A07_SOLICITATION_(W81XWH-16-R-0033).docx

W81XWH-16-R-0033

Section B - Supplies or Services and Prices

LITES - BASE PERIOD

CPFF

Linking Investigations in Trauma and Emergency Services (LITES) - The ceiling amount for LITES orders (less travel) will be reflected on this CLIN. This CLIN amount will be a systematic placeholder used to issue LITES task orders, less travel. However, actual funding will only be applied at the task order level.

FOB: Destination

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

TRAVEL - BASE PERIOD

COST

TRAVEL - The ceiling amount for travel related to LITES will be reflected on this CLIN. This CLIN amount will be a systematic placeholder used to issue travel on LITES task orders. However, actual funding will only be applied at the task order level.

ESTIMATED COST

CPFF

Linking Investigations in Trauma and Emergency Services (LITES) - The ceiling amount for LITES orders (less travel) will be reflected on this CLIN. This CLIN amount will be a systematic placeholder used to issue LITES task orders, less travel. However, actual funding will only be applied at the task order level.

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

COST

TRAVEL - The ceiling amount for travel related to LITES will be reflected on this CLIN. This CLIN amount will be a systematic placeholder used to issue travel on LITES task orders. However, actual funding will only be applied at the task order level.

ESTIMATED COST

CPFF

Linking Investigations in Trauma and Emergency Services (LITES) - The ceiling amount for LITES orders (less travel) will be reflected on this CLIN. This CLIN amount will be a systematic placeholder used to issue LITES task orders, less travel. However, actual funding will only be applied at the task order level.

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

COST

TRAVEL - The ceiling amount for travel related to LITES will be reflected on this CLIN. This CLIN amount will be a systematic placeholder used to issue travel on LITES task orders. However, actual funding will only be applied at the task order level.

ESTIMATED COST

CPFF

Linking Investigations in Trauma and Emergency Services (LITES) - The ceiling amount for LITES orders (less travel) will be reflected on this CLIN. This CLIN amount will be a systematic placeholder used to issue LITES task orders, less travel. However, actual funding will only be applied at the task order level.

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

COST

TRAVEL - The ceiling amount for travel related to LITES will be reflected on this CLIN. This CLIN amount will be a systematic placeholder used to issue travel on LITES task orders. However, actual funding will only be applied at the task order level.

ESTIMATED COST

CPFF

Linking Investigations in Trauma and Emergency Services (LITES) - The ceiling amount for LITES orders (less travel) will be reflected on this CLIN. This CLIN amount will be a systematic placeholder used to issue LITES task orders, less travel. However, actual funding will only be applied at the task order level.

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

COST

TRAVEL - The ceiling amount for travel related to LITES will be reflected on this CLIN. This CLIN amount will be a systematic placeholder used to issue travel on LITES task orders. However, actual funding will only be applied at the task order level.

ESTIMATED COST

CPFF

Linking Investigations in Trauma and Emergency Services (LITES) - The ceiling amount for LITES orders (less travel) will be reflected on this CLIN. This CLIN amount will be a systematic placeholder used to issue LITES task orders, less travel. However, actual funding will only be applied at the task order level.

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

COST

TRAVEL - The ceiling amount for travel related to LITES will be reflected on this CLIN. This CLIN amount will be a systematic placeholder used to issue travel on LITES task orders. However, actual funding will only be applied at the task order level.

ESTIMATED COST

CONTRACT STRUCTURE

All services to be ordered under this contract shall be set forth in individual task orders. The base contract is not funded. Funds will be obligated on task orders written against this contract. Some task orders under this contract may be incrementally funded pursuant to the Limitation of Funds clause, FAR 52.232-22. If the order is incrementally funded, the FAR clause shall be included in each order as applicable and an incremental funding schedule will be provided.

MINIMUM AND MAXIMUM

The minimum guarantee is $100,000.00 over the life of the contract. The anticipated maximum ceiling amount for the base contract is $90,000,000.00 inclusive of the base and any option periods exercised. The Government is not obligated to issue orders up to the maximum amount under this contract. The maximum value for individual task orders will be capped at $25,000,000.00.

PROFIT/FIXED FEE

If a profit/fee is proposed, the maximum fixed fee is capped at 8%. The profit/fee will be paid in accordance with the Government approved term, which will be applied at the task order level.

TASK ORDER LABOR RATES

No task order will be awarded with labor rates higher than those approved in the base contract. Rates approved in the base contract are the maximum labor rates the Government will allow on task orders. These rates may not be re-negotiated

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

LINKING INVESTIGATIONS IN TRAUMA AND EMERGENCY SERVICES (LITES)

INDEFINITE DELIVERY INDEFINITE QUANITITY (IDIQ) CONTRACT IN SUPPORT OF

THE DEPARTMENT OF DEFENSE, JOINT PROGRAM COMMITTEE

ON COMBAT CASUALTY CARE RESEARCH

1.0 Scope: The Department of Defense, Joint Program Committee-6, Combat Casualty Care, has a requirement to establish a clinical research network for the study of clinically-relevant questions in the trauma patient. This clinical program shall be conducted in accordance with applicable Department of Defense (DOD) and US Food and Drug Administration (FDA) regulations and guidelines, to include FDA-required Good Clinical Practices (GCP) and International Conference on Harmonization (ICH-E6) guidelines. The Government is seeking to obtain support of multi-center prospective, injury care and outcomes research of relevance to the DOD. This award is for the performance of non- personal services.

2.0 Background: The DoD Combat Casualty Care Research Program (CCCRP) plans, programs, budgets and oversees the execution of trauma research aimed at optimizing survival and recovery of US service personnel injured (current and future scenarios) in combat. The CCCRP supports research across the spectrum of trauma care, to include point of injury, en-route, and facility-based, with a mission to deliver knowledge and materiel solutions to advance military trauma care. Unlike investigator initiated medical research, the DoD CCCRP supports requirements-driven investigation aimed at resolving defined gaps in combat casualty care.

These gaps or requirements are defined by a number of DoD activities including issuance of Guidance for the Development of the Force (GDF), Capability-Based Assessment (CBA) and the Combat Developer community. Additionally, gaps or requirements in combat casualty care are defined by the military clinical community and several clinical Defense Centers of Excellence (DCoE) (e.g. Joint Trauma System, Defense Center of Excellence for Traumatic Brain Injury and Psychological Health and the National Intrepid Center of Excellence). It is the task of the DoD CCCRP to respond to these gaps and clinical questions through planning, programming and budgeting of relevant medical research and development.

As knowledge and materiel solutions resulting from the basic and preclinical research efforts of the CCCRP develop, they require evaluation and study in the clinical setting. Clinical use studies provide information to hone their relevance and effectiveness and introduce them to the broader clinical practice. In addition, pressing questions from the bedside of combat casualty care and the DCoE rely on clinical research efforts to provide answers and practice-changing knowledge or evidence. In this context the CCCRP requires, as part of its research effort, the capacity to accomplish clinical research in severely injured patients.

3.0 Objective: The purpose of this requirement is to establish a contractual mechanism for the Linking Investigations in Trauma and Emergency Services (LITES) network to conduct Government directed research. The LITES shall create a research network of US trauma systems and centers with the capability to conduct prospective, multicenter, injury care and outcomes research of relevance to the Department of Defense (DOD). With limited ability to conduct larger scale, high-impact, clinical research on US service personnel in active theaters of war, the DoD and its CCCRP must turn to civilian trauma systems and centers to answer questions aimed at narrowing high-priority gaps in care of the severely injured. The imperative to continue to resolve high-priority gaps and provide solutions (knowledge and materiel) to the DoD requirements-driven CCCRP is integral to learning lessons from the recent wars and readying and innovating for future, more complex operational environments.

The LITES network shall be responsive, flexible and efficient, as well as capable of being leveraged by the DOD and its CCCRP to rapidly implement clinical studies that yield operationally oriented, clinically relevant, and timely knowledge in trauma care. The LITES network shall also serve as a platform in which the initial feasibility and effectiveness of materiel solutions emerging from the CCCRP can be studied in a realistic, clinical environment prior to their evaluation in more advanced clinical trials or their broader implementation in the operational environment. The LITES network is not intended to develop investigational products through FDA Licensure. The LITES network shall be a platform in which comparative effectiveness studies can be performed on materiel products, to assess the feasibility and effectiveness of such products in limited and controlled populations prior to their wider study or operational use. The LITES network may also conduct observational and epidemiological studies to address important issues. The information resulting from the LITES network shall be integral to informing new and emerging clinical practice guidelines (CPGs) and clinical recommendations (CR), as well as, modifying or updating existing standards.

This Request for Proposals (RFP) will select an organization to establish the LITES network and conduct the clinical studies, as established by DoD, to provide knowledge products and material solutions. This type of clinical research capability is necessary to allow the CCCRP to address existing and next generation questions and gaps identified from its clinical communities and requirements-generating activities. Securing such a capability is advantageous as a strategic partnership with civilian medicine and is particularly relevant, as combat casualty care and research opportunities from large-scale military operations in Iraq and Afghanistan have ended. The research shall include, but will not be limited to, the conduct of studies in the following settings: pre-hospital (point-of-injury and transport, to include Exception from Informed Consent for Emergency Research (EFIC) per FDA 21 CFR 50.24), emergency department/trauma bay, operating room, post-anesthesia recovery unit, and inpatient care (to include Intensive Care Unit-(ICU care). Specific injury patterns, patient populations, endpoints and consent requirements will vary based on the individual clinical study. The specifics of each study will be defined at the task order level.

The IDIQ contract is for government-directed studies. The contractor does not have any right of first refusal for government-directed studies outside those placed, in the discretion of the government, on task orders up to the established guaranteed minimum established under this contract. In particular, this IDIQ contract is not for studies intended primarily to support FDA licensure of an investigational product. Government monitoring and site visit teams shall be allowed and/or expected as directed by the COR, but will not have primary responsibility for clinical monitoring of the IDIQ studies. The USG shall have access to any enrolling site as well as the coordinating center/lead center, and shall be able to communicate with any site. At the discretion of the USG, military sites shall be included as enrolling centers for any LITES study. The USG shall have input into the selection of enrolling centers for any given LITES study. The USG shall have input and final approval authority for protocols and all clinical study procedures for any LITES study. All enrolling centers shall comply with the government-approved protocol and procedures for any LITES study. Contractor shall ensure that all enrolling centers comply with the USG approved protocol and clinical monitoring plan for each specific LITES task order (study).

4.0 General Information:

4.0.1: Period of Performance. The period of performance for the base “ordering” period is 5-years from date of contract award. In addition, five (12-month) optional ordering periods will be included, that may provide for the continuation of support (through issuance of task orders) for up to 60-months. Note, the period of performance for task order requirements will be specified at the task order level.

4.0.2: Place of Performance. The government anticipates performance of this contract to be in multiple high volume trauma centers, and may include pre-hospital care at the point of injury and transport setting(s) as specified by each task order. The contractor shall be responsible for the safety and security of its employees in all locations. Performance under this mechanism may be required at additional clinical locations, as specified at the task order level.

4.0.3: Contracting Officer’s Representative (COR). The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions:

· Assure that the Contractor performs the technical requirements of the contract;

· Perform necessary Government led monitoring and site visit inspections for management and regulatory compliance in accordance with PWS and the USAMRMC, Army, and DoD human research protection regulatory requirements.

· Maintain written and oral communications with the Contractor concerning technical aspects of the contract;

· Issue written interpretations of technical requirements, including Government drawings, designs, specifications;

· Coordinate availability of government furnished property.

· Provide coordination for government access to all enrolling sites as well as the coordinating centers.

· Coordinate with the Office of Research Protections to monitor, secure corrective actions, and provide guidance on all adverse events, protocol deviations, enrollment of prisoners, deaths etc.

· Recommend the inclusion of military sites as enrolling centers for any LITES study.

· Serve as the government representative to provide input and final approval authority for the selection of enrolling centers, approval of protocols and study procedures for all LITES studies.

The COR is not authorized to change any of the terms and conditions of the resulting order. The COR is designated by the Contracting Officer.

4.0.4: Operations During Emergency Situations. Contingency operation plans shall be developed and provided for each task order. Individual contingency operation plans shall be activated immediately after determining that an emergency has occurred, shall be operational within twelve (12) hours of activation, and shall be sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated. In case of a life threatening emergency, the COR will immediately make contact with the Contractor Task Managers to ascertain the status of any Contractor personnel who were located in Government controlled space, such as a military medical treatment facility, affected by the emergency. When any disruption of normal, daily operations occur, the Contractor Task Manager shall promptly open an effective means of communication with the COR and verify:

· Key points of contact (Government and Contractor)

· Temporary work locations (alternate office spaces, telework, virtual offices, etc.)

· Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier, etc.)

· Essential work products expected to continue production by priority

The Contractor Task Manager, in coordination with the COR, shall make use of the resources and tools available to continue contracted functions to the maximum extent possible under emergency circumstances. The Contractor shall obtain approval from the Contracting Officer prior to incurring costs over and above those allowed for under the terms of this contract. Regardless of contract type, and of work location, Contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately in accordance with the terms of this contract.

4.0.5: Organizational Conflict of Interest. The FAR Part 9.5 provides guidance for Contracting Activities with regards to Organizational conflict of Interest (OCI). OCI is characterized by a) biased judgment on the part of the contractor or b) unfair competitive advantage in procurement. The FAR encourages mitigation of a conflict if at all possible. The Contracting Officer has significant discretion as to the acceptability of any mitigation plan offered. The work to be performed under this requirement has a significant potential for OCI.

Offerors are encouraged to present their best strategy for mitigation of any potential OCI under this requirement. Offerors shall submit a mitigation plan at the task order level and update it as often as necessary throughout the life of the task order.

At the task order level the contractor shall perform a comparative analysis of the potential new work against all current and previous work performed in support of U.S. Army Medical Research Material Command (USAMRMC) in any category other than that of the new work being offered. The comparative analysis must be included in the proposal for each task order, and must include a statement certifying whether the Contractor believes that its performance of the proposed task order would create a real or apparent OCI. For each individual task order issued under this contract, the Contractor shall sign and submit the USAMRMC Organizational Conflict of Interest certification statement (Attachment 2). Failure to adhere to this statement may constitute default on the part of the Contractor.

The Contractor shall also obtain a similar certification of OCI status from all subcontractors, teaming partners or consultants prior to taking any such party under this contract. The Contractor shall appropriately modify and include this Paragraph, in all consulting agreements and subcontracts of any tier to preserve the rights of the Government.

For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

5.0 Performance Requirements:

The Contractor shall furnish the necessary personnel, equipment, supplies and support, to complete the performance of the work outlined below at a standard enabling the CCCRP to achieve the cost, schedule, and performance goals of its research and development activities, and to the level of quality necessary to comply with programmatic requirements, DoD and Army regulations, ISO standards, and FDA and EPA regulations (to include both human subject protection and animal care and use regulations); including submissions to federal regulatory agencies as applicable. Note, task order requirements will be defined at the task order level.

5.1 Clinical Study Execution:

5.1.1: Clinical Study Conduct. The primary focus of LITES is to conduct government-initiated clinical research. The research shall include, but is not limited to, the conduct of studies in the following areas:

· pre-hospital (point-of-injury and transport setting, to include Exceptions from Informed Consent-EFIC))

· emergency department/trauma bay

· operating room

· post-anesthesia recovery room

· Inpatient (including the intensive care unit) setting

The studies will require subjects with a multitude of traumatically-sustained injuries. The mix of patients should include, but are not limited to:

· head injury

· extremity trauma/amputation

· patients at significant risk of hemorrhage and coagulopathy.

· poly-trauma

Specific patient populations, endpoint and consent requirements will vary based on the emphasis of each clinical study. This will be defined within each task order.

5.1.2: Perform study and site management activities. Provide clinical site/facilities and/or associated personnel capable of adequately performing clinical studies in accordance with clinical protocols, treatment protocols and U.S. FDA/ICH guidance. Provide medical, scientific, technical and administrative expertise necessary to manage clinical sites and/or activities associated with the conduct of the study. The clinical site/facility provided may be located worldwide and may be civilian or military, but at least one site must be a military treatment facility (MTF). Activities include, but are not limited to:

· Provide adequate space to conduct a clinical study, as well as any insurance required, if established site is not available.

· Provide qualified and experienced site staff, at adequate levels, to support clinical studies in multiple trauma centers as specified in each task order.

· Prepare documented procedures (e.g.: Clinical Monitoring Plans (CMPs), Standard Operating Procedures (SOPs) or Site Specific Procedures (SSPs)) necessary for the conduct of the study.

· Provide medical and administrative expertise to execute, manage, and monitor clinical study protocols.

· Provide mechanisms to ensure that protocol reportable events (e.g., deviations, unanticipated problems involving risk to subjects or others, SAEs, etc.) are reported as required local IRBs, FDA, and the HQ USAMRMC Office of Research Protections as required.

· Implement, manage/coordinate associated Data Safety Management Boards (DSMB) as needed.

· Implement and/or validate computer-related systems (i.e. data management systems) and equipment necessary for conduct of the clinical study.

· Provide updated descriptive information about the total number of trauma admissions, diagnoses, type of trauma, numbers of procedures, and other clinical and administrative data to adequately describe the trauma patient population for each participating network site and protocol (s)(Deliverable 1).

· Provide an annual analysis of factors within trauma care associated with preventable death or morbidity (Deliverable 2).

5.1.3: Clinical Monitoring. Provide Clinical Monitoring of clinical sites in accordance with FDA/ICH/and other applicable regulatory requirements. Monitoring shall include but is not limited to: development of the clinical monitoring plan, site selection and qualification, study initiation, interim monitoring visits, identification and reporting of protocol deviations, study close out, development of monitoring reports, and follow-up to ensure that timely and effective corrective actions have been implemented. Execute site/study close-out activities, including reconciliation of product accountability information, disposition of investigational or study product, and provision of materials for shipping of product, clinical samples, equipment and study-related documents to locations designated in each task orders. Perform or assist in performance of activities necessary for transportation of products, clinical samples, equipment, and records to locations designated through task orders. Provide technical and regulatory expertise to facilitate implementation of corrective actions.

5.1.4: Clinical Study Product Delivery, Accountability and Logistical Support. Provide technical/scientific, administrative, and logistical support to the study by providing all study product(s) to each clinical site. Such study support tasks may include, but are not limited to: ship/manage, store, and coordinate the shipment of study product(s), clinical samples and study-related records in accordance with applicable regulation and laws, both foreign and domestic. Ensure cold chain management and accountability of all investigational products/samples used in relation to the study. Purchase suitable shipping materials in adequate quantities to ensure successful product/record shipment. Create and/or validate, or oversee the validation of, shipping procedures and methods. Conduct assessment visits/audits of product/record storage repositories to ensure proper storage of study materials/records over the course of the study. Produce assessment/audit reports resulting from aforementioned visits. Arrange for and/or provide a Broker(s) for international shipments (import and export), as necessary. The government may also provide additional requirements to ship product(s) and samples to military/government labs as deemed appropriate for additional testing.

5.1.5: Clinical Data Reporting. To leverage data collected as part of this project, any task order with a primary aim addressing traumatic brain injury, data will be submitted to the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System. Further information about FITBIR and the common data elements can be found at https://fitbir.nih.gov/. Additionally, if the DoD central repository for trauma research data, currently called ‘National Trauma Research Repository’ (NTRR), has been created prior to the conclusion of this award, data will be submitted to the repository. It is also expected that each participating site will be submitting clinical data to the National Trauma Data Base (NTDB) using established processes. Additional information about the NTDB can be found at https://www.ntdbdatacenter.com. As much as possible, established common data elements as defined by the FITBIR, NTRR and/or NTDB will be used by all centers to ensure consistency of data (see https://fitbir.nih.gov/jsp/define/index.jsp and http://www.ntdsdictionary.org/index.html for established definitions).

5.2 Clinical Study Development:

5.2.1: Clinical Site Selection and Preparation. Through scientific, clinical, technical and administrative expertise, identify appropriate clinical sites to accomplish the intent of each clinical study. In addition to the established network sites, clinical studies may be conducted in a military medical center or a specific trauma center. The Government may recommend a site, at which time the Contractor would then need to provide the support necessary to include the site. Activities include, but are not limited to:

· Evaluate/assess candidate sites, civilian and/or military.

· Select candidate sites meeting the requirements specified in each task order.

· Provide support to arrange/coordinate travel for non-government members and/or collaborators for the conduct and/or oversight of site assessment and selection visits, civilian and/or military, as defined at the task order level.

· Provide detailed analysis of potential candidate sites in terms of ability to meet the clinical requirements of the study. The detailed analysis shall be presented in the response to requirements defined at task order level. The report shall include, at a minimum, strengths and weaknesses of each site in relation to recruitment requirements, recommended remediation activities, necessary equipment and or infrastructure costs, analysis of staffing and Principal Investigator (PI) qualifications, cost of remediation activities and materials, and a recommendation for selection. The government maintains final approval authority.

· Provide scientific/technical and administrative expertise to remediate clinical site deficiencies to meet the requirements identified in each task order. Activities may include, but are not limited to performing and/or contracting for activities required to train study site personnel in duties/responsibilities related to conduct of the study, activities related to remediation of any technical issues (e.g.: shipment, installation, qualification and maintenance of required equipment, and costs associated with facility/space rental), and if necessary to remediate compliance issues (FDA/ICH/ other applicable federal and DoD regulations).

· Provide system to ensure that Institutional Review Board approval and DoD-required Human Research Protection Official (HRPO) approval are obtained for each protocol by site before study initiation.

· Provide system to ensure continued compliance with FDA, federal and DoD human research protection regulatory requirements

5.2.2: Clinical Supplies and Equipment Procurement. Obtain supplies and equipment essential to the conduct of the clinical studies outlined in each individual task order in a cost effective and timely manner.

5.2.3: Clinical Planning. Develop the clinical monitoring plan to maintain oversight and staffing levels of clinical study sites for the performance of all levels of clinical study protocols. Such sites may be academic, civilian, or military sites.

5.2.4: Clinical Recruitment. Plan for the activities required to recruit study volunteers in accordance with each task order. Work in this task includes, but is not limited to: developing recruitment strategy(ies), community consultation and public disclosure programs for EFIC studies, developing informed consent (IC) and legally authorized representative permission forms, and developing marketing materials (e.g.: advertisements, fliers, commercials, etc) as needed to achieve the recruitment goals of the study. All recruitment material must be approved by the local IRB and the ORP, prior to executing.

5.2.5: Clinical Protocol Development. Develop the clinical study protocols and related documents, to meet the specifications outlined in each task order by providing the scientific, clinical and administrative expertise necessary. Related documents include, but are not limited to: Case Report Forms (CRFs) and Informed Consent Forms. These documents must be developed in accordance with institutional, IRB, and federal requirements detailed in the task order. The contractor shall be responsible for all of the electronic master files, to include, translation services (as necessary) for study documents. These documents must be available for review at the discretion of the government.

5.2.6: Institutional Review Board Review Coordination. The JPC-6 prefers that the LITES network identify a single Institutional Review Board (IRB) and process to review and approve research protocols that involve multiple network institutions to reduce IRB burdens and delays in the conduct of the LITES network's multicenter studies. A single IRB will conduct reviews on behalf of all study sites that agree to participate in the network. When conducting multi-site EFIC trials, the local institution’s IRB may elect to participate in the local community consultation process. The institution providing the single IRB must provide a letter of intent to the USAMRMC indicating the institution’s willingness and capability to serve as the single IRB for the network. Each network member institution must provide an institutional letter of intent indicating the institution’s agreement to rely on a single IRB for multisite studies. For each study conducted by the network, the Institutional Official of each network institution participating in the multi-site study is required to provide a Letter of Intent that consents and agrees, wholly with the review of the central IRB for that study.

5.2.7: Clinical Data Management. Plan for and provide full clinical data management as required by the task order, using electronic systems that are compliant with FDA/ICH/HIPAA and other applicable federal regulations.). Use of paper systems will be limited and only accepted on a case by case basis, such as a site location with limited access to electricity. Clinical data management activities include, but are not limited to: protocol review, CRF or electronic Case Report Form (eCRF) creation and modification, CRF or eCRF completion instructions, clinical database development, programming, testing and validation, end user training, data tracking, data entry, data query generation and resolution, medical coding (using MedDRA and WHO-DD dictionaries), database locking or unlocking, data transfer, data reconciliation, and reporting. The Clinical Data Monitoring Plan is subject to the review of the government at its discretion.

5.2.8: Clinical Data Monitoring Committees (also known as Data and Safety Monitoring Boards (DSMBs) or Data and Safety Monitoring Committees (DMCs)) or Data Review Committees (DRC). Establish a clinical DMC or DRC. Responsibilities include, but are not limited to: Drafting a DMC/DRC charter, identifying relevant members to include a physician with appropriate expertise, but not involved with the study, coordinating DMC/DRC meetings, providing meeting minutes, drafting and communicating recommendations to the Sponsor. A core capability to monitor the clinical data must be maintained with the ability to adjust resources as defined by the individual task orders. The government will provide a federal member (military or civilian) to serve on the DSMB.

5.2.9: Safety Pharmacovigilance. Plan for and provide safety pharmacovigilance (PVG) support for safety surveillance, using electronic systems that are compliant with FDA/ICH/EPA regulations (as applicable), and PVG activities associated with the development and marketing of FDA-regulated medical products in accordance with FDA, ICH –E6 and other applicable laws and regulations. Provide medical and technical expertise in these areas to evaluate safety events reported to the regulatory Sponsor and to provide severity and causality assessment, expedited reporting determination, and ongoing safety surveillance of medical products. Communicate with clinical site staff to exchange safety information and provide written evaluation within required reporting timeframes to regulatory Sponsor and the government.

5.2.10: Clinical Statistical Personnel. Plan for and provide Statistical personnel with the expertise to facilitate clinical studies planning, design and data analysis. Statistical support shall include, but is not limited to, advising on protocol design; sample size calculations, development of statistical analysis plans; implementation and/or purchase of statistical analysis software (SAS Institute software unless otherwise specified); performance of statistical analyses; and development of tables, listings and figures illustrating such analyses for inclusion in regulatory submissions and final clinical study reports. A core capability of statistical personnel must be maintained with the ability to adjust staffing as defined by the individual task orders

5.2.11: Clinical Training. Provide training support required for the conduct of the clinical study. Activities may include, but are not limited to, selection of qualified training providers, development and/or distribution of training materials, provision of on-site training audio/visual equipment, providing a means for off-site training attendees to participate in training opportunities, and support for non-government study-related personnel for travel and expenses necessary to attend training sessions.

5.3 Regulatory Support:

5.3.1: Regulatory Document Support. Provide scientific/technical, financial, regulatory, and administrative support for the development, review, and submission of clinical study regulatory documents. Regulatory documents will be prepared for timely submission to the Institutional Review Board, the HQ USAMRMC Office of Research Protections (ORP) Human Research Protection Office (HRPO) located at Fort Detrick, other review boards, and other relevant organizations, as required. Examples of regulatory documents include, but are not limited to:

· Clinical Synopsis, Protocols and Reports

· Subject Materials (e.g. recruitment materials, informed consent forms, community consultation plans)

· Institutional Review Board Application

· Institutional and regulatory committee approval letters

· Case Report Forms

· Source documents

· Medical Product Package Insert/Investigational Brochure

· Validation packages for assays, software, or medical devices

· Annual Reports, Safety Reports, Protocol/Information Amendments

· Correspondence with government regulatory agencies

Protocol deviations, enrollment of prisoners, serious adverse events (SAEs), Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO), clinical holds (voluntary or involuntary), deaths, and suspension or termination of this research by the IRB, the institution, the Sponsor, or regulatory agencies, shall be promptly reported to the USAMRMC ORP and the USAMRAA Contracting Office.

Documents must be formatted in accordance with applicable FDA and USAMRMC requirements as specified within the individual task order.

5.3.2: Document Management Support. Provide support for management of documents and items for historical and ongoing product development efforts. This may include support for data base management of the documents and supporting items as well as “hands-on” cataloging and sorting of items for appropriate disposition.

5.3.3: Regulatory Meeting Support. Provide scientific, technical, regulatory, and administrative support for the conduct of regulatory meetings to include preparation of read-ahead packages and meeting minutes.

5.4 Translation of Documents:

Provide translation of Human Use/Consent study documents from English to other languages for non-English speaking subjects. Translation will be based on site selection and task order requirements. The contractor shall be prepared to provide translation services, in the language(s) and timelines specified in individual task orders, to facilitate communications.

5.5 Contract Management:

5.5.1: Contract Management. The contractor shall provide a contract manager (program administrator) who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 am and 4:00 pm, Monday through Friday except Federal holidays or when the government facility is closed for administrative reasons.

For each task/delivery order issued under this contract, the Contractor shall sign and submit the Non-Disclosure Statement (Attachment 3) on behalf of the company, and shall also ensure that all staff assigned to, including all subcontractors and consultants, performing on each task order execute and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other contractors. Assignment of staff who has not executed this statement or failure to adhere to this statement may constitute default on the part of the Contractor.

The Government will use electronic tools to manage awards resulting from this contract. Those tools include but are not limited to Electronic Grants System (EGS), Electronic Data Management System (EDMS), Electronic Data Capture (EDC), and Clinical Trial Management System (CTMS).

5.5.2: Labor Mix Review. The contractor shall review its base contract labor mix on an annual basis and provide the Contracting Officer any recommended additions or deletions 30 days prior to the contract anniversary date during the base period and 30 days prior to the beginning of each option period (Deliverable 3).

5.5.3: Monthly Task Status Report. The contractor shall submit a Monthly Task Status Report (Deliverable 4). The contractor shall submit the report with a transmittal letter not to exceed one page that highlights major events in the reporting period. The report will be sorted by the task order number. The report shall include all task orders open within the reporting period. The report shall include details outlining the expenditures and billings to date, projected expenditures and billings, progress, status, and any problems/issues encountered. This report does not replace reporting on Fixed Fee as required by Federal Acquisition Regulation (FAR) 52.216-8. The contractor shall require and incorporate input from subcontractors where there are critical or significant tasks related to the prime contract. Critical or significant tasks shall be defined by mutual agreement between the Government and contractor. The format for the report shall be agreed upon by the Government and contractor. Additional reporting requirements will be identified at the task order level.

5.5.4: Subcontractor Approval. The Government reserves the right to approve the use of all subcontractors and/or site selection prior to award of each task order. In addition, the Government reserves the right to recommend specific support subcontractors to be considered by the prime.

5.5.5: Subcontractor Expenditures. If subcontractors are utilized, the Contractor shall prepare and deliver a Subcontract Expenditures Report that discloses actual subcontract expenditures by company/institution name, business size standard (i.e. Woman Owned Business, Veteran Owned Business, etc.), and other socioeconomic programs (i.e. Indian Incentive Program, Historically Black Colleges and Universities and Minority Institutions, etc.). This shall be completed (as applicable) at the task order level.

Contractors are required to submit their Individual Subcontracting Report (ISR) and subcontracting accomplishments for Federal Government contracts in the Electronic Subcontracting Reporting System (eSRS) at www.esrs.gov.

5.5.6: Meetings. The Contractor shall schedule and conduct a contractual kick-off meeting in coordination with the Government within 30 business days after base contract award. The meeting shall be the initial discussion at which the Contractor shall present to the government an overview of their approach and established schedules, procedures, and points of contact necessary to conduct the required tasks.

The Contractor shall be available for an annual Government review meeting that is specific to this award. The initial meeting shall take place no later than15 months after award of the base contract, and will repeat annually until the last year of the award. If necessary, the Contractor shall also be available for a monthly teleconference that is specific to this award to review the Monthly Task Status Report and provide interim updates.

Infrequently, the Government may require Contractor attendance, including the attendance of Contractor Key Personnel, at meetings in various locations. Meetings may be held via web-casting, teleconference, in-person at a government facility, a commercial conference center, or a mutually agreed-upon Contractor facility on a rotational basis, as determined by the Government.

Additional kick-off and other meeting requirements will be identified at the task order level. For efficiency, the Government may require that meeting requirements specific for this award and at the task order level be combined.

5.6 Security Requirements:

5.6.1 Network Security. Task orders may require background checks or security clearances. Network security requirements will be determined at the task order level.

5.6.2 Antiterrorism (AT) and Operations Security (OPSEC) Compliance. Contractors may be required to complete AT and OPSEC training. Training requirements will be defined at the task order level.

5.7 Travel and Other Direct Costs (ODCs): ODCs shall be billed on a cost reimbursable basis. ODCs are defined as purchase price of materials or services plus applicable indirect costs and tax (if applicable), fee will not be paid on ODCs or travel.

Contractors will be authorized travel expenses consistent with the substantive provisions of the JTR and the limitation of funds specified in this contract. All travel requires Government prior approval/authorization by the COR.

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. Contractor shall submit travel requests with estimated costs to the COR NLT 15 days prior to travel. Travel costs shall be incurred and billed in accordance with Federal Acquisition Regulation Part 31. Costs for these expenses will be reviewed and approved by the COR. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area that results in reasonable charges to the government.

5.8 Key Personnel: Substitutions of proposed Key Personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement Key Personnel shall have qualification equal to or greater than the individuals proposed. For temporary and/or permanent replacement of Key Personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of Key Personnel. Contractor personnel must submit necessary information to be issued a clearance prior to reporting for performance.

The following labor categories are considered Key Personnel for management of the base award:

· Senior Research Scientist (“Principal Investigator”)

· Program Administrator

· Central IRB Coordinator

Other Key Personnel will be identified at the task order level.

5.9 Contractor Employees:

5.9.1: Contractor Identification. The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

5.9.2: Attendance at Meetings. Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this award and/or task orders. Contractor personnel shall make their Contractor status known during introductions.

5.9.3: Use of Military Rank by Contractor Personnel. Contractor personnel, while performing in a Contractor capacity, are prohibited from using their retired or reserve component military rank or title in all written or verbal communications associated with the contract.

5.9.4: Conduct. The Contactor shall not supervise, direct, or control the activities of Government personnel or the employee of any other Contractor under the contract and the Government will not exercise any supervision or control over the Contractor in the performance of contractual services under this contract. The Contractor is accountable to the Government for the actions of its personnel. The Contactor shall ensure that all of its employees, including Subcontractor employees, working under this contract are informed of the substance of this Section. If the Contractor believes any action or communication has been given that would create a personal services relationship between the Government and any Contractor employee or any other potential supervision or duty violation, the Contractor must notify the Contracting Officer immediately of this communication or action.

The Contactor shall not discuss with unauthorized persons any information obtained in the performance of work; conduct business not directly related to this contract on Government premises; use Government computer systems and/or other Government facilities for company or personal business; recruit on Government premises; or otherwise act to disrupt official Government business. The Contactor shall ensure that all of its employees, including Subcontractor employees, working under this contract are informed of the substance of this Section. If the Contractor believes any action or communication has been given that would create a business ethic or conduct violation, the Contractor must notify the Contracting Officer immediately of this communication or action.

5.10 Government Furnished Equipment (GFE) / Information (GFI)/ Property (GFP): The Government may provide various pieces of IT and communications equipment/information/property or require the…