RFP-W81XWH-17-R-0010.docx

W81XWH-17-R-0010

Section B - Supplies or Services and Prices

Job

PTSD-Clinical Trials

CPFF

The contractor is responsible for all resources necessary to perform in accordance with Section C, Statement of Objectives. Period of Performance: Four (4) years FOB: Destination

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

Exhibit 1, Data Item No. A0001

COST

Base Period - Contract Data Requirements List (CDRL), Exhibit 1, Data Item No. A001, Scientific and Technical Reports, Statement of Work (SOW). Section [INSERT SOW REF. BASED ON PROPOSED SOW].

ESTIMATED COST

Other Direct Costs (ODC's)

CPFF

Base Period- Other Direct Costs

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

Travel

COST

Base Period-Travel

ESTIMATED COST

Section C - Descriptions and Specifications

STATEMENT OF OBJECTIVES

DEPARTMENT OF DEFENSE (DoD) JOINT PROGRAM COMMITTEE FOR MILITARY OPERATIONAL MEDICINE (JPC-5), MILITARY OPERATIONAL MEDICINE RESEARCH PROGRAM (MOMRP), PSYCHOLOGICAL HEALTH AND RESILIENCE PROGRAM AREA

UTILIZING DISSEMINATION AND IMPLEMENTATION (D&I) SCIENCE TO OPTIMIZE DISSEMINATION AND IMPLEMENTATION OF SELECT EVIDENCE-BASED PTSD TREATMENTS THROUGHOUT THE MILITARY

1.0 GENERAL

The DoD, JPC-5/MOMRP mission is to develop effective medical countermeasures against operational stressors and to prevent physical and psychological injuries during training and operations in order to maximize the health, performance, readiness, and fitness of Service members (SMs). The JPC-5/MOMRP Psychological Health and Resilience Program area supports both individual and multiagency research efforts aimed at promoting psychological health of SMs and military families through improving prevention, detection, and treatment of psychological health issues.

1.1 BACKGROUND

The focus of this opportunity is to support the DoD, JPC-5/MOMRP mission of maximizing the psychological health and readiness of SMs by applying dissemination and implementation (D&I) science expertise and methods to increase the reach and use of evidence-based practices and tools to improve mental health service quality and delivery in the military. Research documenting deployment and reintegration stressors and mental health issues among SMs and their families has demonstrated the critical need for services and preventive programs designed to reduce the impact of mental health issues on SMs.

In recent years, healthcare policy has incorporated evidence-based practice (EBP) as the central tenet of healthcare delivery. EBP has been defined as the purposeful integration of the best available research evidence, practitioner expertise, and consumer values in making decisions about the care of patients and communities. Similar to EBP, evidence-informed practice calls for practitioners and policymakers to integrate the current, best available scientific evidence in prevention and intervention efforts, while recognizing that clinical decision-making is complex and, therefore, requires flexibility in application of this evidence.

A myriad of barriers constrain mental health treatment accessibility, engagement, and utilization. There are several challenges to ensuring the adoption of EBP that result in a slow pace of dissemination and uptake of empirically supported medical and psychological interventions. The process of implementation presents a series of challenges to provider adoption, fidelity to the specific manualized intervention, and the long-term use and sustainability of the identified approach or intervention. Meta-analysis regarding the typical timeline from bench to full implementation in health research translation has revealed that it takes an average of about 17 years for research evidence to reach clinical practice.

Implementation research is the scientific study of methods to promote the integration of research findings and evidence-based interventions into healthcare practice and policy (https://www.fic.nih.gov/researchtopics/pages/implementationscience.aspx). The effective dissemination and implementation of evidence-based health interventions within military settings are important cornerstones to expanding and accelerating the availability and effectiveness of quality health and mental health services.

1.2 OBJECTIVE

This requirement provides funding for research that will utilize D&I science principles and approaches to optimize dissemination and implementation of evidence-based PTSD treatments within the military. D&I research studies typically involve both interdisciplinary cooperation and transdisciplinary collaboration, utilizing theories, empirical findings, and methods from a variety of fields not traditionally associated with health research. Relevant fields include but are not limited to: information science, clinical decision-making, organizational and management theory, economics, individual and systems-level behavioral change, public health, business and public administration, statistics, anthropology, learning theory, engineering, and marketing. D&I research should include significant and ongoing collaboration with stakeholders from multiple military and civilian mental health and/or clinical practice settings as well as consumers of these services and their families/social networks.

The intent of this requirement is to encourage trans-disciplinary teams of scientists and practice stakeholders to work together to develop systems-level approaches that include models for disseminating and implementing evidence-based interventions and tools within the military that may include interventions that target multiple settings within the military . The intent of this requirement is to support studies that will develop and accurately and transparently assess the outcomes of D&I efforts. The key performance objective is to utilize D&I science to accelerate translation, adoption, and sustainment of end-user focused, evidence-based interventions and tools to encourage adherence to best practice guidelines, reduce variations in clinical practice, and ensure quality standards of care within the military context.

2.0 UTILIZING DISSEMINATION AND IMPLEMENTATION (D&I) SCIENCE TO OPTIMIZE DISSEMINATION AND IMPLEMENTATION OF SELECT EVIDENCE-BASED PTSD TREATMENTS WITHIN THE MILITARY

2.1 TECHNICAL TASKS

2.1.1 The contractor shall provide a plan to utilize and test D&I principles and approaches to optimize D&I of evidence-based PTSD treatment within the military. The Offeror will propose a framework and model for D&I addressing the following technical tasks and then the Offeror will evaluate the effectiveness of the model to improve dissemination and implementation of a specific PTSD treatment intervention that will be designated by the DoD Mental Health Working Group (DoD MHWG) within thirty (30) days of the award. The contractor will work closely with the DoD MHWG point of contact that will be provided within thirty (30) days of the award. The contractor is responsible for performing all scientific, technical, and administrative support tasks that align with the following technical tasks:

2.1.1.1 Develop or adapt an existing framework utilizing D&I science and outcome measurements to optimize DoD D&I of evidence-based PTSD interventions currently under consideration by DoD for broader scale implementation. The specific PTSD intervention (e.g., Exposure Based Therapies, Cognitive Based Therapies, and others consistent with current VA/DoD Clinical Practice Guidelines) will be identified within thirty (30) days of the award by the DoD MHWG. Proposals that focus on identifying best practices for facilitating provider training and adoption, treatment fidelity, adherence, optimization of treatment sessions, standardization of processes, and identification/remediation of technical barriers to treatment are preferred. An acceptable proposal would include but not be limited to the following considerations: symptom amelioration, treatment adherence, fidelity, measurement tools, time to recovery, duration of care, and delivery modality (e.g., individual, group, family). The key performance objectives are to (1) utilize implementation science to develop/adapt a D&I framework and model; (2) apply the model to a DoD identified evidence-based intervention; (3) evaluate the ability of the D&I approach to accelerate translation and adoption of end-user focused, evidence-based interventions, inform best practice guidelines, reduce variations in clinical practice, and setting quality standards for the military.

2.1.2 Collaborations with military treatment facilities, populations and resources are essential and a requisite of this requirement. Offerors should provide details of previous and/or ongoing work within the Military Health System. Within thirty (30) days of the award, selected Offerors will be provided with a technical task-specific Service point-of-contact.

2.1.3 Provide Letters of Organizational Support (recommended two-page limit per letter): Provide a letter (or letters, if applicable), signed by the Department Chair or appropriate organization official, confirming the laboratory space, equipment, and other resources available for the project. Letters of support not requested for this requirement such as those from members of Congress, do not impact proposal review or funding decisions.

2.1.4 Provide Letters of Collaboration (if applicable) (two-page limit per letter): Provide a signed letter from each collaborating individual or organization that will demonstrate that the PI has the support or resources necessary for the proposed work.

2.1.5 Provide Approval for Access to Military Treatment Facilities, Populations. and Resources (one-page limit per site): A letter of support, signed by the lowest-ranking person with approval authority, should be included for studies involving active duty military, military treatment facilities, military-controlled study materials, and databases.

2.1.6 Proposed timeline spanning the lifetime of the research effort, with key milestones and deliverables delineated. Identify critical events and relevant target dates that must be accomplished in order for the project to be successful in terms of cost, schedule and performance.

2.1.7 Contractors shall perform applied and/or clinical research and must have broad utilization across the military lifecycle or be focused on a particular phase. Contractors shall consider feasibility issues associated with the training of providers and treatment fidelity issues. Additional considerations include important military lifecycle stages or transitions as well as proposing a model that is viable to execute within existing military infrastructure and appropriately leverages existing resources. When relevant, limits related to confidentiality concerning research data that involve reporting of illegal behavior by SMs and/or their families need to be carefully considered and addressed within the proposal.

2.1.7.1 Studies designed to test the efficacy of interventions do not meet the intent of this requirement.

2.1.7.2 Studies involving animal research do not meet the intent of this requirement.

2.1.7.3 Studies involving Reserve Component members (unless in activated status) or Veterans do not meet the intent of this requirement.

2.1.7.4 Applied research is defined as work that refines concepts and ideas into potential solutions with a view toward evaluating technical feasibility of approaches, clinical guidance, and/or emerging approaches and technologies. Applied research may involve human subjects to include behavioral healthcare providers.

2.1.7.5 A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. Human subjects referred to within this funding opportunity may include both patients (treatment impact) and providers (implementation feasibility, process, and outcomes).

2.1.8 Explain how the proposed work will utilize D&I science principles and methods to accelerate translation and adoption of interventions to inform best practice guidelines, reduce variations in clinical practice, and set quality standards that are within the military’s legal and operational control. Describe the D&I model in detail such that the model is reproducible and can be independently replicated and validated. Discuss how the proposed study complements ongoing DoD, VA, and other federal agencies’ research if applicable. Explain how the proposed approach utilizes designs that develop a knowledge base about “how” interventions are translated to military practice settings that go beyond distribution of information about the intervention. Describe how the proposed approach and model for disseminating and implementing evidence-based interventions and tools throughout the MHS targets multiple levels of military and civilian personnel within a military environment. Elucidate to what extent the proposed approach addresses the potential immediate or long-term psychological health and well-being of SMs, their families, and/or communities. Describe how and to what extent the proposed approach and model can be potentially applied to the D&I of other interventions or tools.

2.1.9 Provide a description of the hypotheses or objectives, specific aims, experimental design, methods, and analyses for the proposed project. Present the scientific and theoretical rationale behind the proposed work. Cite relevant literature and pilot or preliminary data. Describe previous experience most pertinent to this project.

2.1.10 Describe how the preliminary data and scientific rationale support interdisciplinary cooperation and transdisciplinary collaboration encompassing theories, empirical findings, and methods from a variety of fields not traditionally associated with health research. Align the methods and procedures with the research aims. State how they will be developed and integrated into the project and their feasibility to address the need(s) described. Identify any potential problems and address alternative approaches.

2.1.11 Outline a study data management plan for sharing of research data as appropriate for the type of study proposed. Describe all methods used for data collection to include the following:

2.1.11.1 Identifiers: Describe the unique identifiers or specific code system to be used to identify human subjects, if applicable.

2.1.11.2 Confidentiality: Explain measures taken to protect the privacy of study human subjects and maintain confidentiality of study data. Strategies to protect the privacy and confidentiality of study records, particularly those containing identifying information, should be addressed.

2.1.11.3 Address who will have access to study records, data, and specimens, including an acknowledgment that representatives of United States Army Medical Research and Materiel Command (USAMRMC) are eligible to review study records.

2.1.11.4 Address requirements for reporting sensitive information to state or local authorities.

2.1.11.5 Disposition of data: Describe where data (both electronic and hard copy) will be stored, who will keep the data, how the data will be stored, and the length of time data will be stored.

2.1.11.6 Sharing study results: In cases where the human subject could possibly benefit medically or otherwise from the information, explain whether or not the results of screening and/or study participation will be shared with human subjects or their primary care provider, to include results from any screening or diagnostic tests performed as part of the study.

2.1.12 Describe the data and research resources sharing plan; Describe how data and resources generated during the performance of the project will be shared with the research community. PIs may be required to incorporate Common Data Element measures from the Core and Specialty collections, which are available in the Mental Health Research Collection (Psychiatric, Psychosocial, Alcohol, Tobacco, and other substances as well as Substance Abuse and Addiction) of the PhenX Toolkit (https://www.phenxtoolkit.org/index.php) into all studies involving human subjects as applicable. For projects involving clinical trials, PIs will be required to register clinical trials on Clinicaltrials.gov (https://clinicaltrials.gov/). Additionally, the government reserves the right to identify repositories for submission of data for archive.

2.1.13 Describe the facilities and equipment available for performance of the proposed project and any additional facilities or equipment proposed for acquisition at no cost to the award. Indicate whether or not Government-furnished facilities or equipment are proposed for use. If so, reference should be made to the original or present Government award under which the facilities or equipment items are now accountable.

2.1.14 Describe how the background and expertise of the Principal Investigators(s) PI(s) and other key personnel demonstrate their ability to perform the proposed research or clinical trial and appropriate composition of the research or study team (e.g., study coordinator, statistician). Demonstrate to what extent the PI has formed a transdisciplinary team of scientists and clinical practice stakeholders to work together to develop and/or test conceptual models of dissemination and implementation. Describe the levels of effort by the PI(s) and other key personnel. State whether each key investigator’s record of accomplishment demonstrates his/her understanding of working with military populations. Include any previous work involving military participants or collaborators.

2.1.14.1 Include a list of relevant publication URLs and/or patent abstracts.

2.1.15. Describe the Active Duty military population(s) that will be most relevant to the proposed research project, the appropriateness of the population(s) for the proposed study, and the feasibility of accessing the population.

2.1.15.1 State explicitly how the proposed work will have an impact on implementing an evidence-based intervention throughout the MHS or interventions that target multiple levels within the military.

2.1.16 Prepare for and attend a 2-day Government In-Progress Review (IPR) in the National Capital region annually.

2.1.17 For applied and clinical trial research involving human subjects:

2.1.17.1 Define the study variables and describe how they will be measured. Include a description of appropriate controls and the endpoints to be tested.

2.1.17.2 Describe the target population (to whom the study findings will be generalized) and the nature, approximate number, and pertinent demographic characteristics of the accessible population at the study site (population from whom the sample will be recruited/drawn). Demonstrate that the research team has access to the proposed study population. Furthermore, discuss past efforts in recruiting human subjects from the target population for previous clinical trials (if applicable). Address any potential barriers to accrual and plans for addressing unanticipated delays. Include justification of any age, race, ethnicity, or sex limitations provided.

2.1.17.2.1 Describe access to the subject population(s) with a viable plan for recruitment, consent, screening, and retention of appropriate subjects, and identify sampling methods to gain a representative sample from the population(s) of interest.

2.1.17.2.2 Explain methods for recruitment of human subjects (e.g., medical record review, obtaining sampling lists, and healthcare provider identification).

2.1.17.2.3 Describe the recruitment process in detail. Address who will identify potential human subjects, who will recruit them, and what methods will be used to recruit them.

2.1.17.2.4 Include a detailed description of and justification for the compensation plan if the human subjects will be compensated for participation in the study.

2.1.17.2.5 Describe the recruitment and advertisement materials. The recruitment materials should not be coercive or offer undue inducements and should accurately reflect the study.

2.1.17.3 Describe the human subject-to-group assignment process (e.g., randomization, block randomization, stratified randomization, age-matched controls, alternating group, or other procedures), if applicable. Explain the specific actions to accomplish the group assignment (e.g., computer assignment, use of table of random numbers).

2.1.17.4 Describe the reliability and validity of assessment measures, if applicable. Include critical survey questions, if applicable.

2.1.17.5 List the inclusion and exclusion criteria for the proposed research. Inclusion/exclusion criteria should take into consideration the specific risk profile of the studies to be conducted and the standard of care for that patient population. Provide detailed justification for exclusions.

2.1.17.6 Inclusion of Women and Minorities in Study. Consistent with the Belmont Report, “Ethical Principles and Guidelines for the Protection of Human Subjects,” and Congressional legislation, special attention is given to inclusion of women and/or minorities in studies funded or supported by the USAMRMC. This policy is intended to promote equity both in assuming the burdens and in receiving the benefits of human subjects research. Include an appropriate justification if women and/or minorities will be excluded from the clinical research/trial

2.1.18 Specifically describe the plan for obtaining informed consent from human subjects.

2.1.18.1 For the proposed study, provide a draft, in English, of the Informed Consent Form.

2.1.18.2 Identify who is responsible for explaining the study, answering questions, and obtaining informed consent.

2.1.18.3 Include a plan for ensuring that human subjects’ questions will be addressed during the consent process and throughout the trial.

2.1.18.4 Address how privacy and time for decision-making will be provided and whether or not the potential human subject will be allowed to discuss the study with anyone before making a decision.

2.1.19 List and describe any evaluations (e.g., laboratory procedures, history, or physical examination) that are required to determine eligibility/suitability for study participation and the diagnostic criteria for entry. Note that some screening procedures may require a separate consent or a two-stage consent process. Informed consent must be obtained prior to initiation of any procedures for the purpose of determining eligibility.

2.1.20 Clearly identify all study risks. Study risks include any risks that the human subject is subjected to as a result of participation in the clinical study or trial. Consider psychological, legal, social, and economic risks as well as physical risks. If the risks are unknown, this should be stated. If applicable, any potential risk to the study personnel should be identified.

2.1.21.1 Describe all safety measures to minimize and/or eliminate risks to human subjects and study personnel or to manage unpreventable risks.

2.1.21.2 Discuss the overall plan for provision of emergency care or treatment for an adverse event for study-related injuries, to include who will be responsible for the cost of such care.

2.1.21.3 Address any special precautions to be taken by the human subjects before, during, and after the study.

2.1.21.4 Describe any special care or equipment (e.g., monitors, telemedicine equipment) needed for human subjects enrolled in the study.

2.1.21.5 Describe known and potential benefits of the study to the human subject, a specific community, or society.

2.1.22 Perform all clinical trial monitoring responsibilities to include but limited to the following:

2.1.22.1 Develop and submit a recruitment and retention plan for each clinical site

2.1.22.2 Conduct site qualification and/or pre-study monitoring visits.

2.1.22.3 Develop Clinical Monitoring Plan, to be jointly agreed upon by Contracting Officer Representative (COR).

2.1.22.4 Conduct Initial, Interim, and Close-Out monitoring visits. Offeror will provide draft monitoring reports within 10 days of visit and final monitoring reports within 30 days of visit.

2.1.22.5 Provide interim and final study data and site essential study documents to COR (Statistical Analysis Systems (SAS) dataset required) for inclusion in Trial Master File 30 days prior to (interim) and at completion of study (final).

2.1.22.6 Submission of study protocol and associated documentation to the study site (or affiliated) IRB and the US Army Human Research Protection Office (HRPO). The Contractor is responsible for amending protocols if necessary, and tracking any additional review and approval issues to resolution and submitting approved IRBs for each study site.

2.1.22.7 Prepare study protocols, informed consent forms, appendices, source documents, study specific procedures, and any other supporting documents required for the study.

2.1.23 Describe the statistical analysis plan (SAP) and data analysis plan (DAP). The SAP should include the rationale for how and why the test statistic was chosen among competing test statistics. The SAP should include appropriate statistical adjustment to account for repeated measures, multiplicity of tests and/or interim analyses. The SAP should document the commercial version and procedure(s) of statistical packages used for the analysis or demonstrated through theory or simulation studies in newly developed statistical methods. The SAP should include, but is not limited to the following: 1) primary objective, 2) primary endpoint definition, 3) all analysis variables, 4) any transformations/calculations defined, 5) all endpoints for analysis, 6) analysis time-points, 7) control of Type 1 error, 8) plan for handling missing data, 9) analysis dataset specifications (who and who will not be included), and 10)power analysis, sample size, and effect size. For research involving human subjects, specify the number of human subjects that will be recruited and enrolled. If multiple study sites are involved, state the approximate number to be enrolled at each site. The DAP should include how the data will be handled, including rules for stopping data collection, criteria for inclusion and exclusion of data, and how outliers will be defined and handled. For research involving human subjects, the DAP should include, but is not limited to the following: 1) target recruitment and enrollment graph, 2) target recruitment table, 3) consort flow diagram, and 4) data analysis processes.

2.2 PROGRAM MANAGEMENT TASKS

2.2.1 The contractor shall submit a Statement of Work (SOW) that describes how the Offeror will perform the technical tasks, and shall include a power analysis for justification of the technical approach enrollment goals and the cost proposal. The SOW will detail the critical subtasks, activities milestones and deliverables against the timeline. The contractor shall be responsible for the planning and execution of the contract Kickoff Meeting. This meeting shall be held no later than 30 days after the contract award date. The Contractor shall coordinate the details of this meeting (date, time and location) with the COR and Contract Specialist. Prior written approval of the COR is required for any change to the SOW.

2.2.2 The Contractor shall develop and maintain a Quality Management Plan (QMP). The QMP provides a description of the Contractor’s management steps to ensure that all activities of the project are managed in a sound, reasonable way to achieve the Government’s objectives and that all deliverables produced are acceptable prior to delivery to the Government. The QMP also describes the roles and responsibilities of the Government, the Contractor, and any subcontractors. The QMP provides appropriate mechanisms and access for the Government or its designee to audit the Contractor and/or its Subcontractors for regulatory compliance and quality assurance purposes. The Contractor shall submit quarterly status reports by the 15th of each month after award date. The Contractor shall submit a final draft and final technical report. The final draft report will be submitted NLT 45 days at end of the base year, and will incorporate comments by the government in the final report NLT 90 days after the base period.

2.2.2.1 The QMP must include the following information:

2.2.2.1.1 Project Deliverables & Project Processes: The key project deliverables aligned to milestones and processes required to achieve the milestones.

2.2.2.1.2 Customer Satisfaction: The customer satisfaction criteria describe when each deliverable is complete and acceptable as defined by the customer.

2.2.2.1.3 Process Quality Standards: The quality standards that are the “measures” used to determine if project work processes are being followed.

2.2.2.1.4 Stakeholder Expectations: Stakeholder expectations describe when a project process is effective as defined by the project stakeholders. Deliverables are evaluated against these criteria.

2.2.2.1.5 Quality Assurance Activities: The quality assurance activities that monitor and verify that the processes used to manage and create the deliverables are followed and are effective.

2.2.2.2 The following items shall be submitted as separate documents as part of the Contractor’s proposal:

2.2.2.2.1 Statement of Work (SOW)

2.2.2.2.2 Quality Management Plan (QMP)

2.3 The following items shall be submitted as indicated in the SOO and/or DD 1423 (Contract Data Requirements List (CDRL)) contained in Section J:

2.3.1 Programmatic Deliverables:

2.3.1.1 Quarterly Progress Reports

2.3.1.2 Draft Final and Final Report

2.3.1.3 QMP update

2.3.1.4 In-Progress Reviews

2.3.2 Data Management Deliverables:

2.3.2.1 End User Training Plan and Guides for Providers and Patients

2.3.2.2 Data Management Plan

2.3.2.3 Data Resource Sharing Plan

2.3.2.4 Intellectual Property Plan

2.3.2.5 Transition Implementation & Dissemination Plan

2.3.3 Human Subject Research Support Deliverables (if applicable):

2.3.3.1 Statistical Analysis Plan

2.3.3.2 Data Analysis Plan

2.3.3.3 Human Subject Recruitment, Informed Consent & Safety Procedures Plan

2.4 The Contractor shall provide qualified corporate representatives as needed for participation in the Joint DoD Mental Health Work Group. Meetings of the DoD Mental Health Work Group will be required on an intermittent basis or as needed.

2.5 The Contractor shall provide quarterly Progress, Status, and Management Reports that describe the progress made within the period, summarizes projected versus actual progress, reports costs incurred, reports monthly planned costs (spend plan) as well as a forecasted contract spend plan by government fiscal year (beginning Oct 1 and informs the Government of existing or potential problem areas. Include copies of the invoices submitted during the reporting period.

2.6 ADMINISTRATIVE TASKS

2.6.1 The Contractor shall provide the necessary qualified personnel, facilities, equipment, supplies, services, and subcontractors and related administrative and information technology support to accomplish the objectives and report any changes in key personnel assigned to this contract within seven (7) business days.

2.6.2 The Contractor shall allow the Government or its designee, to audit the contractor and/or its subcontractor(s) for regulatory compliance and quality assurance purposes.

2.6.3 The Contractor shall allow access to records, files, and other data derived from this work for the purposes of audit by the FDA and/or other Government entities.

2.6.4 The Contractor shall participate in appropriate quality assurance audits, provide responses to audit findings to the Government, and provide support during U.S. Army Quality oversight visits.

2.6.5 The Contractor shall provide a summary report within five (5) working days, of events that will cause more than a two (2) month delay in schedule or a 5% increase in cost estimate at completion.

2.6.6 The Contractor shall obtain site IRB approval, continuing review (in the intervals specified by the local IRB, but at a minimum annually) and approval by the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protection Office (HRPO) prior to research implementation. This administrative review requirement is in addition to the local IRB or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, and human subjects that are supported by the DoD.

2.7 TRAVEL

2.7.1 The Contractor shall provide qualified corporate representatives as needed for participation in the Joint DoD Mental Health Work Group. Participation in meetings of the DoD Mental Health Work Group will be required on an intermittent basis or as needed and may require travel to the national capital region at the expense of the Contractor.

2.7.2 The Contractor shall prepare for and participate in a 2-day Government In-Progress Review (IPR) meeting in the National Capital region annually. Travel will be at the expense of the Contractor.

2.7.3 The Contractor shall travel as necessary for data collection and study execution.

Section D - Packaging and Marking

DELIVERABLES

All deliverables required under this contract shall be packaged, marked and shipped in accordance with the instruction contained herein. At a minimum, all deliverables shall be marked with the contract number and Contractor name.

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLAUSES INCORPORATED BY REFERENCE

Section F - Deliveries or Performance

REPORTING REQUIREMENTS

MONTHLY TECHNICAL PROGRESS REPORTS

a. The contractor shall submit a Monthly Technical Progress Report covering work accomplished during each month of contract performance. It shall be brief, factual, and informal, and shall be prepared in accordance with the following:

(l) Cover containing:

(a) Contract number and title

(b) Type of report, sequence number of report, and period of performance being reported

(c) Contractor's name, address, and telephone number

(d) Principal Investigator

(e) Date of publication

(f) Contracting Officer's Representative

(2) Section I – Introduction and Project Summary (Purpose and Scope of Research Effort). A brief introduction covering the purpose and scope of the research effort (one paragraph summary).

(3) Section II – Progress

(a) Overall Progress Summary. A brief description of overall progress to date for the reporting period (one-two paragraphs summary).

(b) Individual Task Progress. A separate description for each task or other logical segment of work on which effort was expended during the report period, briefly describing the work that has been performed. Description shall include pertinent data and graphs in sufficient detail to explain any significant results achieved. List all tasks associated with the approved Statement of Work (SOW) including those with no activity performed for the period and status stating as such (i.e. have not started, no work conducted this period, started, delayed, % completed, etc.).

(4) Section III - Problems and Changes

(a) Problems Encountered. A description of current problems that may impede performance, including impact on expenditures, along with proposed corrective action. Report any changes (e.g. staff addition/removal/FTE reduction/increase, approaches, etc.) that happened and why. Note some changes require Contracting Officer’s review and expressed written approval through a formal award modification before implementation.

(b) Problems Anticipated. A description of anticipated problems that have a potential to impede progress and/or impact expenditures, and what corrective action is planned should the problem materialize. Report any changes (e.g. staff, approaches, etc.) planned and why. Note some changes require Contracting Officer’s review and expressed written approval through a formal award modification before implementation.

(5) Section IV - Next Month/Quarter Actions. A brief description of work to be performed during the next reporting period for each task. If no work is planned for a task then state so and why if appropriate.

(6) Section V - Administrative Comments - Description of proposed site visits and participation in technical meetings, journal manuscripts in preparation, coordination with other organizations conducting related work, etc.

(7) Section VI – Research Protocols and Regulatory Status

(a) Protocol Status. List each protocol planned for the project including title, protocol identifiers (i.e. IACUC number, ACURO number, name of regulatory review board, etc.), type of animals, number of animals, protocol PI, protocol site, etc., and note status of each (e.g. in development, submitted to regulatory agency such as IACUC, ACURO, FDA for review, approval date with name of regulatory authority, date of continuing review or rewrite review, amendments with brief statement of the changes and its status such as submitted and/or approved by which regulatory authority, etc.)

(b) Adverse Events. Describe any adverse events and actions taken.

(8) Section VII - A Gantt Chart/Quad Chart showing actual progress versus scheduled progress.

b. Monthly Technical Progress Reports shall be prepared by the seventh day following the month being reported, and shall be received within 10 days of the report month. The Monthly Technical Progress Report shall be submitted to the following addresses:

One Copy: Contract Specialist Email:

ANNUAL/FINAL TECHNICAL REPORTING REQUIREMENTS

Format Requirements:

a. Annual reports shall be prepared in accordance with the Research Performance Progress Report (RPPR). The RPPR is the uniform format for reporting performance progress on Federally-funded research projects and research-related activities. Annual reports shall provide a complete summary of the research results (positive or negative) to date in direct alignment to the approved Statement of Work (SOW). The importance of the report to decisions relating to continued support of the research cannot be over-emphasized. An annual report shall be submitted within 30 calendar days of the anniversary date of the award for the preceding 12 month period. If the award period of performance is extended by the USAMRAA Contracts Officer, then an annual report shall still be submitted within 30 days of the anniversary date of the award. A final report will be due upon completion of the extended performance date that describes the entire research effort.

b. A final report shall also be prepared in accordance with the RPPR and shall be submitted within 90 calendar days of the award performance end date. The report shall summarize the entire research effort, citing data in the annual reports and appended publications.

Although there is no page limitation for the reports, each report shall be of sufficient length to provide a thorough description of the accomplishments with respect to the approved SOW. Reports, in electronic format (PDF or Word file only), shall be submitted to https://ers.amedd.army.mil.

All reports shall have the following elements, in this order:

FRONT COVER:

Sample front cover is provided at http://mrmc.amedd.army.mil/index.cfm?pageid=researcher_resources.technical_reporting. The Accession Document (AD) Number should remain blank.

Distribution: Reports must include one of two distribution statements:

(1) Unlimited Distribution: If the distribution will be unlimited (i.e., approved for public release), choose the form entitled “Award/Contract Front Cover – Unlimited Distribution A.” Results of fundamental research should be public distribution except in rare and exceptional circumstances.

(2) Limited Distribution: If the distribution is to be limited, choose the form entitled “Award/Contract Cover – Limited Distribution B.” After report submission, the COR will review the appropriateness of using this distribution statement. The COR has the right to challenge the validity of any restrictive markings. Reports that may be eligible for limited distribution may be ones that contain proprietary data that is not to be released to the public. If so, mark the cover page as “Proprietary”. DO NOT USE THE WORD "CONFIDENTIAL" WHEN MARKING DOCUMENTS. The contractor shall maintain records sufficient to justify the validity of any restrictive markings. REPORTS NOT PROPERLY MARKED WILL BE DISTRIBUTED AS APPROVED FOR PUBLIC RELEASE.

For additional information regarding distribution statements, see DOD Instruction 5230.24 (available at http://www.dtic.mil/whs/directives).

For general information regarding report preparation, access the Research Resources, Technical Reporting, website at https://mrmc.amedd.army.mil/index.cfm?pageid=researcher_resources.technical_reporting.

STANDARD FORM 298: Sample SF 298 is provided at http://mrmc.amedd.army.mil/index.cfm?pageid=researcher_resources.technical_reporting. The abstract shall be provided in Block 14 and shall state the purpose, scope, and major findings and be an up-to-date report of the progress in terms of results and significance. Abstracts will be submitted to the Defense Technical Information Center (DTIC) and shall not contain proprietary information. Subject terms are keywords that may have been previously assigned to the proposal abstract or are keywords that may be significant to the research.

Pages shall be numbered. The number of pages shall include all pages that have printed data (including the front cover, SF 298, table of contents, and all appendices). Page numbers must match the numbering shown on the Table of Contents.

TABLE OF CONTENTS: Sample table of contents is provided at http://mrmc.amedd.army.mil/index.cfm?pageid=researcher_resources.technical_reporting.

Example Table of Contents Page No.

1. INTRODUCTION: Narrative that briefly (one paragraph) describes the subject, purpose and scope of the research.

2. KEYWORDS: Provide a brief list of keywords (limit to 20 words).

3. ACCOMPLISHMENTS: The PI is reminded that the contract organization is required to obtain prior written approval from the USAMRAA Contract s Officer whenever there are significant changes in the project or its direction.

What were the major goals of the project?

List the major goals of the project as stated in the approved SOW. If the application listed milestones/target dates for important activities or phases of the project, identify these dates and show actual completion dates or the percentage of completion.

Generally, the goals will not change from one reporting period to the next and are unlikely to change during the final reporting period. However, if the awarding agency approved changes to the goals during the reporting period, list the revised goals and objectives. Also explain any significant changes in approach or methods from the agency approved application or plan.

What was accomplished under these goals?

For this reporting period describe: 1) major activities; 2) specific objectives; 3) significant results or key outcomes, including major findings, developments, or conclusions (both positive and negative); and/or 4) other achievements. Include a discussion of stated goals not met. Description shall include pertinent data and graphs in sufficient detail to explain any significant results achieved. A succinct description of the methodology used shall be provided. As the project progresses to completion, the emphasis in reporting in this section should shift from reporting activities to reporting accomplishments.

What opportunities for training and professional development has the project provided?

If the project was not intended to provide training and professional development opportunities or there is nothing significant to report during this reporting period, state “Nothing to Report.”

Describe opportunities for training and professional development provided to anyone who worked on the project or anyone who was involved in the activities supported by the project. “Training” activities are those in which individuals with advanced professional skills and experience assist others in attaining greater proficiency. Training activities may include, for example, courses or one-on-one work with a mentor. “Professional development” activities result in increased knowledge or skill in one’s area of expertise and may include workshops, conferences, seminars, study groups, and individual study. Include participation in conferences, workshops, and seminars not listed under major activities.

How were the results disseminated to communities of interest?

If there is nothing significant to report during this reporting period, state “Nothing to Report.”

Describe how the results were disseminated to communities of interest. Include any outreach activities that were undertaken to reach members of communities who are not usually aware of these project activities, for the purpose of enhancing public understanding and increasing interest in learning and careers in science, technology, and the humanities.

What do you plan to do during the next reporting period to accomplish the goals?

If this is the final report, state “Nothing to Report.”

Describe briefly what you plan to do during the next reporting period to accomplish the goals and objectives.

4. IMPACT: This component is used to describe ways in which the work, findings, and specific products of the project have had an impact during this reporting period. Describe distinctive contributions, major accomplishments, innovations, successes, or any change in practice or behavior that has come about as a result of the project relative to:

What was the impact on the development of the principal discipline(s) of the project?

If there is nothing significant to report during this reporting period, state “Nothing to Report.”

Describe how findings, results, techniques that were developed or extended, or other products from the project made an impact or are likely to make an impact on the base of knowledge, theory, and research in the principal disciplinary field(s) of the project. Summarize using language that an intelligent lay audience can understand (Scientific American style).

How the field or discipline is defined is not as important as covering the impact the work has had on knowledge and technique. Make the best distinction possible, for example, by using a “field” or “discipline,” if appropriate, that corresponds with a single academic department (i.e., physics rather than nuclear physics).

What was the impact on other disciplines?

If there is nothing significant to report during this reporting period, state “Nothing to Report.”

Describe how the findings, results, or techniques that were developed or improved, or other products from the project made an impact or are likely to make an impact on other disciplines.

What was the impact on technology transfer?

If there is nothing significant to report during this reporting period, state “Nothing to Report.”

Describe ways in which the project made an impact, or is likely to make an impact, on commercial technology or public use, including:

What was the impact on society beyond science and technology?

If there is nothing significant to report during this reporting period, state “Nothing to Report.”

Describe how results from the project made an impact, or are likely to make an impact, beyond the bounds of science, engineering, and the academic world on areas such as:

5. CHANGES/PROBLEMS: The Project Director/Principal Investigator (PD/PI) is reminded that the contract organization is required to obtain prior written approval from the awarding agency Contracts Officer whenever there are significant changes in the project or its direction. If not previously reported in writing, provide the following additional information or state, “Nothing to Report,” if applicable:

Changes in approach and reasons for change

Describe any changes in approach during the…