ISRI_STATEMENT_OF_OBJECTIVES_CONSOLIDATED_JPC_5_EDITS_11.9.16_Final.docx

STATEMENT OF OBJECTIVES

DEPARTMENT OF DEFENSE JOINT PROGRAM COMMITTEE-5 (JPC5),

MILITARY OPERATIONAL MEDICINE RESEARCH PROGRAM (MOMRP),

PSYCHOLOGICAL HEALTH AND RESILIENCE PROGRAM AREA

UTILIZING IMPLEMENTATION SCIENCE TO OPTIMIZE SELECTIVE EVIDENCE-BASED PTSD TREATMENT, TELE-BEHAVIORAL HEALTH INTERVENTIONS AND/OR SERVICE-WIDE ADOPTION AND USE OF THE DOD’S BEHAVIORAL HEALTH DATA PORTAL (BHDP)

1.0 GENERAL

The Department of Defense, 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

Research documenting deployment and reintegration stressors and mental health issues among SMs and their families has made it possible to estimate the need for services and preventive programs designed to reduce the impact of mental health issues on SMs. A myriad of barriers constrain mental health treatment accessibility, engagement, and utilization.

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. EBP has encountered barriers common to most diffusion efforts resulting 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.

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). 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. The effective dissemination and implementation of evidence-based health interventions within military settings are important cornerstones to expanding the availability of quality health and mental health services.

1.2 OBJECTIVE

This requirement provides funding for research that utilizes implementation science to optimize selective evidence-based PTSD treatments, tele-behavioral health interventions and/or service-wide adoption, utilization, and optimization of the DoD’s Behavioral Health Data Portal. Dissemination and implementation (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 includes models for implementing and disseminating evidence-based interventions throughout the Military Health System (MHS), or interventions that target multiple levels within the MHS (e.g., health promotion interventions that target multiple levels of military personnel within a military setting) or design studies that will accurately and transparently assess the outcomes of dissemination and implementation efforts. The key performance objective is to utilize implementation science to accelerate translation and adoption of end-user focused, evidence-based 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.

This requirement seeks to support service-wide adoption and use of clinical outcome measurements (Common Data Elements) to inform clinical behavioral health practice and adherence to evidence-based practices (e.g., provider adherence, decreasing barriers, comparison of provider vs patient report via BHDP).

2.0 UTILIZING IMPLEMENTATION SCIENCE PRINCIPLES AND OUTCOME MEASUREMENTS TO OPTIMIZE SELECT EVIDENCE-BASED PTSD TREATMENT DELIVERY; ADAPTATIONS OF EBT TO TELE-BEHAVIORAL HEALTH DELIVERY; OR SERVICE-WIDE ADOPTION AND USE OF THE DOD’S BEHAVIORAL HEALTH DATA PORTAL (BHDP)

2.1 TECHNICAL TASKS

2.1.1 The contractor shall provide clinical study, technical, and administrative support to optimize evidence-based PTSD treatment, tele-behavioral health interventions or service-wide adoption and use of the DoD’s BHDP. The contractor is responsible for performing all clinical, technical, and administrative support tasks that align with at least one of the following technical tasks:

2.1.1.1 Evaluate the feasibility of utilizing implementation science and outcome measurements to optimize evidence based PTSD interventions (including but not limited to prolonged exposure therapy, cognitive processing therapy, Eye Movement Desensitization and Reprocessing) currently under consideration by DOD for broader scale implementation. Efforts 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 objective is to utilize implementation science to accelerate translation and adoption of end-user focused, evidence-based interventions to inform best practice guidelines, reduce variations in clinical practice, and setting quality standards for the military.

2.1.1.2 Evaluate the feasibility of utilizing implementation science and outcome measurements to optimize evidence based tele-behavioral health interventions currently under consideration by DOD to identify best practices for facilitating treatment fidelity, adherence, optimization of treatment sessions, standardization of processes, and identification/remediation of technical barriers to treatment. An acceptable proposal would improve access to care by utilizing implementation science to optimize the reach of therapy from provider’s office to the patient’s home, office, barracks, etc. Consideration of issues associated with licensure rules and providing care across state lines would need to be addressed.

2.1.1.3 Utilize principles of implementation science and outcome measurements to optimize Service-wide adoption and use the DoD’s Behavioral Health Data Portal (http://armymedicine.mil/Pages/BHDP.aspx).

2.1.2 Collaborations with military treatment facilities, populations and resources are essential and a requisite of this requirement.

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 application 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. For applications that include an intramural collaborator, include a letter from the collaborator’s Commander or Commanding Officer at the intramural organization that authorizes the collaborator’s involvement.

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 Propose timeline spanning the lifetime of the research effort, with key milestones delineated

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 the training of providers and treatment fidelity issues. Additional considerations include timing, dosing, quantity, and delivery method of interventions, for example, to coincide with important military lifecycle stages or transitions as well as existing infrastructure and 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 involving animal research do not meet the intent of this requirement.

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

2.1.7.3 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, specifically patients.

2.1.8 Explain the applicability of the proposed work to utilize implementation science 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. Show 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 well the proposed approach includes models for implementing evidence-based interventions throughout the MHS or interventions that target multiple levels of military personnel within a military environment. Elucidate to what extent the proposed approach addresses the potential immediate or long-term PH and well-being of SMs, their families, and/or communities.

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

2.1.10 Identify timelines for critical events that must be accomplished in order for the project to be successful in terms of cost, schedule and performance.

2.1.11 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.

2.1.12 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:

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

2.1.12.2 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.

2.1.12.3 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.

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

2.1.12.5 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.

2.1.12.6 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.

2.1.13 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 may be required to register their clinical trials on Clinicaltrials.gov (https://clinicaltrials.gov/).

2.1.14 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.

2.1.15 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.

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

2.1.16. Describe the Active Duty military population(s) used in the proposed research project, the appropriateness of the population(s) for the proposed study, and the feasibility of accessing the population.

2.1.16.1 State explicitly how the proposed work will have an impact on implementing evidence-based intervention throughout the MHS or interventions that target multiple levels within the MHS (e.g., health promotion interventions that target multiple levels of military personnel within a military setting).

2.1.17 Intangible property acquired, created or developed under this award will be subject to all rights and responsibilities established at 2 CFR 200.315. Should the applicant intend to use, in the performance of this program, pre-existing, legally protected and perfected intangible property and for which no Federal funds had been used in the development of said property, the applicant must:

2.1.17.1 Clearly identify all such property

2.1.17.2 Identify the cost to the Federal government for use or license of such property if applicable; or

2.1.17.3 Provide a statement that no property meeting this definition will be used on this project.

2.1.18. Provide a description of any intellectual property ownership including any appropriate intellectual and materiel property plan among participating organizations (if applicable), and any impact of intellectual property issues on product development and subsequent Government access to products supported by this requirement. If applicable state whether the PI has access to all intellectual property rights necessary for development and commercialization, and evidence that the Government has the ability to access such products or technologies. Provide a plan for resolving intellectual and material property issues among participating organizations.

2.1.19 Provide a transition plan to include information on the methods and strategies proposed to move the anticipated research outcomes to the next phase of research or delivery to the military after successful completion of the contract. The transition plan should include the components listed below:

2.1.19.1 Describe the funding, schedule and milestones that will be used to bring the outcomes to the next level of development (e.g., specific potential industry partners, specific funding opportunities to be pursued). Detail the timelines toward implementation.

2.1.19.2 Describe collaborations and other resources for providing continuity of development, including proposed development or modification of Clinical Practice Guidelines and recommendations, provider training materials, patient brochures, and other clinical support tools, scientific journal publications, models, simulations, and applications are established and/or achievable.

2.1.19.3 Describe the involvement of appropriate intellectual property, licensing and/or business professionals.

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

2.1.21 For research involving human subjects:

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

2.1.21.2 Describe the methods that will be used to recruit a sample cohort from the accessible population (e.g., convenience, simple random, stratified random).

2.1.21.3 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.

2.1.21.4 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).

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

2.1.21.6 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.

2.1.21.7 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.

2.1.21.8 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

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

2.1.21.9.1 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.

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

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

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

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

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

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

2.1.22.4 Include information regarding the timing and location of the consent process.

2.1.22.5 Address issues relevant to the mental capacity of the potential human subject (e.g., altered capacity due to administration of any mind-altering substances such as tranquilizers, conscious sedation or anesthesia, brain injury, stress/life situations, or human subject age), if applicable.

2.1.22.6 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.

2.1.22.7 Describe the plan for the consent of the individual’s Legally Authorized Representative (LAR) to be obtained prior to the human subject’s participation in the study. State law defines who may act as the LAR. The local Institutional Review Board (IRB) of record should be consulted for guidance regarding who can serve as LAR for research at the study site. Note: The PI must describe a clear intent to benefit for human subjects who cannot give their own consent to participate in the proposed research or clinical trial to be in compliance with Title 10 United States Code Section 980 (10 USC 980) (https://www.gpo.gov/fdsys/pkg/USCODE-2014-title10/pdf/USCODE-2014-title10-subtitleA-partII-chap49-sec980.pdf).

2.1.22.8 Assent. If minors or other populations that cannot provide informed consent are included in the proposed research or clinical trial, a plan to obtain assent (agreement) from those with capacity to provide it, or a justification for a waiver of assent, should be provided. PIs should consult with their local IRB to identify the conditions necessary for obtaining assent.

2.1.23 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.

2.1.24 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.

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

2.1.24.2 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.

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

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

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

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

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

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

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

2.1.25.4 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.

2.1.25.5 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).

2.1.25.6 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.

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

2.1.26 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, and 9) 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) interim analysis plan, and 4) planned 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 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 Contracting Officer’s Representative (COR) and Contract Specialist.

2.2.2. The Contractor shall develop and maintain an Integrated Master Schedule (IMS) and Contract Work Breakdown Structure (CWBS) by logically networking detailed program activities. The IMS shall contain the planned events and milestones, accomplishments and activities from contract award to the completion of contract. The IMS shall be updated semi-annually to show task progress, percent completion, and schedule slippage. Prior written approval of the COR is required for any major changes.

2.2.3. The CWBS elements shall be extended to define the complete contract scope and shall be to a depth and breadth necessary to accurately describe the proposed effort, to a minimum of Level 4. The CWBS shall be updated annually.

2.2.4. 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 monthly 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.

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

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 Semi-Annual IMS update (sect. 2.2.2.)

2.3.1.2 Annual CWBS update (sect. 2.2.3.)

2.3.1.3 Monthly Progress Reports

2.3.1.4 Draft Final and Final Report

2.3.1.5 QMP update

2.3.1.6 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 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 for management and oversight of project. Meetings of the DoD Mental Health Work Group will be required on an intermittent basis, frequency and times to be coordinated through the COR.

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 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 is supported by the DoD.