solicit feedback for current PCRO PD design - completed • Process Review / Training – 1 hour walkthrough of PCRO PD submission – in progress • Communication and outreach - now through September 21 • Rollout – September 21 • Future Enhancement, budget approval deliverable

47. New InfoEd Screen – 1st screen

48. New InfoEd Screen – Upload Docs PCRO Req. docs Add PIQ form PCRO PIQ form

49. New InfoEd Screen – PCRO Submission Submit to Routing

50. PCRO PD Contacts • For technical questions: • esubmissions@partners.org • For business process questions: • Megan Hunt, Partners Clinical Research Office mhunt@partners.org 617-954-9371