FISMA in Federal Contracts: What to do Who can help. Rachel Rice Ackman MGH Research Compliance Office

Transcription

1 FISMA in Federal Contracts: What to do Who can help Rachel Rice Ackman MGH Research Compliance Office

2 What is FISMA? Federal Information Security Management Act Federal law involving specific Information Security (IS) requirements Only some federal contracts (not grants) The federal agency makes the determination to include FISMA terms in a contract Involving the collection of PHI in certain circumstances

3 How do I know if FISMA applies to my contract? Check your proposal guidelines, RFA, RFP If you are applying for a federal contract Check your awarded contract terms Partners Research Compliance is asking RM staff to check as well Keywords: FISMA, FAR Clause , or HHSAR Clauses through

4 What do I do if FISMA applies? Partners FISMA SOP: phrmresources/c/issr/pages/information- Systems-Security-Requirements.aspx

5 Key things to know 1. Additional administrative and IS requirements Employee roster and background checks, annual IS technical reports, additional technical security 2. Budget for the cost of compliance Partners Research IT Core will assist with the technical security and reporting 3. Plan for the time required to complete reports Some projects require submission of technical reports or certification with the proposal or within a short period after award

6 Contact Info Partners Research IT Core MGH Research Compliance Mary Gervino Director of MGH Research Compliance Rachel Ackman Sr. Research Compliance Associate Pamela Richtmyer Research Compliance Associate Compliance Helpline rg/research_compliance/rese archcompliancehome.aspx

7 Mary Gervino Director of MGH Research Compliance Rachel Ackman Sr. Research Compliance Associate Pamela Richtmyer Research Compliance Associate Compliance Helpline px

8 OnCore Clinical Trial Management System May 10, 2016 MGH RADG John Montana, Director, CTMS Partners Clinical Trial Office

9 Why a Clinical Trial Management System? Despite being international leaders in clinical research, Partners-affiliated hospitals have gaps in clinical trial management capabilities: Revenue. Partners-affiliated hospitals are not collecting all the revenue from industrysponsored clinical trials that is due to them Invoicing: Sites struggle with timely and accurate invoicing, as they are dependent on limited, internal staff resources No invoicing SOPs or templates; only department-/pi-level, home-grown solutions exist Payment tracking: Payments made without sufficient identifiers, lost payments, and incorrectly deposited payments are a regular issue for studies Trial Registry. There is no central registry for industry-funded clinical trials at Partners Electronic Data Capture. While there are survey tools available to PIs, there is no Partners-based EDC system for capturing study data Regulatory. Documentation scattered across multiple systems Biosample Tracking. No single system exists for tracking and managing biosamples Clinical Trial Management Systems offer enterprise-wide, standardized solutions to these common issues

10 Timeline to a CTMS January 2014 Began RFP Process (Ravi Thadhani under auspices of Partners Chief Academic Officer) Spring 2014 Selected OnCore CTMS (Faculty and staff from MGH, BWH, SRH, McLean and Partners participated in the vetting process) Spring 2015 CTMS Project Approved Internally December 2015 OnCore Contract Signed OnCore implementation is underway!

11 Phase I goals Trial Registration and Subject Tracking Centralized registration system for protocols Subject records linked to patient records in Epic Tools for tracking of subject visit progression Revenue Recovery Automated finances based on subject tracking Consistency in invoicing Improved accounts receivable Currently, Partners-affiliated hospitals are not collecting all the revenue from industrysponsor clinical trials that is due to them Enterprise Reporting Dashboards of clinical trial activity PHS-wide Detailed reporting on trial efforts by hospital, disease area, study type, etc. Reporting on enrollment efforts Customer Leadership

12 Long-term (subsequent phases) Goals Electronic Data Capture & ecrf Regulatory Biospecimen Management EDC solutions. Currently, study teams utilize homegrown solutions (Excel) without standardization Tools for generating ecrfs Centralized repository for regulatory documentation and management. Currently, documentation scattered across multiple systems Tracking research specimens. Currently, no system exists for tracking and managing biosamples Customer Leadership

13 CTO Implementing Extremely Aggressive Timeline for OnCore Phase 1 Rollout Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16 Sep-16 Oct-16 Nov-16 Phase I Initial Users Administration Hardware purchase OnCore installation CTMS staffing Kick-off meeting Immersion training Subject Management Configuration Testing/Training Go-live Protocol Management Configuration Testing/Training Go-live Financials Configuration Testing/Training Go-live Target go-live: October 2016

14 To Learn More About OnCore Please join us for an overview of the OnCore clinical trial management system and its implementation at MGH. Tuesday, June 7 th at noon O Keeffe Auditorium Or contact John Montana CTMS Director, Partners Clinical Trial Office jmontana@partners.org

15 Enterprise Research Infrastructure & Services (ERIS) elab Notebook (ELN) RFI Process Status Update Goal: ERIS to evaluate the addition of ELN option(s) to the suite of EDC tools: REDCap, LimeSurvey, StudyTRAX, Freezerworks Milestones: 03/2014 General ELN Survey to Research Community 10/2015 Discussion with Research Leadership regarding evaluation 12/07/2015 Request for Information (RFI) issued to 10 Vendors 01/22/2016 Vendor RFI Response Deadline 6 Vendor Responses 02/15/2016 3/04/2016 Vendor Selection for Presentations & Product Demos 03/16/2016 3/18/2016: On Site Round Table Discussions for Researchers to provide feedback: MGH, BWH, MCL & SPH 5/2016 7/2016: Pilot LabArchives / Early Adopter Program 12 Labs Interested; Approx 160 Users Registration Open: rc.partners.org/eln/earlyadopter JOIN the ELN Discussion Group rc.partners.org/eln 15

16 SAS Licensing Available for Researchers The Research Computing Core is selling SAS licenses for research. Cost: $400 per license annually ( expire April 29, 2017). No prorating. Request a new license rc.partners.org/sas-license-request You may order up to five licenses with this form Renewal If you haven t already done so, follow the instructions sent by or contact rcc@partners.org Website: rc.partners.org/sas SAS PC Licenses Individual install, one computer 9.3 or 9.4 Does not require Contact: rcc@partners.org SAS Server Licenses Access SAS from multiple devices 9.4 Requires Partners Network or VPN Access from Mac or Linux device (SAS Studio Interface) Please see the comparison chart on the website for details about both options.

17 Register for Partners Office for International Professionals and Students (PIPS) Introduction to Visas Presentation The "Introduction to Visas" presentation is intended for: Administrators who are new to coordinating/managing visa requests for their department Lab managers, Principal Investigators, and human resources representatives who would like general visa information Administrators who have been coordinating/managing visas, and would like to refresh their visa knowledge

18 Register for PIPS Introduction to Visas Presentation Date: Tuesday, May 17, 2016 Time: 1:45PM-4:30PM Location: BWH Carrie Hall Registration: Click here to register Date: Tuesday, May 24, 2016 Time: 1:30PM-5:00PM Location: MGH Haber Auditorium Registration: Click here to register

19 Register for PIPS Introduction to Visas Presentation Once registered, you are welcome to attend any part(s): Part 1: Visa Basics Responsibilities/roles of PIPS and your hospital department Identify and understand visa documents (I-94, DS-2019, I-797, visa stamp) Part 2: Visa Selection Use of Business/Observer Visas Compare J-1 and H-1B visas When to prepare a change of visa status from J-1 to H-1B Part 3: Questions & Answers Q&A Session: visa questions and open discussion

20 Suggestion of the Month Suggestion: Create a standardized T32 appointment spreadsheet to avoid all over/ under payments of these stipends (biz days v.s total days in month) mid month appts and early terms are all valid issues that we need transparency on. No reason to have department do calculations, for HR then for RM to review and recalculate and then for finance to revise and ask for retro changes. Should be done proactively and uploaded to the record. Impact: Manually this process would take 30 minutes, per person on a T-32 grant, per month. With the calculator, this process takes less than 5 minutes, and eliminates room for error. Matthew Mues, Center for Systems Biology

21 Web Portal

22 The Mass General Research Institute is: A community of 8,000 people working every day to improve healthcare 2,000 principal investigators leading research teams 3,700 scientists and research staff 1,500 research fellows training at Mass General 700 research administrative support staff Over 30 Departments, Centers and Institutes An annual research budget of $800M in FY15 Over 1.2 M square feet of research space Over 620 new patents filed last year Over 1200 active clinical trials 1/3 of all MGH clinicians are involved in research United by Research. Driven by Hope.