Downloaded from https://www.everyspec.com of investigational drugs and biologicals (vaccines) in humans. The USAMRMC, or any other sponsor of an investiga- tional drug or biological, must file an Investigational New Drug (IND) application with the FDA prior to the use of the product on human volunteers. Medical Devices may require the filing of an Investigational Device Exception (IDE) with the FDA (21 CFR, Part 812). Documentation of receipt of an IND (or IDE, if required) by the FDA, and an approval letter from the human use review committee for the individual study protocols, will be submitted with each OTP covering tests with investigational products.
This documentation replaces the TEMP requirement and provides authority for testing investigational drugs, biologicals, and devices in human volunteers. c. All TEMPs will contain a Requirements/Test Crosswalk Matrix as an attachment that links COIC, KPP, AOA, measures of effectiveness, measures of performance, critical technical parameters, and reference paragraphs of the CDD and/or CPD for a particular requirement with the actual test, or other data source, that will satisfy the CDD and/ or CPD requirement. d.
The process of developing, reviewing, and approving TEMPs will produce a valuable document satisfying the needs of all key customers, and will ensure important program MSs are not overlooked. (1) The process will be implemented in accordance with the concepts of the DOD IPPD philosophy. (2) The process will utilize the T&E subgroup (T&E WIPT) of the Integrating IPT as a working entity consisting of key process participants. This subgroup is empowered to perform the work and make decisions that reflect the needs of all customers. (3) The policy described in paragraph b above applies to all acquisition program TEMPs that require HQDA approval.
Other programs will use the TEMP process to document their T&E strategy; however the TEMP format may be tailored. (4) The T&E WIPT will develop the TEMP and will interact with the other subgroups of the Integrating IPT examining requirements and tradeoffs involving cost, schedule, and performance. In addition, in lieu of using “To Be Determined” (TBDs) in the TEMP, the T&E WIPT will state the issue or facts currently available and the planned resolution date (that is, when the current TBD will no longer be a TBD). (5) It is recommended that the T&E WIPT meeting be convened for the purpose of final TEMP coordination.
T&E WIPT members may convene after each member of the subgroup has been provided a final draft document with sufficient time for review by the member’s leadership. This review will ensure that the member’s position is sound and will not be overturned later. Coordination of the TEMP by the T&E WIPT at the final coordination meeting will be denoted by the signatures of the members who are their organizations’ authorized signatories on the T&E WIPT Coordination Sheet of the TEMP. The PM shall attempt to resolve known issues prior to submitting the TEMP into the formal approval process.
If unable to do so, the PM will highlight the issue and provide a recommendation to the appropriate decision maker prior to submitting the TEMP for approval. (6) The PM signs the T&E WIPT-coordinated TEMP on the TEMP approval page. No more than 30 calendar days will elapse between the signing of the TEMP by the PM and the signature by the Army T&E Executive. (7) Specific procedures will be developed by each PM to ensure that a T&E WIPT-coordinated TEMP, complete with all Army signatures on the TEMP approval page except for the Army T&E Executive, is delivered to TEMA for Army T&E Executive signature.
Representatives of the Program Executive Officer (PEO), the combat developer or functional proponent, and the USATEC are empowered to sign the TEMP approval page. A recommended goal is for all signatures to be obtained during the final T&E WIPT TEMP coordination meeting. The PEO shall monitor the TEMP approval staffing and assist in the resolution of issues that may prohibit TEMP approval. (8) Within 10 days of receipt, TEMA will coordinate and assist in resolving any issue prior to submitting the TEMP to the ARMY T&E Executive for HQDA approval. 10–3. System Evaluation Plan a. The System Evaluation Plan (SEP) documents the integrated T&E strategy.
This is the evaluation strategy and the test/simulation execution strategy that will be used throughout the system acquisition life-cycle. It addresses system COIC, critical technical parameters and additional evaluation focus areas, identifies data needs and sources, the approach to be used for the evaluation of the system, specifies the analytical plan, and identifies program constraints. The SEP details the evaluator’s planned actions for the evaluation of the system, and is updated as needed. b. The system evaluator prepares the SEP in coordination with the T&E WIPT. The SEP does not require T&E WIPT approval.
It is approved by the command executing the evaluation, transmitted through the Army T&E Executive and forwarded to the DOT&E for information when the system is on the OSD T&E Oversight List. c. The SEP provides guidance for development of EDPs. 10–4. Event Design Plan a. An EDP documents the results of planning the test design methodology and the data collection, reduction and reporting processes required for the specific event or combination of events. For LFTs, see paragraph 10–14 for EDP requirements. It is developed to ensure that the event will produce the required data as outlined in the approved SEP. b.
The term event applies to any activity that produces data for evaluation purposes. It refers to any test, model, simulation, experiment, demonstration, and data collection during training exercises. (See para 6–4.) 32 AR 73–1 • 1 August 2006