Exhibit 300 (BY2010) for NIH CC Clinical Research Information System (CRIS)

1. Date of Submission:

2009-03-12

2. Agency:

009

3. Bureau:

25

4. Name of this Capital Asset:

NIH CC Clinical Research Information System (CRIS)

5. Unique Project Identifier:

009-25-01-02-01-3006-00

6. What kind of investment will this be in FY2010?

Operations and Maintenance

7. What was the first budget year this investment was submitted to OMB?

FY2002

8. Provide a brief summary and justification for this investment, including a brief description of how this closes in part or in whole an identified agency performance gap.

The Clinical Research Information System (CRIS) was designed and implemented to support medical care and research support at the NIH Clinical Center. As the nation's largest research hospital, data collection and analysis for clinical trials is critical to improving the health of the nation. The CRIS supports over 1200 clinical trials at the hospital for the NIH through an enterprise of interfaced applications. As CRIS enters the O & M phase, the vision of multiple interfaced COTS systems is complete: The modules currently in production include: The hospital information core, radiology, nutrition, surgery, scheduling and admissions, Lab, transfusion medicine,EKG, Pharmacy, and Data Mart systems. Replacing a 25 year old legacy system, CRIS now offers a central source of data, images and reports for clinical researchers of the NIH intramural program. The project has mitigated the manual transfer of data, and has created electronic access to clinical and research data. The CRIS has been developed to meet multiple goals of the PMA. The key PMA is the e-government initiative. Clinical and research data including images are now ordered, documented and stored electronically. This has been critical to sustaining the research enterprise at the NIH, and allowed researchers access to larger datasets than in the past. A second PMA goal of human capital is also been addressed with this project. With the nursing shortage and decreased funding, there is decreased staffing. Therefore, the clinical care areas require efficient data capture into a system that accrues data once for care and for research. The CRIS system has reduced time for M.D.'s to enter orders (see performance measures) and also to make care decisions. This system has increased employee satisfaction with an electronic medical record system (see performance measures). The last PMA is R & D investment criteria. The core mission of the NIH is research. CRIS has enabled the intramural program to pool all patient data into one repository creating efficiencies and allowing researchers to analyze increasingly more complex data and results by protocol or across protocols. CRIS continues to meet goals set through a rigorous CPIC process. Budget requests are vetted through the project Steering Committee, the NIH IT Working Group, and evaluated through the NIH Budget and Management Working Group. CRIS became Steady in State with the begining of Fiscal Year 2007.

9. Did the Agency's Executive/Investment Committee approve this request?

yes

9.a. If "yes," what was the date of this approval?

2007-06-26

10. Did the Project Manager review this Exhibit?

yes

11.a. What is the current FAC-P/PM certification level of the project/program manager?

Waiver Issued

11.b. When was the Program/Project Manager Assigned?

2008-03-07

11.c. What date did the Program/Project Manager receive the FACP/PM certification? If the certification has not been issued, what is the anticipated date for certification?

2009-07-31

12. Has the agency developed and/or promoted cost effective, energy-efficient and environmentally sustainable techniques or practices for this project.

yes

12.a. Will this investment include electronic assets (including computers)?

yes

12.b. Is this investment for new construction or major retrofit of a Federal building or facility? (answer applicable to non-IT assets only)

no

13. Does this investment directly support one of the PMA initiatives?

yes

If yes, select the initiatives that apply:

Initiative Name
Expanded E-Government
Human Capital

13.a. Briefly and specifically describe for each selected how this asset directly supports the identified initiative(s)? (e.g. If E-Gov is selected, is it an approved shared service provider or the managing partner?)

CRIS supports the NIH electronic patient & research record. The PMA e-government initiative is supported directly with the creation of an electronic medical record and the creation of standardized databases that will be Interoperable with other medical information systems and allow for data-sharing across government & private health care providers.

14. Does this investment support a program assessed using the Program Assessment Rating Tool (PART)?

yes

14.a. If yes, does this investment address a weakness found during the PART review?

no

14.b. If yes, what is the name of the PARTed program?

10003522 - National Institutes of Health - Intramural Research

14.c. If yes, what rating did the PART receive?

Effective

15. Is this investment for information technology?

yes

16. What is the level of the IT Project (per CIO Council's PM Guidance)?

Level 2

17. What project management qualifications does the Project Manager have? (per CIO Council's PM Guidance)

(4) Project manager assigned but qualification status review has not yet started

18. Is this investment identified as high risk on the Q4 - FY 2007 agency high risk report (per OMB memorandum M-05-23)?

no

19. Is this a financial management system?

no

20. What is the percentage breakout for the total FY2009 funding request for the following? (This should total 100%)

Area	Percentage
Hardware	0
Software	0
Services	100
Other	0

21. If this project produces information dissemination products for the public, are these products published to the Internet in conformance with OMB Memorandum 05-04 and included in your agency inventory, schedules and priorities?

n/a

22. Contact information of individual responsible for privacy related questions.

Name	Karen Pla
Phone Number	301-402-6201
Title	NIH Privacy Act Officer
Email	plak@mail.nih.gov

23. Are the records produced by this investment appropriately scheduled with the National Archives and Records Administration's approval?

yes

24. Does this investment directly support one of the GAO High Risk Areas?

no

1. Provide the total estimated life-cycle cost for this investment by completing the following table. All amounts represent budget authority in millions, and are rounded to three decimal places. Federal personnel costs should be included only in the row designated Government FTE Cost, and should be excluded from the amounts shown for Planning, Full Acquisition, and Operation/Maintenance. The total estimated annual cost of the investment is the sum of costs for Planning, Full Acquisition, and Operation/Maintenance. For Federal buildings and facilities, life-cycle costs should include long term energy, environmental, decommissioning, and/or restoration costs. The costs associated with the entire life-cycle of the investment should be included in this report.

All amounts represent Budget Authority

Note: For the cross-agency investments, this table should include all funding (both managing partner and partner agencies).

Government FTE Costs should not be included as part of the TOTAL represented.

Cost Type	Py-1 & Earlier -2007	PY 2008	CY 2009	BY 2010
Planning Budgetary Resources	4.180	0.000	0.000	0.000
Acquisition Budgetary Resources	55.484	0.000	0.000	0.000
Maintenance Budgetary Resources	10.825	7.140	3.380	5.570
Government FTE Cost	16.730	3.250	3.520	3.740
# of FTEs	38	30	30	30

2. Will this project require the agency to hire additional FTE's?

no

In order to successfully address this area of the exhibit 300, performance goals must be provided for the agency and be linked to the annual performance plan. The investment must discuss the agency's mission and strategic goals, and performance measures (indicators) must be provided. These goals need to map to the gap in the agency's strategic goals and objectives this investment is designed to fill. They are the internal and external performance benefits this investment is expected to deliver to the agency (e.g., improve efficiency by 60 percent, increase citizen participation by 300 percent a year to achieve an overall citizen participation rate of 75 percent by FY 2xxx, etc.). The goals must be clearly measurable investment outcomes, and if applicable, investment outputs. They do not include the completion date of the module, milestones, or investment, or general goals, such as, significant, better, improved that do not have a quantitative measure.

Agencies must use the following table to report performance goals and measures for the major investment and use the Federal Enterprise Architecture (FEA) Performance Reference Model (PRM). Map all Measurement Indicators to the corresponding Measurement Area and Measurement Grouping identified in the PRM. There should be at least one Measurement Indicator for each of the four different Measurement Areas (for each fiscal year). The PRM is available at www.egov.gov. The table can be extended to include performance measures for years beyond FY 2009.

Row	Fiscal Year	Strategic Goal Supported	Measurement Area	Measurement Grouping	Measurement Indicator	Baseline	Planned Improvement to the Baseline	Actual Results
1	2006	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Service Efficiency	Prescriber electronic order entry time	05 results - 34.11 min +/- 8.14 minutes	29 minutes	Multiple order entry took 21.2 minutes, entry of same orders using order sets took 15.5 minutes, a decrease of 27%. Demonstrated efficiencies in creating order sets for patient care and research.
2	2006	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Errors	Number of missing lab specib specimens	Lost or missing lab specimens - 52 per year	39 less missing specimens	Decreased from 52 to 21 lost or mislabeled specimens, a decrease of 60%
3	2006	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Health Care Research and Practitioner Education	Perceived Usefulness, Perceived Ease of Use , Support of Clinical Care, Support Research, Customer Support, Training Satisfaction	Perceived usefulness - 52 %, Perceived Ease of Use 46%, Support of Clinical Care - 74%, Support Research 74%, Customer Support - 75%, Training satisfaction - 94%	Improve user satisfaction and ease of use of the medical information system by 10%	Perceived Usefulness - 73% (up 21%), Preceived Ease of Use - 57% (Up 11%), Support of Clinical Care - 85% (Increased 11%), Support Research - 78% (increased 4%), Customer Support - 85% (increased 10%), Training Satisfaction - 96% (increased 2%)
4	2006	Effective Management of Human Capital/Information Technology/Resources	Technology	Interoperability	Number of interface systems	At beginning of project had 5 interfaced systems	6	Built and interfaced scheduling system, surgery system, ADT system
5	2007	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Errors	Percentage use of physician order entry	05 results - 66.3 % of all orders	70%	Percentage of use 66.6% normal orders 77% medication orders
6	2007	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Automation	Number of protocol order sets	Count of protocol order sets	Increase number of order sets by 10%	Protocol order sets added 256
7	2007	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Health Care Research and Practitioner Education	Perceived Usefulness, Perceived Ease of Use , Support of Clinical Care, Support Research, Customer Support, Training Satisfaction	Perceived usefulness - 73%, Perceived Ease of use - 57%, Support of Clinical Care - 85%, Support of Research - 78%, Customer Support - 85%, Training Satisfaction - 96%.	Increase user satisfaction with system across all measures by 5%	Perceived usefulness 77% (up .6%)
8	2007	Effective Management of Human Capital/Information Technology/Resources	Technology	Interoperability	Number of interface systems	5	6	Added EKG and ProVation
9	2008	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Health Care Research and Practitioner Education	Perceived Usefulness, Perceived Ease of Use , Support of Clinical Care, Support Research, Customer Support, Training Satisfaction	Use prior year results as baseline	Increase by 5%	Perceived usefulness 88% up 9%
10	2008	Effective Management of Human Capital/Information Technology/Resources	Technology	Interoperability	Number of NIH systems interfaced to CRIS to improve efficiency	Use prior year results as baseline	Increase by 1	Added CRIMSON and Theradoc
11	2008	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Automation	Percent of auditors satified with electronic medical record	Currently auditors request paper medical record	100%	100%
12	2008	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Errors	Number of systems using barcoding to decrease patient errors (lab, pharmacy, blood bank)	In FY 06 only lab has barcoding system	3	Lab, DTM, & Pharmacy use Barcoding
13	2009	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Health Care Research and Practitioner Education	% of users indicating CRIS supports their health research at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	80% at 4 and above	Survey is released in June
14	2009	Effective Management of Human Capital/Information Technology/Resources	Technology	IT Contribution to Process, Customer, or Mission	% of users indicating CRIS' usefullness in their work is at the 4 and above levels on a scales from 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	75% at 4 and above	Survey is released in June
15	2009	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Access	% of users indicating CRIS' ease of use is at the 4 or above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	60% at 4 and above	Survey is released in June
16	2009	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Innovation and Improvement	% of users indicating CRIS supports clinical care at the 4 and above levels on a scale of 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	88% at 4 and above	Survey is released in June
17	2010	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Health Care Research and Practitioner Education	% of users indicating CRIS supports their health research at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	80% at 4 and above	TBD
18	2010	Effective Management of Human Capital/Information Technology/Resources	Technology	IT Contribution to Process, Customer, or Mission	% of users indicating CRIS' usefulness in their work is at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	75% at 4 and above	TBD
19	2010	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Access	% of users indicating CRIS' ease of use is at 4 or above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	60% at 4 and above	TBD
20	2010	S.O. 1.2 - Increase health care service availability and accessibility	Processes and Activities	Innovation and Improvement	% of users indicating CRIS supports clinical care at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	88% at 4 and above	TBD
21	2011	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Health Care Research and Practitioner Education	% of users indicating CRIS supports their health research at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellect)	Use prior year results as baseline	85% at 4 and above	TBD
22	2011	Effective Management of Human Capital/Information Technology/Resources	Technology	IT Contribution to Process, Customer, or Mission	% of users indicating CRIS' usefullness in their work is at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	80% at 4 and above	TBD
23	2011	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Access	% of users indicating CRIS ease of use is at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	65% at 4 and above	TBD
24	2011	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Innovation and Improvement	% of users indicating CRIS supports clinical care at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	90% at 4 and above	TBD
25	2012	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Health Care Research and Practitioner Education	% of users indicating CRIS supports their health research at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	85% at 4 and above	TBD
26	2012	Effective Management of Human Capital/Information Technology/Resources	Technology	IT Contribution to Process, Customer, or Mission	% of users indicating CRIS' usefullness in their work is at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	80% at 4 and above	TBD
27	2012	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Access	% of users indicating CRIS' ease of use is at the 4 or above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	65% at 4 and above	TBD
28	2012	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Innovation and Improvement	% of users indicating CRIS supports clinical care at the 4 and above levels on a scale of 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	90% at 4 and above	TBD
29	2013	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Health Care Research and Practitioner Education	% of users indicating CRIS supports their health research at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year results as baseline	85% at 4 and above	TBD
30	2013	Effective Management of Human Capital/Information Technology/Resources	Technology	IT Contribution to Process, Customer, or Mission	% of users indicating CRIS' usefullness in their work is at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year result as baseline	80% at 4 and above	TBD
31	2013	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Access	% of users indicating CRIS' ease of use is at the 4 or above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year result as baseline	65% at 4 and above	TBD
32	2013	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Innovation and Improvement	% of users indicating CRIS supports clinical care at the 4 and above levels on a scale of 1(unacceptable) to 5 (excellent)	Use prior year result as baseline	90% at 4 and above	TBD
33	2014	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Health Care Research and Practitioner Education	% of users indicating CRIS supports their health research at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year result as baseline	85% at 4 and above	TBD
34	2014	Effective Management of Human Capital/Information Technology/Resources	Technology	IT Contribution to Process, Customer, or Mission	% of users indicating CRIS' usefullness in their work is at the 4 and above levels on a scale of 1 (unacceptable) to 5 (excellent)	Use prior year result as baseline	80% at 4 and above	TBD
35	2014	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Access	% of users indicating CRIS' ease of use is at the 4 or above levels on a scale from 1 (unacceptable) to 5 (excellent)	Use prior year result as baseline	65% at 4 and above	TBD
36	2014	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Innovation and Improvement	% of users indicating CRIS supports clinical care at the 4 or above levels on a scale of 1 (unacceptable) to 5 (excellent)	Use prior year result as baseline	90% at 4 and above	TBD

In order to successfully address this area of the business case and capital asset plan you must ensure the investment is included in the agency's EA and Capital Planning and Investment Control (CPIC) process, and is mapped to and supports the FEA. You must also ensure the business case demonstrates the relationship between the investment and the business, performance, data, services, application, and technology layers of the agency's EA.

1. Is this investment included in your agency's target enterprise architecture?

yes

2. Is this investment included in the agency's EA Transition Strategy?

yes

2.a. If yes, provide the investment name as identified in the Transition Strategy provided in the agency's most recent annual EA Assessment.

NIH CC Clinical Research Information System (CRIS)

3. Is this investment identified in a completed (contains a target architecture) and approved segment architecture?

no

4. Identify the service components funded by this major IT investment (e.g., knowledge management, content management, customer relationship management, etc.). Provide this information in the format of the following table. For detailed guidance regarding components, please refer to http://www.whitehouse.gov/omb/egov/.

Component: Use existing SRM Components or identify as NEW. A NEW component is one not already identified as a service component in the FEA SRM.

Reused Name and UPI: A reused component is one being funded by another investment, but being used by this investment. Rather than answer yes or no, identify the reused service component funded by the other investment and identify the other investment using the Unique Project Identifier (UPI) code from the OMB Ex 300 or Ex 53 submission.

Internal or External Reuse?: Internal reuse is within an agency. For example, one agency within a department is reusing a service component provided by another agency within the same department. External reuse is one agency within a department reusing a service component provided by another agency in another department. A good example of this is an E-Gov initiative service being reused by multiple organizations across the federal government.

Funding Percentage: Please provide the percentage of the BY requested funding amount used for each service component listed in the table. If external, provide the funding level transferred to another agency to pay for the service.

Row	Agency Component Name	Agency Component Description	Service Type	Component	Reused Component Name	Reused UPI	Internal or External Reuse?	Funding %
1	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Routing and Scheduling	Outbound Correspondence Management			No Reuse	8
2	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Knowledge Management	Categorization			No Reuse	4
3	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Routing and Scheduling	Inbound Correspondence Management			No Reuse	0
4	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Visualization	Graphing / Charting			No Reuse	3
5	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Asset / Materials Management	Computers / Automation Management			No Reuse	4
6	NIH IT Infrastructure	The NIH IT Infrastructure program consists of network infrastructure, cyber security, office automation, help desk support, and telecommunications for all of NIH. These tools are used by internal and external researchers, patients, and the public.	Security Management	Digital Signature Management	Digital Signature Management	009-25-02-00-01-3109-00	Internal	0
7	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Development and Integration	Data Integration			No Reuse	2
8	NIH IT Infrastructure	The NIH IT Infrastructure program consists of network infrastructure, cyber security, office automation, help desk support, and telecommunications for all of NIH. These tools are used by internal and external researchers, patients, and the public.	Security Management	Intrusion Prevention	Intrusion Prevention	009-25-02-00-01-3109-00	Internal	9
9	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Data Management	Data Warehouse			No Reuse	9
10	NIH IT Infrastructure	The NIH IT Infrastructure program consists of network infrastructure, cyber security, office automation, help desk support, and telecommunications for all of NIH. These tools are used by internal and external researchers, patients, and the public.	Organizational Management	Network Management	Network Management	009-25-02-00-01-3109-00	Internal	0
11	NIH IT Infrastructure	The NIH IT Infrastructure program consists of network infrastructure, cyber security, office automation, help desk support, and telecommunications for all of NIH. These tools are used by internal and external researchers, patients, and the public.	Management of Processes	Configuration Management	Configuration Management	009-25-02-00-01-3109-00	Internal	4
12	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Tracking and Workflow	Process Tracking			No Reuse	3
13	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Knowledge Management	Information Retrieval			No Reuse	5
14	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Development and Integration	Enterprise Application Integration			No Reuse	9
15	NIH IT Infrastructure	The NIH IT Infrastructure program consists of network infrastructure, cyber security, office automation, help desk support, and telecommunications for all of NIH. These tools are used by internal and external researchers, patients, and the public.	Security Management	Identification and Authentication	Identification and Authentication	009-25-02-00-01-3109-00	Internal	0
16	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Knowledge Management	Information Sharing			No Reuse	4
17	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Management of Processes	Business Rule Management			No Reuse	2
18	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Knowledge Management	Information Mapping / Taxonomy			No Reuse	11
19	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Reporting	Standardized / Canned			No Reuse	0
20	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Management of Processes	Quality Management			No Reuse	2
21	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Systems Management	Remote Systems Control			No Reuse	5
22	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Reporting	Ad Hoc			No Reuse	3
23	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Organizational Management	Network Management			No Reuse	0
24	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Systems Management	Issue Tracking			No Reuse	6
25	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Records Management	Document Classification			No Reuse	4
26	NIH CC Clinical Research Information System (CRIS)	CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition.	Knowledge Management	Knowledge Distribution and Delivery			No Reuse	3

5. To demonstrate how this major IT investment aligns with the FEA Technical Reference Model (TRM), please list the Service Areas, Categories, Standards, and Service Specifications supporting this IT investment.

FEA SRM Component: Service Components identified in the previous question should be entered in this column. Please enter multiple rows for FEA SRM Components supported by multiple TRM Service Specifications.

Service Specification: In the Service Specification field, Agencies should provide information on the specified technical standard or vendor product mapped to the FEA TRM Service Standard, including model or version numbers, as appropriate.

Row	SRM Component	>Service Area	Service Category	Service Standard	Service Specification (i.e., vendor and product name)
1	Outbound Correspondence Management	Service Access and Delivery	Access Channels	Collaboration / Communications	Microsoft Exchange by: Microsoft Corporation
2	Categorization	Service Platform and Infrastructure	Database / Storage	Database	Microsoft SQL Server by: Microsoft Corporation
3	Categorization	Component Framework	Data Management	Reporting and Analysis	Eclipsys Sunrise Clinical Manager by: Eclipsys
4	Inbound Correspondence Management	Service Access and Delivery	Access Channels	Collaboration / Communications	Microsoft Exchange by: Microsoft Corporation
5	Graphing / Charting	Component Framework	Data Management	Reporting and Analysis	Eclipsys Sunrise Clinical Manager by: Eclipsys
6	Computers / Automation Management	Service Platform and Infrastructure	Hardware / Infrastructure	Servers / Computers	Sun Server by: TBD
7	Computers / Automation Management	Service Platform and Infrastructure	Hardware / Infrastructure	Servers / Computers	IBM RISC by: IBM
8	Digital Signature Management	Service Access and Delivery	Service Transport	Supporting Network Services	SiteMinder, Netegrity by: CA, Inc.
9	Data Integration	Service Interface and Integration	Interoperability	Data Format / Classification	HL7 Messaging Standard Version 3.0 by: Health Level Seven, Inc.
10	Data Integration	Service Interface and Integration	Integration	Enterprise Application Integration	QDX Interface Engine by: QDX
11	Data Integration	Service Interface and Integration	Interoperability	Data Format / Classification	Microsoft Message Queuing by: Microsoft Corporation
12	Intrusion Prevention	Service Access and Delivery	Service Transport	Supporting Network Services	SiteMinder, Netegrity by: CA, Inc.
13	Data Warehouse	Service Interface and Integration	Integration	Middleware	Tivoli Storage Manager by: Tivoli
14	Data Warehouse	Service Platform and Infrastructure	Database / Storage	Storage	EMC SAN Products by: EMC Corporation
15	Data Warehouse	Service Platform and Infrastructure	Database / Storage	Database	Microsoft SQL Server by: Microsoft Corporation
16	Data Warehouse	Service Interface and Integration	Integration	Middleware	Quest Central by: TBD
17	Data Warehouse	Service Platform and Infrastructure	Database / Storage	Database	SYBASE 4D by: Sybase
18	Network Management	Service Platform and Infrastructure	Hardware / Infrastructure	Local Area Network (LAN)	Ethernet by: Institute of Electrical and Electronics Engineers
19	Network Management	Service Platform and Infrastructure	Hardware / Infrastructure	Servers / Computers	Microsoft Systems Management Server by: Microsoft Corporation
20	Network Management	Service Access and Delivery	Service Transport	Supporting Network Services	SiteMinder, Netegrity by: CA, Inc.
21	Configuration Management	Service Platform and Infrastructure	Hardware / Infrastructure	Servers / Computers	Microsoft Systems Management Server by: Microsoft Corporation
22	Configuration Management	Service Access and Delivery	Access Channels	Collaboration / Communications	BMC Remedy Service Management by: BMC Software, Inc.
23	Process Tracking	Component Framework	Data Management	Reporting and Analysis	Eclipsys Sunrise Clinical Manager by: Eclipsys
24	Information Retrieval	Service Access and Delivery	Access Channels	Web Browser	Windows Internet Explorer by: Microsoft Corporation
25	Enterprise Application Integration	Service Platform and Infrastructure	Delivery Servers	Web Servers	Apache by: Apache Software Foundation
26	Enterprise Application Integration	Service Interface and Integration	Integration	Enterprise Application Integration	Visual Studio 6.0 by: Microsoft Corporation
27	Enterprise Application Integration	Service Interface and Integration	Integration	Enterprise Application Integration	QDX Interface Engine by: QDX
28	Enterprise Application Integration	Service Platform and Infrastructure	Support Platforms	Dependent Platform	.NET 2.0 Framework by: Microsoft Corporation
29	Enterprise Application Integration	Component Framework	Data Management	Reporting and Analysis	Eclipsys Sunrise Clinical Manager by: Eclipsys
30	Enterprise Application Integration	Service Platform and Infrastructure	Software Engineering	Integrated Development Environment	Merant Collage by: Merant
31	Enterprise Application Integration	Component Framework	Data Management	Database Connectivity	Open Database Connectivity by: Microsoft Corporation
32	Enterprise Application Integration	Service Platform and Infrastructure	Delivery Servers	Web Servers	Microsoft Internet Information Services by: Microsoft Corporation
33	Enterprise Application Integration	Service Platform and Infrastructure	Delivery Servers	Application Servers	Orion Application Server by: TBD
34	Enterprise Application Integration	Service Platform and Infrastructure	Support Platforms	Independent Platform	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
35	Identification and Authentication	Service Access and Delivery	Service Requirements	Authentication / Single Sign-on	Microsoft Active Directory by: Microsoft Corporation
36	Identification and Authentication	Component Framework	Security	Supporting Security Services	Hypertext Transfer Protocol with SSL by: The Internet Engineering Task Force
37	Identification and Authentication	Component Framework	Data Interchange	Data Exchange	Lightweight Directory Access Protocol by: The Internet Engineering Task Force
38	Identification and Authentication	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
39	Identification and Authentication	Service Access and Delivery	Service Transport	Supporting Network Services	SiteMinder, Netegrity by: CA, Inc.
40	Information Sharing	Service Platform and Infrastructure	Database / Storage	Storage	EMC SAN Products by: EMC Corporation
41	Business Rule Management	Component Framework	Data Management	Reporting and Analysis	Eclipsys Sunrise Clinical Manager by: Eclipsys
42	Information Mapping / Taxonomy	Component Framework	Data Management	Reporting and Analysis	Eclipsys Sunrise Clinical Manager by: Eclipsys
43	Information Mapping / Taxonomy	Service Interface and Integration	Integration	Enterprise Application Integration	QDX Interface Engine by: QDX
44	Standardized / Canned	Service Platform and Infrastructure	Database / Storage	Database	Microsoft SQL Server by: Microsoft Corporation
45	Standardized / Canned	Component Framework	Data Management	Reporting and Analysis	Eclipsys Sunrise Clinical Manager by: Eclipsys
46	Quality Management	Service Platform and Infrastructure	Software Engineering	Test Management	Serena TeamTrack by: Serena
47	Remote Systems Control	Service Access and Delivery	Access Channels	Wireless / PDA	802.11g by: Institute of Electrical and Electronics Engineers
48	Ad Hoc	Service Interface and Integration	Integration	Middleware	Quest Central by: TBD
49	Ad Hoc	Component Framework	Data Management	Reporting and Analysis	Hummingbird BI Query Admin by: TBD
50	Ad Hoc	Component Framework	Data Management	Reporting and Analysis	Crystal Reports by: SAP AG
51	Ad Hoc	Service Platform and Infrastructure	Database / Storage	Database	Microsoft SQL Server by: Microsoft Corporation
52	Ad Hoc	Component Framework	Data Management	Reporting and Analysis	Eclipsys Sunrise Clinical Manager by: Eclipsys
53	Ad Hoc	Component Framework	Data Management	Reporting and Analysis	Surgical Information Systems by: TBD
54	Network Management	Service Access and Delivery	Delivery Channels	Intranet	Hypertext Transfer Protocol -- HTTP/1.1 by: The Internet Engineering Task Force
55	Network Management	Component Framework	Security	Supporting Security Services	Blue socket by: TBD
56	Network Management	Component Framework	Security	Supporting Security Services	Secure Sockets Layer by: Netscape Communications Corporation
57	Network Management	Service Platform and Infrastructure	Hardware / Infrastructure	Network Devices / Standards	CA Unicenter by: Computer Associates
58	Network Management	Service Access and Delivery	Service Transport	Supporting Network Services	SItescope by: TBD
59	Network Management	Service Access and Delivery	Service Transport	Supporting Network Services	TCP/IP by: The Internet Engineering Task Force

6. Will the application leverage existing components and/or applications across the Government (i.e., FirstGov, Pay.Gov, etc)?

no

You should perform a risk assessment during the early planning and initial concept phase of the investment's life-cycle, develop a risk-adjusted life-cycle cost estimate and a plan to eliminate, mitigate or manage risk, and be actively managing risk throughout the investment's life-cycle.

Answer the following questions to describe how you are managing investment risks.

1. Does the investment have a Risk Management Plan?

yes

1.a. If yes, what is the date of the plan?

2008-12-13

1.b. Has the Risk Management Plan been significantly changed since last year's submission to OMB?

no

2.b. If no, what is the strategy for managing the risks?

1. Was operational analysis conducted?

yes

1.a. If yes, provide the date the analysis was completed.

2008-12-13

What were the results of your operational analysis?

The first ORR was performed In August 2004 prior to the original go-live for CRIS CORE. In addition, before each of the ancillary go-lives, or Eclipsys upgrades, an Operational Readiness Review is also performed. This review typically consists of a checklist of readiness objectives that need to be achieved before the system go live, responsible staff member, date, etc. An Operational Analysis will be performed for the entire system each year covering costs, schedule and performance as requested by NIH management (the IT Working Group). As the system has moved into Steady State or Operations and Maintenance reviews are performed when there is a significant event such as a version upgrade. The reveiw consists of preplanning the activation, preperation of a go-live activation check list of tasks and the person or persons responsible for performing the tasks. Minor reviews are perfomed with the installation of vendor based "hot fixes" or other changes to the system. These are captured in our Configuration Management System through the use of System Change Requests or SCRS. We went live on version 5.0 on 12/13/2009.