Attachment_A-_JReview_TO_SOW_Final_20150721.docx

Attachment A:

Food and Drug Administration Statement of Work (SOW):

JReview Support Task Order (TO) One

Contents

1.

2. Background

The Center for Drug Evaluation and Research, Office of Translational Science, Office of Computational Science (CDER/OTS/OCS) established the Computational Science Center (CSC) to support the needs of the review community, their scientific review processes, and associated scientific computing efforts. In particular, the CSC is focused on changing how data from regulatory submissions are acquired, stored and analyzed in order to provide more quantitative-based decisions.

The JReview application is currently being used by CDER and the Center for Biologics Evaluation and Research (CBER) reviewers to tabulate, visualize, and analyze safety and efficacy data. Customers require enhanced, in-depth customer support to address complex questions and complex data. Although the FDA does not anticipate additional centers requesting access to the JReview application, this task order covers support for any customer with an FDA-assigned JReview account.

JReview provides regulatory reviewers the analytical tools necessary to enhance and modernize the review process. JReview is a server based Java application accessed by users through Java Web Start. JReview enables users to tabulate, visualize, and analyze safety and efficacy data for their reviews. JReview communicates to a Windows based C++ middle tier component which communicates with a C based Unix server module – which connects to either the SAS Share module to access SAS datasets (for the current FDA JReview SAS dataset production environment, or for accessing SAS datasets pulled from PORTES), or to an Oracle database via Oracle OCI function calls. PORTES is a SAS based drug development data store. CTR is a web accessible Oracle RDBMS.

3. Purpose

The purpose of this Task Order is to procure technical expertise and professional services to support the requirements listed in section 5 Task Area Requirements.

4. Objectives

Through this Task Order, the Government seeks to achieve the following objectives for JReview:

· Increase report creation, review and analysis efficiency

· Improve access to FDA Enterprise Architecture data sources

· Improve the JReview user experience 1.

2.

3.

5. Scope

The scope of this Task Order is to procure the following professional services:

1.

2.

3.

4.

5.

· Transition-In

· Project Management

· Operations and Maintenance

· Training

· Integration, Customization and Enhancement

· Metrics Reporting

6. Task Areas Requirements

2.

3.

4.

5.

6.

6.1. Transition In (Labor Hours)

The Contractor shall:

1. Develop and maintain Transition‐In Plan in order to provide an orderly transition of work activities, products and knowledge from the incumbent Contractor to the new JReview Contractor. The period of performance for the Transition In is 60 business days.

2. Deliver the final Transition In Plan to the Task Order Contract Officer Representative (COR) within 15 days of Task Order award. This plan shall identify and sequence the transfer of all activities from the incumbent Contractor. The transition plan shall include staffing plan/model, risks with mitigation strategy, schedule and communication activities.

3. Conduct a pre-kickoff meeting to review task order with COR. Conduct Task Order kick off meeting with key stakeholders that will include review and validation of the timeline and schedule subject to FDA approval for activities listed in this task order.

4. On-board all staff who will be providing transition support within 30 days of the Task Order award.

5. Provide all security documentation required to complete the security clearance process within 7 days of Task Order award.

6. Ensure no disruption to user’s ability to employ JReview

7. Participate in Transition In meetings.

8. Engage in regularly scheduled project meetings as described in this Task Order.

9. Participate in knowledge transfer activities such as “shadowing” incumbent Contractors.

10. Ensure staff identified as key personnel are available to work with Subject Matter Experts (SME) from the Government and the incumbent Contractor immediately after Task Order Award.

11. Within 45 days of an employee beginning work on this Task Order, certify to the COR that the employee has a complete understanding of the documented requirements, technical environment and current implementation plans and activities.

12. Attend transitional meetings at the locations indicated in the Meetings Table.

13. Create transitional deliverables in the Deliverables Table.

Meetings Table

And WebEx 2 per week during transition period

Deliverables Table

6.2. Project Management (Firm Fixed Price)

The Contractor shall provide a Program Manager to ensure the full functionality of all tasks under the JReview IDIQ. The Program Manager shall establish common management processes to ensure the quality, effectiveness and timely performance of all task orders under this IDIQ.

6.2.1. Contract Management Plan

The Contractor shall develop and continually update a Contract Management Plan that will document the processes across task orders for cross-task activities as well as process for each task order and its individual activities under the task order SOW to ensure clear communication, coordination and integration for the systems, applications and modules under all task orders.

6.2.2. Task Order Management

The Contractor shall:

1. Provide a Project Management Plan (PMP) to the COR that aligns with the FDA EPLC processes and documentation (see Attachment IDIQ02 – EPLC Agile Methodology Overview for Contractors and Attachment IDIQ03 – EPLC Waterfall Methodology Overview for Contractors). The Project Management Plan shall include:

1.1. Work Breakdown Structure with a project schedule to include milestones, organization chart identifying relationships, authorities and responsibilities.

1.2. Risk Management Plan, in accordance with the EPLC, that includes a log of project risks, impacts, likelihood, root causes, severity of impact, and mitigation.

2. Prepare materials for and participate in JReview meetings including Project reviews, stage gate reviews, team meetings, management briefings, stakeholder presentations, cross agency information exchanges and other similar meetings, as defined in this Task Order. The COR or COR designee will provide the dates, time, location and agenda of the meeting one day prior to the meeting.

3. Provide ad hoc COR-requested JReview documentation needed for data calls, management decisions and requests, and reporting. The Contractor shall consult with the COR or COR designee, such as the FDA JReview Project Manager for clarification of the documentation requirements. Examples of JReview documentation include:

3.1. Release Notes

3.2. Requests for Change

3.3. Help Desk Tickets

4. Attend Change Control Boards (e.g. infrastructure, desktop, firewall and application CCBs) when changes are planned that impact the JReview application or hardware. The Contractor shall complete all required forms, provide technical guidance on change assessments, and present changes to the board in accordance with FDA CCB Charter (Attachment IDIQ01). It is anticipated that the Contractor shall participate in 10-15 CCB Meetings and activities per year.

4.1.

4.2.

4.2.1.

5. Document procedures in accordance with FISMA regulations for the generation and review of audit records generated by JReview (The Federal Information Security Management Act (FISMA) ( section 3544(b)(2)(D)(iii) ) This includes:

5.1. Defining events/actions in JReview that require an audit record to be generated,

5.2. Defining where the audit records are to be written,

5.3. Developing a procedure for the regular reviewing of the generated audit records for evidence of unauthorized activity

6. Identify, create, submit and track through completion approximately 10-15 Request Quality Service & Technology from IT (RQST-IT) (as described below) requests and 10-15 requests for change (RFCs) per year for maintenance, releases, integration, and enhancements of JReview. RQST-IT is an FDA system that supports the business process for evaluating and tracking all new projects, configuration requests, assessments of new software, and software versions. RFCs and the RFC process are managed by FDA’s HP Service Manager.

7. Provide a Quality Assurance Plan (QAP) to the COR and COR designee for approval, covering all task areas in this Task Order. Once approved the Contractor shall implement the QAP. The QAP describes the scope, process, roles and responsibilities, performance requirements, and surveillance methods used in the administration of this Task Order.

8. Provide Monthly Status Report to the COR and COR designee for all tasks awarded under the IDIQ. This Status Report shall include:

8.1. Task Order Status

8.2. Cost and schedule progress and variances against the PMP

8.3. Significant risks to scheduled deliverables and plans to mitigate them

8.4. Issues and recommendations for escalation

8.5. Status of tickets and metrics against Service Level Agreements (SLAs)

8.6. Recommendations for changes or additional activities

8.7. Issues and recommendations for each task’s effect on other tasks within the IDIQ as well as integration points with other FDA programs.

9. The Contractor shall create and maintain the JReview Standard Operating Procedures (SOPs) in accordance with the EPLC. Examples of the SOPs include the User Guides and Customer Support Operations.

10. The Contractor shall prepare and maintain Security Documentation in accordance with FISMA requirements, including the System Security Plan (SSP) and Audit Record Review procedures.

Meetings Table Meeting/ Activity

6.3. Operations and Maintenance (O&M) (Firm Fixed Price)

The Contractor shall provide Operations and Maintenance services for JReview across all environments (test, training, production), and integration points with other systems. The Contractor shall ensure maximum availability (98% up time) of the JReview production system during each work day of the work week (Monday through Friday 8am-5:30pm).

The Contractor shall ensure O&M requirements apply to all components of JReview as previously defined in the IDIQ as well as to any other software that is needed for JReview’s implementation and integration with other data source systems such as PORTES SAS Drug Development and Clinical Trial Repository (CTR).

Historical experience can be used to guide the estimated workload in two areas, Customer Support and classroom hours for training. The following table presents the historical estimated workload for Customer Support. A table representing historical estimated workload for training is provided in the Training Task Area of this SOW. A total workload estimate for O&M and for training, respectively, shall include all subtasks described in the relevant sections, below.

Summary of Average Estimated Workload for Customer Support (historical figures)

The Contractor shall perform the following activities:

1. Perform routine maintenance of JReview:

1.1. Install upgrades, as available from the vendor, to the JReview application

1.2. Monitor and maintain the connectivity between JReview and PORTES (SAS Drug Development), and JReview and CTR (Clinical Trial Repository - Oracle)

1.3. Maintain approximately 600 user accounts per year, with an average of 60 active users monthly

1.4. Provide and maintain JReview-specific web pages. Web page examples may include a data load request form, web pages to find specific NDA (New Drug Application) studies (regardless of integration points), JReview training offerings and general JReview information web pages.

1.5. Update integration points as Janus CTR and PORTES data sources are enhanced.

1.6. Report all JReview-related hardware issues to FDA’s Employee Resource & Information Center (ERIC). The Contractor shall work through ERIC to resolve hardware-related issues

1.7. Perform the IT functions to ensure functionality of JReview in all environments as defined in section 4 “Technical Environment” of the IDIQ SOW. The Contractor shall provide technical and application assistance for individuals having technical problems with any portion of the JReview application. Technical support includes:

1.7.1. Technical support to users by researching and answering questions related to JReview; troubleshooting JReview problems; maintaining JReview application and server performance.

1.7.2. Guiding user through corrective steps.

1.7.3. Developing and maintaining the SOP that serves as the JReview User Guide.

1.7.4. Develop candidate fixes for the consideration of the Change Control Board (CCB) when the performance of JReview is not as expected, the Contractor shall develop candidate fixes for the consideration of the Change Control Board (CCB), in accordance with FDA CCB Charter (Attachment IDIQ01).

2. The Contractor shall, upon receipt of a ticket by the FDA ticketing system (HPSM – HP Service Manager), or a request by an end user, COR, or other FDA member of a JReview issue that cannot be resolved through Tier 0 or Tier 1 help, resolve the issue in accordance with the SLAs in the SLA Table below. For requests received outside of HPSM, the Contractor shall create a new HPSM ticket (See table above for historical averages). The Contractor shall include all details of customer request and resolution / solution in HPSM. If the issue cannot be resolved without a change to JReview, the Contractor shall develop candidate fixes for the consideration of the CCB in accordance with FDA CCB Charter (Attachment IDIQ01). FDA will provide Training Guide for HPSM at contract award.

3. Answer technical and application assistance requests that cannot be resolved by Tier 0 and Tier 1 support. Requests may take 2-3 hours per visit to complete. At least one member of the customer support team shall be present at FDA WO during the normal business hours as defined in the JReview IDIQ. Contractor shall work with OCS SMEs and reviewers in collaboration with Tier 0 and Tier 1 support staff to determine the root cause(s) of more complex problems. Contractor shall adjust to changes in customer support models and customer support delivery per COR direction.

4. Perform application patching impact analysis and release management in accordance with the Release Management section in this Task Order, as well as EPLC processes (Attachment IDIQ02 – EPLC Agile Methodology Overview for Contractors, and Attachment IDIQ03 – EPLC Waterfall Methodology Overview for Contractors), including obtaining all required approvals, prior to implementing an approved patch release in the production environment. Patch release activities include the following:

4.1. Test patches and upgrades to JReview, including supporting applications and integration points, in the maintenance/test/training/development environments.

4.2. Promote all successfully tested changes to production.

4.3. Re-install all associated software.

5. Schedule downtime of the production application, e.g. needed to implement a patch or perform O&M activities, at a minimum of two (2) weeks in advance of the work to be performed, with COR approval. The Contractor shall perform such work during off-hours (after 9pm Mon-Thurs until 4:30am of the respective following morning, after 9pm Fri, any time Sat-Sun, any time during a government holiday. All work shall be completed with system available by 6:30am Monday through Friday.)

6. If JReview goes down due to an unscheduled outage, the Contractor shall bring the application back on-line immediately after being aware of the outage. If a fix is needed, the Contractor shall inform the COR or COR designee of the need for an emergency fix and the recommended timeline for implementation. Upon COR or COR designee concurrence, the Contractor shall develop the necessary patches to fix JReview. The Contractor shall follow the release management process, in accordance with the EPLC, in development of the fix. The Contractor shall implement the fix in as timely a manner as possible (e.g. as soon as needed hardware is secured and the affected data center is available). This includes performing all activities associated with the fix during hours beyond the 8am-5:30pm M-F timeframes. The current state of the application is steady and the FDA anticipates few application outages.

7. Upon notification (e.g. via email from FDA) of, or scheduled activities during weekends, where FDA is performing planned Operating System (OS) patching, maintenance or other maintenance-based outages (like planned power outages), the Contractor shall monitor JReview performance and availability. The Contractor shall ensure the user’s ability to perform work on the JReview application as soon as FDA maintenance work is completed and inform the COR of JReview system status and availability. In situations where JReview application is no longer available due to a reboot or other technical failure caused by planned FDA outage, Contractor shall take steps to return JReview to normal operations.

Service Support Tiers The table below entitled “Service Support Tiered Levels” defines levels of support provided to application users.

Service Support Tiered Levels

Tier 0

Tier 0 refers to a collection of web resources that will permit the customer to attempt to solve a problem based on published knowledge. Tier 0 also empowers the customer to describe a non-urgent problem and submit a work ticket through the FDA’s websites.

Tier 1

Tier 1 refers to the services provided by OCS service and help desks.

Tier 2

Tier 2 refers to support provided when an issue cannot be resolved through Tier 0 & Tier 1 and is escalated to the JReview Contractor. The issue may require one of the following:

· On-site support by a trained technician / SME

· Experienced technical expertise

· Expertise in the technology causing the problem.

Standard FDA Service Level Agreements The table below entitled “Computer Support Service Level Agreement” describes issues severity levels, expected response times, and expected resolution times.

Computer Support Service Level Agreement

Examples: Multiple customers in building cannot log onto JReview or cannot access analyses

Examples: Individual customer cannot access JReview; customer’s account not operable

Examples: Customer's specific study of a BLA(Biologics Licensing Application)/NDA not found in the system

Examples: analyses is not printable, etc.

Source: Computer Support Service Level Agreement Effective 5/3/2010

Deliverables Table

Metrics Table

6.3.1. Change Management

The Contractor shall:

1. Present all candidate change, including enhancements and patches, to the COR or COR designee, and CCBs, unless the COR or COR designee has authorized an emergency fix. The Contractor shall work within the CCB process as defined in the FDA CCB Charter ((Attachment IDIQ01)) and 2) to identify the root cause of the issue being addressed, and determine whether it is a problem within the JReview system or from hardware, network or some other factor outside the scope of the JReview system. The Contractor shall identify a strategy and plan for fixing the problem, and identify the general nature of changes outside of JReview if any, necessary to fix the problem. The Contractor shall submit problem descriptions, root cause analyses, strategies and plans for fixes, and external changes that would be needed to the CCB. The Contractor shall work closely with the CCB to ensure the proper allocation of changes is made between those personnel within the JReview team and personnel external to the JReview team, the CCB will assign fixes as required to the Contractor. Upon COR approval, the Contractor shall fully correct the problem.

2. The FDA development environment is available for the Contractor to develop approved fixes. The Contractor may use its own facilities for development, if such a facility is available, subject to approval of the COR or COR designee.

3. Per FDA guidance, comply with the most currently approved operating system and with the most currently approved 3rd party software that JReview uses (e.g. IIS, SAS, and JAVA)

4. Comply with EPLC stage gates and participate in associated reviews

5. For major releases, enhancements, patches, organize software testing, to include unit, system, and user acceptance testing. The Contractor shall modify code to resolve errors found and retest to confirm that code is ready for user acceptance testing.

6. For software patches, the Contractor shall test the patch code at the unit level and the system level including regression testing

6.1. Lead User Acceptance Testing (UAT) to include coordination of testers, and providing test plans, test cases and test scripts for COR and COR designated users to perform UAT. Report test results for each UAT to the COR

7. Maintain change management documentation per FDA CCB Charter (Attachment IDIQ01) and EPLC requirements, to include, as changes and new releases are completed, update of the installation guides for the complete JReview application

8. Maintain and report change management metrics per FDA CCB process

9. Provide Release Notes of COTS changes and fixes to the COR, create draft communications messaging for customers, and provide to COR per release schedule.

10. Implement web page changes, e.g. to reflect informational changes or improvements to registration data collection

Deliverables Table

5-10 per year CCB review of proposed changes

6.3.2. Release Management

1. Develop and deliver a Release Management Plan, in accordance with the EPLC and other FDA release guidance, subject to approval by the COR.

2. FDA will provide Release Management processes and guidance at contract award. Releases under the O&M task are limited to minor (.X) level releases, while major releases (new X.X version) will be managed according to the Integration, Customization and Enhancement section, below. The vendor shall provide a recommended schedule of COTS releases to COR or COR-designee. (Minor enhancements are expected no more than quarterly per year unless unplanned bug fixes are required; major releases should occur no more than once yearly, based on Integrated Clinical Solutions, Inc. release cycle). See ID/IQ section 7.3.2 Release Management for FDA definitions of release categories:

For the purposes of this TO, the following definitions from the IDIQ are provided:

2.1. A major release or major enhancement is defined as a piece of software which is not merely a revision or a bug fix release but which contains substantial changes (e.g., an overhaul of the interface, change in compatibility).

2.2. A “minor update, release, or enhancement” should only consist of bug fixes or improvements in the software (performance, etc.),

2.3. The major number is increased when there are significant jumps in functionality such as changing the framework which could cause incompatibility with interfacing systems, the minor number is incremented when only minor features or significant fixes have been added, and the revision number is incremented when minor bugs are fixed.

3. Conduct regression testing of all releases (i.e. ensure that all JReview capabilities are intact) at the FDA’s test environment

4. Review and update the JReview documentation, such as SOPs; including User Guide, help documentation and FAQs. The Contractor shall present details of the release to the COR and other stakeholders.

5. Maintain and report version release metrics per the Release Management Plan.

6. Validate the current Information System Contingency Plan (ISCP) for impact of releases to system recovery. Update ISCP if changes are required. The current ISCP will be provided at contract award.

Deliverables Table

6.3.3. Other O&M Responsibilities

The Contractor shall maintain and report in the O&M Activities Report the following JReview usage metrics:

1. Number of unique users, defined as non-duplicative logins over a given time period.

2. Number of logins, how often accessed

3. Functionalities accessed

4. Number of studies

Deliverables Table

6.4. Training (Firm Fixed Price)

Training is an integral part of the JReview program. The OCS supports JReview training for FDA personnel. The Contractor shall use the existing JReview training materials (to be provided by the COR at contract award) as guides to draft, develop and modify new training materials. The COR or COR designee will provide the schedule for training delivery upon contract award.

1. Develop and deliver a JReview Implementation of Training Plan for COR or COR designee approval. The plan shall be delivered to the COR within 45 days after Task Order award. The plan shall include a gap analysis of the current training, needs for updated training, a timeline for changes to be completed, and implementation needs. This implementation plan of training will document all changes required to align training with minor and major version changes of the JReview software.

2. The Contractor shall provide to the COR or COR designee a draft of all the materials associated with the course instruction for the training sessions 60 days prior to the start of the training.

3. Conduct up to 24 effective classroom training sessions to keep FDA personnel current on JReview and its use for regulatory review. Historically the classes are approximately 2.5 hours in duration. Classroom training shall include current curriculum of five (5) modules. Refer to modules described below.

4. Conduct up to 6 non-classroom training sessions to include webinar version of classroom instruction and demonstrations.

5. Provide qualified instructors and deliver all classes including learning objectives, course content and delivery of evaluations (delivery of evaluations is to be done at the end of each class). The maximum number of attendees per class will be 15. The Contractor shall provide a second qualified instructor when the number of registered participants is greater than five (5). The second instructor shall provide individual attention and answer questions to classroom attendees during classroom lecture. (Classes may be video recorded by COR or COR designee, with or without students present).

6. Conduct 12 JReview training clinics for reviewers. Clinics shall provide direct in person help with using JReview for a reviewer with individual BLA/NDA submission data. The training clinics will be for a maximum of 4 reviewers per instructor per clinic.

7. Document all attendee questions asked during each class and clinic in the Questions Log specified by the COR or COR designee. The Contractor shall add these questions to the log within three (3) days after each class or clinic. The location of the log will be provided at contract award. The COR and COR designee have access to the Training Questions Log and will review all updates.

8. Update Questions log file with the solution for each question in the log and provide to COR or COR designee.

9. Review and recommend revisions/refinements to current training materials, resources, and delivery methods based on enhancements to application, releases, new standards analyses, and feedback based on user evaluations and FAQs. The requirements for revised class training materials and user guides will be determined by COR or COR designee.

10. Follow FDA versioning guidelines and documentation guidelines as directed by the COR or COR designee when updating class training materials and user guides.

11. Review and provide recommended updates to the Implementation of Training Plan and materials no-less than every six (6) months to reflect the current state of JReview. The Contractor shall present details of the changes to the FDA through Knowledge Exchange. The Contractor shall update the Training Plan with the approved changes and ensure compliance with the COR or COR designee Training Strategy.

Current JReview training classes

Module 1 Introduction to JReview

Module 2 Using Graphical Patient Profiles with JReview

Module 3 Using Cross Tabs with JReview

Two-hour class provides instruction on using the Crosstab function in JReview. Crosstabs are a form of a table. They can be used to create incidence tables for any type of data. A common use for Crosstabs is for reviewing AE incidence tables.

Module 4 Using Graphs with JReview

Two-hour class providing instruction on creating multiple types of graphs in JReview. These graphs can be placed right into a review.

Module 5 Using the Standard Analysis Catalog

Two-hour class provides instruction on how to use the JReview Standard Analysis Catalog for a review. The catalog consists of a series of common, automated analyses for the JReview tool, which is organized according to sections in the CDER Clinical Review Template. The analyses were developed by the CSC with input from reviewers.

6.4.1. Training Sessions

The Contractor’s training staff shall:

1. For a given course, meet and/or electronically communicate with the COR designee prior to and upon completion of courses to discuss arrival times and any other essential course administrative information which may include pre-course meetings, after-hour discussion of course activity or post course evaluations, specific course recommendations, materials, equipment and facilities, as appropriate.

2. Ensure that all GFE audiovisual equipment is in proper working condition and instructional materials/aids are available at least one hour before a given training session begins. Report classroom property and equipment issues to FDA staff promptly.

3. Return all reusable course materials, and report equipment damage, loss or inoperability to the COR designee;

4. Treat students fairly, equitably, and with respect at all times;

5. Provide a training environment that does not permit hostile incidents;

6. Be familiar and in compliance with the FDA policies and instructions that deal with: equal opportunity in Federal education and training programs, civil rights, equal opportunity and affirmative employment, accessible electronic and information technology, equal opportunity for persons with disabilities, sexual harassment, and harassment and retaliation, internet security, and physical security;

7. Maintain a current knowledge of and abide by FDA Emergency Plans including those for medical and fire incidents;

8. Review and conduct a dry-run of exercises prior to class delivery as required.

9. Dress and act in a professional manner. This is characterized by or conforming to the technical or ethical standards of a profession exhibiting a courteous, conscientious and generally businesslike manner in the workplace, as well as the skill, good judgment, and polite behavior that is expected from a person who is trained to do a job well. A professional employee arrives on time for work and manages time effectively. Professional workers take responsibility for their own behavior and work effectively with others. High quality work standards, honesty, and integrity are also part of the package. Professional employees look clean and neat and dress appropriately for the job. Communicating effectively and appropriately for the workplace is also an essential part of professionalism.

Deliverables Table

6.5. User Support (Firm Fixed Price)

On receipt of a Help Desk ticket, the Contractor shall provide the needed technical and application assistance to the user. The Contractor shall evaluate the users’ data and asses the necessary technical and application assistance implications of the JReview analyses as they relate to the submission. The Contractor shall provide onsite expertise at FDA WO during the normal business hours (as defined in the JReview IDIQ). The Contractor shall work with OCS SMEs in the resolution of user/reviewer tickets to determine the root cause(s) of complex problems. The Contractor shall update the Help Desk ticket with issues found, the hours expended and the resolution. The Contractor shall incorporate the resolutions in the SOPs as appropriate. The Contractor shall perform the following activities:

1. Trouble-shoot, review, analyze and provide recommendations to the User in the customization and implementation of JReview Graphical Patient Profiles (GPPs) and templates

2. Review, analyze, and provide recommendations for pooling studies to the User

3. Provide technical advice for FDA’s JumpStart services, JumpStart is an OCS Service that introduces the reviewers to JReview. This will be one of several entry points for reviewers to use JReview. JumpStart will service at least 45 submissions during this Task Order:

3.1. Provide technical advice for customization of GPPs and implementation of analyses from the JReview Standard Analysis Catalog for use in the JumpStart Sessions as requested by the JumpStart team

3.2. Follow-on technical advice to the reviewers after their JumpStart sessions as needed. This type of support is consistent with the above example tasks.

3.3. Attend JumpStart meetings as assigned.

4. Trouble-shoot with the FDA eData team to resolve issues with loading data and data quality.

5. Provide technical advice for JReview analysis and customization of GPPs and implementation of analyses from the JReview Standard Analysis Catalog.

6. Create derivations (new items, new ranges, import SQL) to support the user.

7. Provide technical assistance in the creation of standard analyses and follow CCB process for Standard Analyses Catalog implementation

8. Update documentation to support analyses. This documentation shall explain what each analysis is, the circumstances under which the analysis would be used, and include a description of how the analysis is accomplished.

9. Trouble-shoot data conversion requests to import MAED (MedDRA-based Adverse Event Diagnostics) output data into JReview.

10. Trouble-shoot, review, analyze and provide recommendations to the User for MCM (medical counter-measures) studies.

11. Conduct weekly meetings with COR, FDA support staff and subject matter experts (e.g. medical reviewers and statisticians, trainers, or teams that provide support to the reviewer / statistician community) as provided by the COR or COR designee to discuss expert knowledge and solutions to difficult or common questions. Meetings will be held using a variety of methods, in-person, teleconferences, collaborative (WebEx or other FDA-authorized collaboration tool). Results of these meetings shall result in vendor creation and update of the following documentation:

11.1. Frequently Asked Questions (FAQs)

11.2. SOPs

Deliverables Table

6.6. Integration, Customization and Enhancement (Labor Hours)

The Contractor shall implement COR approved, new integration, development, enhancement and customization into JReview and follow the approved Change Management and Release Management processes.

The Contractor shall identify and notify the COR of any necessary changes to the JReview COTS code for consideration and action by the COR.

6.6.1. Integration Development

The connection between JReview and PORTES (SAS Drug Development) and JReview and CTR (Clinical Trial Repository – Oracle) has not been established with either data source in the production environment. Currently, JReview has connectivity to Janus CTR in the FDA TEST environment.

1. The Contractor shall complete the development, in order to provide connectivity between JReview and PORTES and JReview and CTR (Clinical Trial Repository - Oracle), according to the appropriate FDA EPLC and change management processes. Once complete, the Contractor shall maintain the connectivity between JReview and PORTES and JReview and CTR. The Contractor shall prepare and update a Connectivity Status Report, documenting connectivity availability, risks and issues.

2. Additionally, the Contractor shall monitor the integration points and adjust them as data sources are enhanced. The Contractor shall also provide and maintain web pages to make the access and use of the application (regardless of integration) easier for the end-users. The Contractor shall integrate with API (Application Program Interface) to move access and transfer data automatically to provide users the capability to pull data from these repositories in JReview, and send from these repositories to JReview

3. The Contractor shall complete interfacing software changes on JReview and maintain connectivity between JReview and PORTES (SAS Drug Development), and JReview and CTR (Clinical Trial Repository - Oracle database). For more detailed requirements for these connections, see PORTES / JReview Integration Business Requirements (Attachment TSKORD04), and PORTES / JReview Integration System Requirements (Attachment TSKORD05). Contractor shall validate existing Business and System requirements with the FDA, and update requirements as directed by COR or COR designee.

4. The Contractor shall use the current connectivity documentation for JANUS CTR from the FDA TEST environment, provided at contract award to create the documentation and complete the steps needed to complete the connection in Production.

5. The Contractor shall evaluate the original set of business and system requirements documentation for the integration of PORTES with JReview. (Reference Attachments 4 and 5.) The Contractor shall update the business and system requirements documentation to include any code modifications, release management, and other EPLC requirements to implement PORTES integration into all three environments (TEST, TRAINING, and PRODUCTION for COR approval. Upon COR approval the Contractor shall perform the work necessary to fulfill the requirements. Work shall include any code modifications, release management, and other EPLC requirements to implement PORTES integration into all three environments (TEST, TRAINING, and PRODUCTION).

6.6.2. Minor Enhancements

Each minor enhancement is expected to require 100 hours or less, which includes time for design, development, configuration, test, and deployment. The Contractor shall follow and utilize all applicable EPLC processes and templates for minor enhancement activities. The following is a list of minor enhancements:

1. The Contractor shall maintain and develop standard analyses for customers to use with their standard data. The FDA will monitor updates to the Study Data Tabulation Model (SDTM) standards and the CCB will determine additions to the Standard analysis catalog. Once approved, the Contractor shall implement the changes to the catalog.

2. The Contractor shall use JReview to create and register new analyses and analysis panels associated with new therapeutic area standards, received from Clinical Data Interchange Standards Consortium (CDISC) and FDA. The FDA will follow the CDISC website to monitor approved therapeutic areas, the COR will direct the Contractor to create and register JReview analyses of the therapeutic area.

3. The Contractor shall update the Standard Analysis Catalog as provided by the COR. Prioritized and approved therapeutic areas are determined by CFAST (Coalition for Accelerating Standards and Therapies) and are posted on the CDISC Clinical Data Interchange Standards Consortium) website (http://www.cdisc.org/therapeutic).

6.6.3. Standard Analyses Panels and Catalogs Library

The Contractor shall develop, create, implement customizations and enhancements and maintain a large catalog of standard analyses for customers to use with their standard data. As SDTM standards are updated, the Standard Analysis Catalog shall be updated and maintained. The analyses shall be documented within the catalog; tested (in accordance with the testing requirements described in the Change Management task area) and vetted with various FDA stakeholders prior to being implemented or placed in the production environment and shall be discussed at monthly Knowledge Exchange Meetings. Currently there are approximately 24 analyses within the catalog. The FDA anticipates between six and ten additional analyses created each year.

The Contractor shall also anticipate the addition of therapeutic area standards within SDTM, and therefore, the requirement of additional standard analysis panels shall be anticipated.

Deliverables Table

6.7. Metrics Reporting (Firm Fixed Price)

The Contractor shall collect JReview performance metrics and provide the JReview Project Manager a report with metrics details in order to track JReview project performance. The Contractor shall work with the FDA to finalize the list of required metrics.