Data Coordinating Center for Multi-Site Clinical Trials of Mind and Body Interventions (U24) is a grant from the National Institutes of Health (NCCIH) that funds a collaborative data coordinating center (DCC) supporting NCCIH-funded multi-site investigator-initiated clinical trials of mind and body interventions.

The DCC works in partnership with a companion Clinical Coordinating Center (CCC) to manage and coordinate trial data across sites. This U24 Resource-Related Research Project uses a cooperative agreement mechanism. Eligible applicants are domestic organizations; the DCC application must be submitted simultaneously with a companion CCC application.

Funding varies and the deadline is 14 July 2026.

PAR-24-276: Data Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 Clinical Trial Required) 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. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Center for Complementary and Integrative Health ( NCCIH ) Funding Opportunity Title Data Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 Clinical Trial Required) U24 Resource-Related Research Projects – Cooperative Agreements Notices of Special Interest associated with this funding opportunity 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 4, 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 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II See Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) Funding Opportunity Purpose This notice of funding opportunity (NOFO), utilizing the U24 grant funding mechanism, encourages applications for a collaborating data coordinating center (DCC) application that accompanies an investigator-initiated multi-site clinical trial (Phase III and beyond) application submitted under companion PAR-24-275 .

The DCC application must be specific to the companion clinical coordinating center (CCC) application. The objective of the DCC application is to propose a comprehensive plan that provides overall project coordination, and administrative, data management, and biostatistical support for the proposed clinical trial. Both a DCC application and a corresponding CCC application need to be submitted simultaneously for consideration by NCCIH.

Trials for which this NOFO applies must be relevant to the research mission of NCCIH and considered a high priority by the Center. For additional information about the mission, strategic vision, and research priorities of NCCIH, applicants are encouraged to consult the NCCIH website ( https://www. nccih.

nih. gov ). Applicants are encouraged to contact the appropriate Scientific/Research Contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO.

Open Date (Earliest Submission Date) 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 How to Apply - Application Guide and the NOFO) is required and strictly enforced.

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

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. 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 The National Center for Complementary and Integrative Health (NCCIH) is committed to the rigorous investigation of promising complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions).

These mind and body interventions are widely used by the public, and they are increasingly recognized as a nonpharmacologic approaches to symptom management (e.g., chronic pain, mild depression, anxiety). These approaches can be used by individuals to help prevent, treat, or self-manage various conditions, and they can be complementary to conventional health care.

There is a need for research to evaluate mind and body and/or multicomponent approaches as they are used and delivered to determine whether they are safe and efficacious or effective for given conditions or disorders.

For clinical trials to address this need, they must be well designed and test hypotheses that will guide decisions about the inclusion of these interventions or approaches into the delivery of health care for a given condition or disorder. To accomplish this goal, multi-site clinical trials are needed to determine the efficacy or effectiveness in a fully powered clinical trial.

NCCIH utilizes the U24 funding mechanism to support the independent Data Coordinating Center (DCC)) and the UG3/UH3 funding mechanism to support the companion Clinical Coordinating Center (CCC)) research project for the trial.

Research Objectives of the Clinical Coordinating Center (CCC; UG3/UH3) and the Data Coordinating Center (DCC; U24) for Multi-site Investigator-Initiated Clinical Trials of Mind and Body Interventions NCCIH requires companion applications to support a CCC and DCC for multi-site investigator-initiated clinical trials to test the efficacy or effectiveness of mind and body or multi-component interventions.

The CCC and DCC will need to collaborate closely to develop the study protocol and select the most rigorous trial design. The CCC has clinical content expertise to study the proposed intervention and study population and is responsible for implementing the proposed multi-site clinical trial.

The DCC has expertise in clinical trial design and conduct and is responsible for overall project coordination and administrative, data management, and biostatistical support for the proposed clinical trial, including sample size calculations and the data analysis plan.

NCCIH requires that the DCC be independent from the CCC (e.g., not include overlapping personnel) in order to provide for central coordination of study activities across multiple sites while ensuring the integrity of the intervention delivery, data collection, and study blinding.

Research Objectives for the DCC This notice of funding opportunity (NOFO) supports applications for a DCC to support a corresponding investigator-initiated multi-site efficacy, effectiveness, or pragmatic clinical trial (Phase III and beyond). The DCC is integral to the proficient operation of a clinical trial. The DCC contributes to the study design; ensures appropriate adverse event monitoring and reporting.

The DCC also manages data, masks intervention assignment, and manages the random assignment of research participants in the research arms of the study; prepares interim data reports for the Data and Safety Monitoring Board (DSMB); conducts statistical analyzes; and helps with the dissemination of the results.

Clinical trials require the recruitment of research participants, so it is of foremost importance to ensure their safety as well the inclusion of individuals of various sexes, races, ethnicities, and ages (including children and older adults) insufficient numbers to conduct meaningful analysis among subgroups.

An independent DCC is critical to the integrity of the data collection and intervention delivery because of the need for central coordination of these activities in complex multi-site clinical trials. For this NOFO, multi-site clinical trials must enroll research participants from at least three geographically distinct recruitment sites.

Two sites will be permitted if there is a strong justification for how fewer sites can still achieve generalizability and meet the NIH inclusion requirements for a Phase III clinical trial. Multiple sites are necessary in efficacy trials to enhance recruitment efforts that will increase generalizability of findings with a broad range of research participant representation.

Trials supported under this NOFO are expected to contribute to the evidence base for important research and health matters of relevance to the mission of NCCIH and meet the definition of an NIH clinical trial (see NOT-OD-15-015 [ https://grants. nih. gov/grants/guide/notice-files/NOT-OD-15-015.

html ]). For additional information about the mission, strategic vision, and research priorities of NCCIH, applicants are encouraged to consult the NCCIH website ( https://www. nccih.

nih. gov ). In addition to scientific relevance and excellence, these clinical trials are expected to be conducted with a high degree of efficiency, with streamlined administrative procedures wherever possible.

Proposed clinical trials may utilize a design anywhere along the continuum between explanatory and pragmatic. For this NOFO, pragmatic trials are considered those that test an intervention under the usual clinical conditions in which it will be applied, while explanatory trials do so under more idealized circumstances. The trial design should be appropriate for the study question.

This DCC NOFO runs in parallel with a companion NOFO ( PAR-24-275 ) that encourages applications for a collaborating CCC. Both a DCC application and a collaborating CCC application must be submitted on the same due date for consideration by NCCIH. DCC applications submitted without a collaborative CCC (UG3/UH3) will be deemed incomplete and will not be reviewed.

This NOFO will utilize a collaborative resources-related cooperative agreement (U24) funding mechanism and will be milestone-driven and performance-based to achieve completion of the study on time and on budget. The first year of the DCC will correspond with the UG3 planning phase of the collaborative CCC application to PAR-24-275 .

During the first year, the DCC will support the development of case report forms, trial database, data quality assurance plan, study partnerships; informed consent(s); institutional review board (IRB) and DSMB approval of the trial protocol; manual of operations, project management plans, and other resources necessary to the performance of the actual clinical trial with the support of the CCC and DCC.

DCC Applications are expected to propose how they will provide data coordination for the clinical trial in a project management plan that includes consideration of the feasibility of trial launch, conduct, and completion of the trial on time and on budget.

As appropriate, the DCC will need to work with the CCC to obtain all necessary regulatory approvals as well as provision of any necessary natural products, intervention providers, devices, or other necessary resources for the successful launch and execution of the proposed clinical trial. The proposed clinical trial isexpected to be able to begin enrollment at the start of the second year of the CCC and DCC awards.

The second-year award and additional out-years of the DCC are contingent on the successful completion of milestones under the first year of both the CCC and DCC. The decision to proceed beyond the first year of the DCC award will be made after an NCCIH administrative review of the progress made by both the DCC and the CCC at the end of their first year.

Continued support for both the DCC and CCC will be contingent on the extent to which agreed-upon milestones have been met in the first year and on the availability of funds and NCCIH scientific priorities. If agreed-upon milestones are not met in either the CCC or DCC, NCCIH will work with the DCC and CCC to conduct an early and orderly phase-out of the project. The use of milestones is a key characteristic of this NOFO.

A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity. Applications must be driven by milestones to be reached for each year of the DCC's support of the clinical trial. Milestones are to be objective and performance-based goals to achieve completion of the trial on time and on budget (see example milestones at https://www.

nccih. nih. gov/grants/toolbox/toolbox-policy-and-guidance ).

The DCC application should include key milestones that need to be met during the first year of the award to allow for successful launch of the clinical trial in the second year of the CCC and DCC. This NOFO will support applications that utilize a series of milestones that synchronize activities between the DCC and the collaborating CCC activities needed to support the successful completion of the clinical trial.

NCCIH staff, in collaboration with the awardee, will closely monitor progress, milestones, accrual, and human subject safety at all stages of the project. NCCIH policies regarding milestones and relevant clinical research/studies are described in the NCCIH Study Accrual and Retention for Human Subjects Research Policy ( https://www. nccih.

nih. gov/grants/policies/nccih-policy-study-accrual-and-retention-for-human-subject-research ), NCCIH Clinical Terms of Award for Human Subjects Research ( https://www. nccih.

nih. gov/research/nccih-clinical-terms-of-award-for-human-subjects-research ), and NCCIH Policy on Data and Safety Monitoring ( https://nccih. nih.

gov/grants/policies/data-safety-monitoring ). Clinical trials supported by this NOFO must also adhere to the NIH Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials ( https://grants. nih.

gov/grants/guide/notice-files/NOT-OD-16-148. html ). Specific Areas of Research Interest Prior to submitting to this NOFO, all applicants are strongly encouraged to consult with the Scientific/Research Contacts for the area of science of the CCC application for which a resource-related research grant is being submitted.

Early contact (at least 12 weeks prior to submission) is encouraged. This period of time provides an opportunity for NCCIH staff to discuss the scope and goals and to provide information and guidance to the applicants. See Section VIII.

Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II.

Award Information Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.

2 for additional information about the substantial involvement for this NOFO. 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.

Required: Only accepting applications that propose clinical trial(s). 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 combined budgets of the CCC and DCC will be used to determine whether the policy regarding direct costs of $500,000 or more in any year will be applied ( https://www. nccih.

nih. gov/grants/policies/nccih-policy-applications-for-large-budget-clinical-trials-over-500000-in-direct-costs-in-any-year ). The scope of the proposed project should determine the requested project award period.

The period of award for the U24 phase is expected to be 5 years. Up to 7 years may be requested if strongly justified. 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) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not 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 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 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 ). This NOFO only accepts applications that are part of a collaborative set of multiple applications. A set must contain one application to this NOFO and one application to PAR-24-275 .

Applications with Foreign components are encouraged to read the NCCIH International Health Research page . Foreign components can include foreign collaborators or consultants but should not include foreign sites outside of the United States or Canada, according to NCCIH’s policy. 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 How to Apply - 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. To allow NIH to identify a group of applications as a related set of collaborative applications, the titles for each application in the set must have the following format: a "1/N" indicator + Identical Title (e.g., "1/2" where the 1/2 means this is application 1 for the CCC of the set. The DCC application will be labeled 2/2.)

Titles may not exceed 200 characters in length, including the tag, e.g., 1/2 at the beginning of the title. A cover letter is required for each application submitted in response to this collaborative NOFO. The cover letter should include names of the PD/Pl for both the collaborating CCC and DCC applications; the title of the projects (which should be the same in both CCC and DCC applications); and the names of applicant institutions.

If applicable, the letter should indicate the name of the NCCIH program officer with whom the project has been discussed. If the direct costs of the combined DCC and CCC budgets equal or exceed $500,000 in any given year, a copy of the NCCIH permission to apply letter must be attached ( https://www. nccih.

nih. gov/grants/policies/nccih-policy-applications-for-large-budget-clinical-trials-over-500000-in-direct-costs-in-any-year ). SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed.

Describe the facilities and resources available for the DCC infrastructure to support and enable the conduct of the research proposed in the multi-site clinical trial. SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed. A Project Management Plan must be provided as an "other attachment" called "DCC Project Management Plan.

pdf' and must not exceed three pages. The Project Management Plan should describe the evidence-based strategy that will be used throughout the project by the DCC to ensure that the unique goals of the clinical trial are met within the constraints of time and funding permitted under this NOFO.

Project management planning should directly support the needs of scientific study leadership to identify barriers, make timely responses, and optimize the allocation of limited resources to meet predefined study objectives. The project management plan should describe how the planning team will work together and identify control points and processes that are critical for scientific and fiscal performance.

This will include a description of the organizational strategy that defines internal control points and business roles. A description of the methodology, standards, and processes governing resource management; study deployment; operations/execution; and study closure should be included.

The management plan should also describe how the team, in collaboration with the CCC, will proactively evaluate and prioritize issues that could jeopardize study goals and how corrective responses will be developed to resolve fiscal and logistical issues (risk planning) in a timely manner. Describe processes required for orderly project closure.

In summary, the project management plan should provide sufficient detail that demonstrates the ability to achieve the goals of the clinical trial on-budget and on-time. The project management plan should include risk management or contingency plans.

The plan should address how enrollment data will be shared on a regular basis with NCCIH, including any proposed use of electronic enrollment data reports sent directly to NCCIH's accrual monitoring system. 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.

All costs requested and all changes in budgets after the first year should be clearly identified and justified. The DCC budget must be synchronized with the CCC budget. If parts of the trial costs are to be provided by sources other than NCCIH, these contributions must be presented in detail in the budget justification.

Third Party support of the proposed research activity (if approved) will be incorporated as a specific term and condition in the Notice of Award. If the Third Party support ceases and the trial is no longer tenable without the Third Party support, a close-out plan may be requested.

Applicants are reminded that although Cost Share is not required, if these types of costs are included in the research application and peer reviewed, it is expected that these costs will not be covered by NCCIH. The application for the DCC must include only the personnel and corresponding biographical sketches for the key personnel for that application.

All Key Personnel involved in the data management, analysis, and quality control of the clinical trial must provide an NIH Biosketch regardless of whether they are budgeted. The PD/PI (or Multi-PDs/Pls) for the companion CCC cannot be listed as key personnel in the DCC application.

The DCC should include in their budget all costs associated with preparation of materials for DSMB meetings and travel for key personnel to all in-person DSMB meetings. This includes the costs for preparing reports for the DSMB.

Budgets should include costs for unmasked biostatistician(s) for generating the randomization scheme and preparing unmasked DSMB reports in addition to the study’s masked biostatistician who will conduct study analyses at the end of the trial and prepare open reports for the DSMB. An independent DSMB will be established to monitor data and oversee participant safety in the clinical trial.

NCCIH and the investigator team will determine if the DSMB will be appointed and established by NCCIH or by the investigator team, in accordance with NIH and NCCIH policies.

Applicants should provide areas of expertise of DSMB members but not propose DSMB members in the application, or even inquire about the interest of possible DSMB members because anyone so contacted would not be eligible to serve as a member of the peer reviewer committee that will evaluate the applications for scientific merit.

The DCC should budget for the attendance of their key personnel to all in-person steering committee meetings in collaboration with the CCC. Include budget support for publication, data sharing, and dissemination of results. 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: Note: Discuss the following without duplicating information collected in the Public Health Service (PHS) Human Subjects and Clinical Trials Information Form.

The Research Strategy should be organized in a manner that will facilitate peer review. The body of the application must present a discussion of the approach to coordination and administration, data management, biostatistical support, and data analysis.

The following criteria must be addressed: Significance: Explain why the chosen study design is optimal to answer the scientific question posed for the trial described in the CCC application. Justify the appropriateness of the study sample size, power, and effect size for the trial. Innovation: Describe plans to employ unique or novel methodologies that will enhance the clinical trial design, management, or methods of data analysis.

Describe innovation of planned approaches to project coordination and logistical support. Describe plans for utilization of current best practices to improve the knowledge and/or skills of key personnel of the multi-site clinical trial.

Approach: Describe the planned approaches to study coordination, data management (including data security procedures), data monitoring and reporting, and biostatistical support and include a description of how these approaches will contribute to the success of the trial.

Describe plans for coordination of the project, study design, and data management and quality control, and provide details of the elements of the statistical analysis and milestone plans. Coordination: Describe plans for how the multi-site clinical trial will be coordinated, including plans for providing administrative and operational support.

Describe how the DCC will interact and collaborate with the CCC and individual sites, including transmission of data in an accurate and timely fashion. Study Design: Describe the proposed experimental approach, including a discussion of the clinical trial design and the rationale for the particular design chosen (pragmatic, explanatory, cluster-randomized, adaptive, etc.). Provide details of the randomization scheme, if applicable.

Data Management and Quality Control: Describe the approach to data management, including data management systems, methods of data entry, case report forms, methods for assessing the quality and consistency of the intervention(s) and data collection, policies and methods for ensuring blinding of study results, and data confidentiality and subject privacy.

Letters of support from institutions with a key personnel in the study must be provided. Letters of support from department chairs whose support are necessary for the functions of the DCC should be provided. Applicants are also encouraged to include documentation of the commitment of any subcontractors and consultants, as well as service agreements for personnel or facilities.

Letters of commitment must be co-signed by the business official of the collaborating organization. For renewal applications, a summary of progress made during the initial funding period must be included. Resource Sharing Plan