Standardizing Data and Metadata from Wearable Devices (R01 Clinical Trial Not Allowed)

Standardizing Data and Metadata from Wearable Devices (R01 Clinical Trial Not Allowed) is sponsored by National Institute of Mental Health (NIMH), National Institutes of Health (NIH). This Notice of Funding Opportunity (NOFO) supports the creation of standards for data, metadata, and related coordination activities to allow researchers to easily access and integrate data from personal tracking devices (including wearables and cell phones) for analysis related…

Expired PAR-24-250: Standardizing Data and Metadata from Wearable Devices (R01 Clinical Trial Not Allowed) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Mental Health ( NIMH ) Funding Opportunity Title Standardizing Data and Metadata from Wearable Devices (R01 Clinical Trial Not Allowed) R01 Research Project Grant March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Funding Opportunity Number (FON) Companion Funding Opportunity See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose Wearable technology shows promise in providing information that can be used to create biomarkers of various diagnostic groups that have relevance to mental illness. However, there are barriers related to multiple and sometimes proprietary data standards that make data aggregation difficult from existing devices.

The purpose of this Notice of Funding Opportunity (NOFO) is to support the creation of standards for data as well as metadata and related coordination activities that will allow researchers to easily access data from personal tracking devices and integrate those data for subsequent data analysis.

The recipients will be expected to partner with device manufacturers, the researcher community, and other interested parties such as ethics experts if the effort is going to be successful.

It is expected that the recipient will create standards for personal tracking device data that serve the same purpose as the Digital Imaging and Communications in Medicine (DICOM) or Neuroimaging Informatics Technology Initiative (NIfTI) formats and standards do for medical image files.

Those medical image file standards have allowed secondary data analysis and have resulted in many software packages and workflows for secondary data analysis.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due dates Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. 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 Section I.

Notice of Funding Opportunity Description Investigator-initiated applications administered by the National Institute of Mental Health (NIMH) that involve human research participants increasingly propose collecting data from wearable devices or from cell phones. Such devices have the potential to provide information that may turn out to be very useful in creating biomarkers for groups of people who have a mental illness.

However, wearable devices and cell phones are created by a number of different manufacturers each of whom deliver analyzed data (for example about sleep quality) to consumers. In some cases, the raw data are also made available to the consumer, but the data format for either raw or derived data streams differs from manufacturer to manufacturer. This makes it difficult or impossible to link data sets coming from different devices.

Other areas of data collection have had similar issues and have found solutions to those problems. For example, in the human magnetic resonance imaging field, each of the device manufacturers collect data using different protocols and have different internal data formats from the other manufacturers.

However, that community has developed the Digital Imaging and Communications in Medicine (DICOM) data standard that allows each manufacturer to export data using the same standard. In turn, this has allowed researchers to develop analysis tools and pipelines that begin with data in DICOM format. Such standardization has been essential for data analysis in the field.

DICOM is not the only standard that is useful in the magnetic resonance space. Other standards such as the Neuroimaging Informatics Technology Initiative (NIfTI) and its derivatives have been very useful to the research community. For standards pertaining to wearable devices and cell phones, it may also be appropriate to have specialized standards in some areas as well as a larger general standard.

The overall goal of this Notice of Funding Opportunity (NOFO) is to develop standards that include data formats, data organization, device descriptions, and related information that will promote re-use and integration of data from wearable devices and cell phones. The standards and data formats can be aimed at raw data, derived data, or both.

A recent meeting held at UCLA, Digital Sensing for Mental Health on February 23 to March 2, 2023, discussed many of these issues. The specific goal of this NOFO is to develop standards and data formats that will promote re-use of data from wearable devices and cell phones. Examples of wearable devices include jewelry, activity trackers, watches, glasses.

For this NOFO, cell phones are also included. Sensors that monitor activity in rooms or other defined locations but do not have a wearable component are not responsive to this NOFO. One important issue related to data from wearable devices is the definition of what information should be considered data and what information should be considered metadata.

In many fields, header records are used to hold information about the image (for example), and there is a clear distinction between metadata and data. For wearable devices and cell phones, the difference may be less clear. For the purpose of this NOFO, any activity that makes it easier to reuse data from wearable devices and cell phones is allowable for both data as well as for metadata.

The applicant should define how to standardize both types of information in their application. Issues that will have to be addressed in proposed standards include: The need to record information about both the hardware and software used to record the data from the wearable device or cell phone. This is essential to allow the research community to deal with version changes for a single manufacturer over time.

For standards that are dealing with derived data (potentially related to sleep, stress, emotion or other phenotypes that may not be the same in all cultures), the applicant must address how cultural differences and norms will be incorporated into the proposed standard. Proposed standards may need to deal with time synchronization at very different frequencies.

In such situations, applicants will have to consider carefully how they define an event for their proposed standard. The use of data from wearable devices can raise ethical and privacy issues. Such issues should not be dealt with in the proposed standards but will be dealt with by the archive holding the data in collaboration with appropriate Institutional Review Boards.

However, the applicant can propose to organize a meeting or meetings related to these ethical issues and to make the recommendations coming from such meetings widely available to the wearable device research community. The development of standards can take many different pathways, but for this NOFO there is a particular pathway that is recommended. That pathway includes: Assembling a team to develop the standards.

This team must include researchers who are familiar with collecting data using wearable devices. Participation by relevant device manufacturers in the work of the team is also a requirement. The goal of including device manufacturers in the team is to encourage them to adopt the new standard in their devices.

Participation by end users and/or people with lived experience should be considered by the applicant. Develop a prototype standard using the expertise of the group. Applicants are encouraged to propose a specific data analysis project with real data from more than one device to ensure that the prototype standard is robust and applicable to multiple wearable devices.

Soliciting comments from the broader wearable device community and proposing a mechanism to alter the prototype standard after receiving those comments. Comments should be solicited from researchers who are developing software relevant to analyzing data from wearable devices. Soliciting comments from the end user community must also occur at this stage of the development of the standard.

Proposing a way to encourage the device manufacturers to adopt the new standard. Device manufacturers do not need to retire their existing data formats, but they should make data using the new standard available to consumers as well as researchers. Making details about the standard widely and freely available to both the research community and to relevant manufacturers.

Applicants are strongly encouraged to extend existing standards where possible. Standards that can be widely used (either in the number of different devices, manufacturers, or customers who would use devices with those standards) are strongly preferable to narrower standards. The wearable device field is changing rapidly.

Because of the speed of developments, it would not be surprising if the initial standard(s) developed under this NOFO will need to be updated. Applicants should include a plan for updating the initial standard. The timelines or triggers that would indicate a need for an updated standard should be included in the application.

The ownership of the initial standard should also be discussed in this section. Finally, members of the research community will require training in the contents of the new standard as well as how to use the standard in their research programs. Applicants should propose appropriate training activities.

Applications Not Responsive to this NOFO Applications that are focused on developing standards for anything other than derived or raw data from wearable devices or cell phones are non-responsive and will not be reviewed. Applications focused on other aspects of measuring or using data from wearable devices are non-responsive and will not be reviewed. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but need to reflect the actual needs of the proposed project.

The maximum project period is 4 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. Costs for a meeting related to ethical and privacy issues can be requested in the budget.

All instructions in the How to Apply-Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: The Research Strategy section must be divided into the following sections: Scope of the Proposed Standard.

This section must describe the devices for which a standard will be developed. A discussion of the relationship of the proposed standard to other standards would be appropriate in this section. Approach for Developing the Standard.

This section must include the types of people who will be involved in the design of the standard but must not include the names of participants. A discussion of how this team will lead to widespread adoption as well as consideration of diverse views would be appropriate in this section. Plan for Updating the Initial Standard.

This section must include the timeline or triggers for an update. This section must also include a discussion about who will own the standard. Dissemination of the Standard.

This section must include a discussion of how the standard will be made available to the research community, how the community will be trained to use the standard, and metrics to measure the use of the standard. Those metrics will likely be more useful if they use some sort of persistent identifier to track usage rather than just downloads of the standard. Ethical and Privacy Issues.

This section is not required, but if applicants are going to work in this area their plans must be presented here. Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply- Application Guide must be followed.

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply- Application Guide. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 2.

Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4.

Submission Dates and Times Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies).

Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants. gov systems check the application against many of the application instructions upon submission.

Errors must be corrected and a changed/corrected application must be submitted to Grants. gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications . Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide.

5. Intergovernmental Review (E. O.

12372) This initiative is not subject to intergovernmental review. All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.

9. 1 Selected Items of Cost. 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply Application Guide. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date.

Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide .

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII. All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form .

Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply Application Guide. See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIMH, NIH. Applications that are incomplete,non-compliant and/or nonresponsive will not be reviewed.

Requests of $500,000 or more for direct costs in any year Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the How to Apply - Application Guide .

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy Section V. Application Review Information Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will evaluate Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate criterion score. Factor 1.

Importance of the Research (Significance and Innovation) Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.

Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study. Evaluate the extent to which innovation influences the importance of undertaking the proposed research.

Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field. Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.

Evaluate whether the scope of the proposed standard is well justified. Evaluate whether the proposed standard covers a significant portion of the wearable device field. If the standard does not cover the entire wearable device field, evaluate whether that limitation is justified.

Evaluate whether the proposed standard would be able to cover any missing devices at a later date, or to link to existing standards for those devices. Factor 2. Rigor and Feasibility (Approach) Evaluate the scientific quality of the proposed work.

Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility). Evaluate the potential to produce unbiased, reproducible, robust data. Evaluate the rigor of experimental design and whether appropriate controls are in place.

Evaluate whether the sample size is sufficient and well-justified. Assess the quality of the plans for analysis, interpretation, and reporting of results. Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.

For applications involving human subjects or vertebrate animals, also evaluate: the rigor of the intervention or study manipulation (if applicable to the study design). whether outcome variables are justified. whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.

whether the sample is appropriate and sufficiently diverse to address the proposed question(s). For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research.

Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science. Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work.

For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances. For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain an appropriately diverse population of participants.

Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, race, ethnicity, and sex. For clinical trial applications, evaluate whether the study timeline and milestones are feasible.