Tr-21 software

Does the application include an evaluation plan demonstrating how the proposed diagnostic technology will be assessed for effectiveness?

Are confounding factors such as alcohol, drugs, nutritional supplements, etc. To what extent is the proposed platform amenable for validation and testing for sensitivity and accuracy using clinical samples? To what extent does the application address sources of error that might affect disease diagnostics and incorporate Process Analytical Technologies, systems engineering approaches, Quality by Design principles, human-factors-engineering principles, usability-engineering principles, and ASSURED principles?

To what extent does the proposed FDA Approval Plan describe the expected regulatory pathway for the technology, foreseeable regulatory risks that could impact the technology development, and how the technology would fit with current standard of care?

To what extent is the proposed evaluation plan appropriate for the goals of the project? Does the application adequately address the following, if applicable:. Is the trial appropriately designed to conduct the research efficiently? Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection?

Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate?

Is there a plan to obtain required study agent s? Does the application propose to use existing available resources, as applicable?

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site s or at center laboratories, as applicable?

Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award? Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?

Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the application adequately address the capability and ability to conduct the trial at the proposed site s or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items. To what extent are the listed milestones and Gantt chart appropriate for the goals of the project a platform to detect a total of at least twenty diseases including at least one wearable for a chronic disease by the end of the fifth year? To what extent are the milestones relevant, measurable, achievable, result-focused and time-bound?

Specific to applications involving clinical trials Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment?

Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources e. Are potential challenges and corresponding solutions discussed e. For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1 risk to subjects, 2 adequacy of protection against risks, 3 potential benefits to the subjects and others, 4 importance of the knowledge to be gained, and 5 data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1 the justification for the exemption, 2 human subjects involvement and characteristics, and 3 sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: 1 description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; 2 justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; 3 interventions to minimize discomfort, distress, pain and injury; and 4 justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals.

Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score. Reviewers will assess the information provided in this section of the application, including 1 the Select Agent s to be used in the proposed research, 2 the registration status of all entities where Select Agent s will be used, 3 the procedures that will be used to monitor possession use and transfer of Select Agent s , and 4 plans for appropriate biosafety, biocontainment, and security of the Select Agent s.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group s convened by NCATS, in accordance with NIH peer review policy and procedures , using the stated review criteria. As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit generally the top half of applications under review will be discussed and assigned an overall impact score. Appeals of initial peer review will not be accepted for applications submitted in response to this FOA. Applications will compete for available funds with all other recommended applications submitted in response to this FOA.

Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:. A formal notification in the form of a Notice of Award NoA will be provided to the applicant organization for successful applications.

The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official. Awardees must comply with any funding restrictions described in Section IV. Funding Restrictions. Selection of an application for award is not an authorization to begin performance.

Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

NIH expects registration and results reporting of all trials whether required under the law or not. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies clinical trials to ensure the safety of participants and the validity and integrity of the data.

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions including licensed products and devices for a purpose other than that for which they were licensed in humans under a research protocol must be performed under a Food and Drug Administration FDA investigational new drug IND or investigational device exemption IDE.

Recipients of federal financial assistance FFA from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.

This includes ensuring programs are accessible to persons with limited English proficiency. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U. The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism rather than an "acquisition" mechanism , in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities.

Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the Principal Investigator and appropriate Project Leaders and will require appropriate acknowledgement of NIH support.

Timely publication of major findings is encouraged. NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. NIH Project Scientist s will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination. NIH Project Scientists s will:. An NIH Program Official will be responsible for the normal programmatic stewardship of the award and will be named in the award notice.

The program official s will:. Recipient members of the SC will be required to accept and implement policies approved by the SC. Other government staff may attend the Steering Committee meetings if their expertise is required for specific discussions. The Steering Committee will:. Any disagreements that may arise in scientific or programmatic matters within the scope of the award between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened.

It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee.

The Terms and Conditions of Award will include references to the currently approved versions of the Sharing Plans for Resources and Data. Before the initial award is made, NIH and the recipients may negotiate changes or additions to the versions of these plans in the application. Changes will be documented by an exchange of correspondence and the updated plans will become part of the Terms and Conditions of a revised Notice of Award.

The Federal Funding Accountability and Transparency Act of Transparency Act , includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY or later.

In accordance with the regulatory requirements provided at 45 CFR The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system currently FAPIIS. This is a statutory requirement under section of Public Law , as amended 41 U. As required by section of Public Law , all information posted in the designated integrity and performance system on or after April 15, , except past performance reviews required for Federal procurement contracts, will be publicly available.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Danilo Tagle, Ph. Leah Tolosa Croucher, Ph. Recently issued trans-NIH policy notices may affect your application submission. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Department of Health and Human Services. Part 1. Overview Information. Participating Organization s. Components of Participating Organizations. Funding Opportunity Title. Activity Code. Announcement Type. Related Notices. Companion Funding Opportunity. Number of Applications.

Assistance Listing Number s. Funding Opportunity Purpose. Key Dates. Posted Date. Open Date Earliest Submission Date. Letter of Intent Due Date s. Expiration Date. Due Dates for E.

Required Application Instructions. Section I. Funding Opportunity Description. Section II. Award Information. Eligibility Information. Section IV. Application and Submission Information. Section V. Application Review Information. Section VI. Award Administration Information. Section VII. Agency Contacts. Section VIII. Other Information. Part 2. Full Text of Announcement. Purpose The purpose of the SCENT FOA is to enable the development of a disease-agnostic platform for the diagnosis and monitoring of a wide range of disease conditions thereby catalyzing the use of the technology for the clinic and beyond.

Developed hydrographs are routed through stream and valley reaches as well as through reservoirs. Hydrographs are combined from tributaries with those on the main stream. Branching flow diversion , and baseflow can also be accommodated. WinTR may be used to evaluate flooding problems, alternatives for flood control reservoirs, channel modification, and diversion , and impacts of changing land use on the hydrologic response of watersheds.

Compatible Downloads. It allows you to use the application installed PC as a server for data storage. A web application for mobile devices such as smartphones and tablets. Software that is used to make changes to the adjustment settings which operate on measured readings. A mobile application for uploading data to cloud designed to work with TR4 data loggers.

Application that can be used to measure the signal strength between the RTR Series Base Units, Remote Units, and Repeaters, as well as monitor radio frequency interference. Before downloading, please check compatibility and operating environment specifications, as well as, other information such as applicable restrictions that may be included in "Read First". This software has been specifically designed for use only with Hi for Windows allowing you to control all settings, data downloading and graph creation, as well as other functions.