ISRI_RFP_DD1423-1_CDRL_PTSD_TX_FINAL_18APR17.pdf

DD FORM 1423-1, FEB 2001

CONTRACT DATA REQUIREMENTS LIST

(1 Data Item)

PREVIOUS EDITION MAY BE USED.

Form Approved OMB No. 0704-0188

The public reporting burden for this collection of information is estimated to average 110 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to the Department of Defense, Executive Services and Communications Directorate (0704-0188). Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. Please do not return your form to the above organization. Send completed form to the Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.

A. CONTRACT LINE ITEM NO. B. EXHIBIT C. CATEGORY:

TDP ________ TM _______ OTHER

D. SYSTEM/ITEM E. CONTRACT/PR NO. F. CONTRACTOR

1. DATA ITEM NO. 2. TITLE OF DATA ITEM 3. SUBTITLE

4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE 6. REQUIRING OFFICE

7. DD 250 REQ

8. APP CODE

9. DIST STATEMENT

REQUIRED

10. FREQUENCY

11. AS OF DATE

12. DATE OF FIRST SUBMISSION

13. DATE OF SUBSEQUENT

SUBMISSION

14. DISTRIBUTION

a. ADDRESSEE

b. COPIES

Draft Final

Reg Repro

15. TOTAL

16. REMARKS

17. PRICE GROUP

18. ESTIMATED

TOTAL PRICE

G. PREPARED BY H. DATE I. APPROVED BY J. DATE

Page of Pages

CONTRACT DATA REQUIREMENTS LIST

(1 Data Item)

A. CONTRACT LINE ITEM NO. B. EXHIBIT C. CATEGORY:

TDP ________ TM _______ OTHER

D. SYSTEM/ITEM E. CONTRACT/PR NO. F. CONTRACTOR

16. REMARKS (Continued)

DD FORM 1423-1, FEB 2001 Page of Pages

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INSTRUCTIONS FOR COMPLETING DD FORM 1423

(See DoD 5010.12-M for detailed instructions.)

FOR GOVERNMENT PERSONNEL

Item A. Self-explanatory.

Item B. Self-explanatory.

Item C. Mark (X) appropriate category: TDP - Technical Data Package;

TM - Technical Manual; Other - other category of data, such as "Provisioning,""Configuration Management," etc.

Item D. Enter name of system/item being acquired that data will support.

Item E. Self-explanatory (to be filled in after contract award).

Item F. Self-explanatory (to be filled in after contract award).

Item G. Signature of preparer of CDRL.

Item H. Date CDRL was prepared.

Item I. Signature of CDRL approval authority.

Item J. Date CDRL was approved.

Item 1. See DoD FAR Supplement Subpart 4.71 for proper numbering.

Item 2. Enter title as it appears on data acquisition document cited in Item 4.

Item 3. Enter subtitle of data item for further definition of data item (optional entry).

Item 4. Enter Data Item Description (DID) number, military specification number, or military standard number listed in DoD 5010.12-L (AMSDL), or one-time DID number, that defines data content and format requirements.

Item 5. Enter reference to tasking in contract that generates requirement for the data item (e.g., Statement of Work paragraph number).

Item 6. Enter technical office responsible for ensuring adequacy of the data item.

Item 7. Specify requirement for inspection/acceptance of the data item by the Government.

Item 8. Specify requirement for approval of a draft before preparation of the final data item.

Item 9. For technical data, specify requirement for contractor to mark the appropriate distribution statement on the data (ref. DoDD 5230.24).

Item 10. Specify number of times data items are to be delivered.

Item 11. Specify as-of date of data item, when applicable.

Item 12. Specify when first submittal is required.

Item 13. Specify when subsequent submittals are required, when applicable.

Item 14. Enter addressees and number of draft/final copies to be delivered to each addressee. Explain reproducible copies in Item 16.

Item 15. Enter total number of draft/final copies to be delivered.

Item 16. Use for additional/clarifying information for Items 1 through 15.

Examples are: Tailoring of documents cited in Item 4; Clarification of submittal dates in Items 12 and 13; Explanation of reproducible copies in Item 14.; Desired medium for delivery of the data item.

FOR THE CONTRACTOR

Item 17. Specify appropriate price group from one of the following groups of effort in developing estimated prices for each data item listed on the DD Form 1423.

a. Group I. Definition - Data which is not otherwise essential to the contractor's performance of the primary contracted effort (production, development, testing, and administration) but which is required by DD Form 1423.

Estimated Price - Costs to be included under Group I are those applicable to preparing and assembling the data item in conformance with Government requirements, and the administration and other expenses related to reproducing and delivering such data items to the Government.

b. Group II. Definition - Data which is essential to the performance of the primary contracted effort but the contractor is required to perform additional work to conform to Government requirements with regard to depth of content, format, frequency of submittal, preparation, control, or quality of the data item.

Estimated Price - Costs to be included under Group II are those incurred over and above the cost of the essential data item without conforming to Government requirements, and the administrative and other expenses related to reproducing and delivering such data item to the Government.

c. Group III. Definition - Data which the contractor must develop for his internal use in performance of the primary contracted effort and does not require any substantial change to conform to Government requirements with regard to depth of content, format, frequency of submittal, preparation, control, and quality of the data item.

Estimated Price - Costs to be included under Group III are the administrative and other expenses related to reproducing and delivering such data item to the Government.

d. Group IV. Definition - Data which is developed by the contractor as part of his normal operating procedures and his effort in supplying these data to the Government is minimal.

Estimated Price - Group IV items should normally be shown on the DD Form 1423 at no cost.

Item 18. For each data item, enter an amount equal to that portion of the total price which is estimated to be attributable to the production or development for the Government of that item of data.

These estimated data prices shall be developed only from those costs which will be incurred as a direct result of the requirement to supply the data, over and above those costs which would otherwise be incurred in performance of the contract if no data were required. The estimated data prices shall not include any amount for rights in data. The Government's right to use the data shall be governed by the pertinent provisions of the contract.

DD FORM 1423-1 (BACK), FEB 2001

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BLK 11, 12, 13- The contractor shall prepare and send Technical Data Packages to the Government within 30 days of completion of each of the following tasks, as applicable, along with data requirements.

1. All tasks and milestones outlined in the contractor's Statement of Work (SOW)

(1) Dissemination and Implementation (D&I) Science Framework/Model and Technical Manual- summarize the D&I science framework and model that is generalizable to interventions and tools and applicable to the military context. Provide list of relevant published research.

a) apply the model to a DoD identified evidence-based PTSD treatment

b) evaluate the D&I approach ability to accelerate translation and adoption of end-user focused, evidence-based PTSD treatment, inform best practice guidelines, reduce clinical practice variations, and set quality standards for the military.

(2) Best Practices Process - summarize the process for identifying best practices for facilitating implementation of the key D&I science elements and provide a list of relevant literature.

(3) D&I Science Applicability - provide discussion of data from the D&I science model regarding applicability to all branches of the military (Army, Navy, Air force, Marines) as well as Special Operations.

(4) D&I Results – for the proposed technical task, summarize in detail the data and conclusions on D&I strategies that may include, but are not limited to the following:

a) Methods/models to promote the integration of evidence-based PTSD treatment interventions into healthcare practice and policy

b) methods/models promoting research finding integration into healthcare systems

c) Methods/models to promote the integration of evidence-based PTSD treatment interventions across all branches of the military

d) Methods/models for disseminating and implementing evidence-based PTSD treatment interventions throughout a setting or service system (e.g., throughout a military base, or within the military healthcare system)

e) Provide finalized D&I manual for the specified intervention/tool

(5) For PTSD Intervention D&I- summarize the strategy, process, and data derived from identifying, measuring, disseminating, and implementing best practices facilitating:

a) Treatment fidelity

b) Treatment adherence

c) Optimization of treatment sessions

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e) Identification/remediation of technical barriers to treatment

2. For Applied Research Applied Research Data – provide the data that result from refining concepts and ideas into potential solutions with a view toward evaluating technical feasibility of behavioral health interventions, clinical guidance, emerging approaches and technologies, and/or promising new products. Applied research data may involve human subjects.

(1) Research Objectives - provide data derived from the applied research objectives defined in the potential solution or equivalent that include, but are not limited to the following:

a) Behavioral health interventions

b) Clinical guidance

c) Emerging approaches and technologies

d) Promising new products

(2) Mitigation Strategy - provide detailed mitigation strategy for study implementation and execution to include human subjects enrollment, if applicable.

3. For Clinical Trials Clinical Trials Data – provide the data that result from a prospective accrual of human subjects where an intervention (e.g., D&I model, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction.

(1) Clinical Trial Timelines - provide timelines defined in the clinical protocol that include, but are not limited to the following:

a) Timeline that includes sequence and timing of key regulatory tasks and approvals

b) Timeline of events that must be accomplished in order for the project to be successful in terms of cost, schedule, and performance

(2) Clinical Trial Data Analysis Plan (DAP) – 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:

a) Recruitment and enrollment graph of real-time data

b) Recruitment table of real-time data

c) Consort flow diagram of real-time data

d) Interim Analysis Data

e) Raw Data

f) Data analysis processes

g) Final Data

(3) Clinical Trial Statistical Analysis Plan (SAP) - 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:

a) Primary objective

b) Primary endpoint definition

c) All analysis variables

d) Any transformations/calculations defined

e) All endpoints for analysis

f) Analysis time-points

g) Control of Type 1 error

h) Plan for handling missing data

i) Analysis dataset specifications (who and who will not be included)

j) Power analysis, sample size, and effect size (4)Plan for regulatory approval should include, but is not limited to the following:

a) Timeline that includes sequence and timing of key regulatory activities, tasks, and decisions points

b) Regulatory communication plan

c) Previous regulatory communication information

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