Heart Failure Clinical Research Network (U10)

Heart Failure Clinical Research Network (U10) is sponsored by National Institutes of Health (NIH). This solicitation requests new applications for participation in the Heart Failure Clinical Research Network as the combined Data Coordinating Center/Clinical Coordinating Center (CC).

Expired RFA-HL-12-002: Heart Failure Clinical Research Network Coordinating Center (U10) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Participating Organizations Institute of Health (NIH) ( http://www.

nih. gov ) Components of Participating Organizations Heart, Lung, and Blood Institute (NHLBI) ( http://www. nhlbi.

nih. gov ) Failure Clinical Research Network Coordinating Center (U10) Request For Applications (RFA) Number: RFA-HL-12-002 Catalog of Federal Domestic Assistance Intent Receipt Date: November 1, 2010 Application Receipt Date: December 1, 2010 Anticipated Start Date: January 1, 2012 Additional Information To Be Available Date (Url Activation Date): Not Applicable Expiration Date: December 2, Purpose .

The purpose of this solicitation is to request new applications for participation in continuationl of the Heart Failure Clinical Research Network as the combined Data Coordinating Center/Clinical Coordinating Center (CC). A separate solicitation ( RFA-HL-12-001 ) seeks applications for the Regional Clinical Centers (RCCs).

The original Network was established to provide a mechanism to expedite clinical research that evaluates strategies to diagnose, manage and treat all forms of heart failure (HF). The renewal program will continue to provide support to develop, coordinate, and conduct multiple collaborative randomized clinical trials (RCTs) to improve HF outcomes.

The focus is on small to intermediate-sized concurrent RCTs that can be completed within 2-5 years and the program is not designed to fund large, Phase III definitive studies. Proposed studies should provide clinically relevant pathophysiologic information and move the field of HF treatment forward.

The Coordinating Center of the Network leads and manages all aspects of these RCTs, including those of a Data Coordinating Center, as well as those of a Clinical Coordinating Center. The two functions (Data Coordination and Clinical Coordination) should be performed at the same institution. A Multiple PI structure to facilitate implementation of all CC functions is highly encouraged.

The solicitation is open to new and currently participating centers. Mechanism of Support. This FOA will utilize Anticipated Number of Awards.

A total of $33. 6 million over 7 years will be available to the CC. Of this, a total of $16.

8 million is available for CC functions. Additionally, the CC will administer $16. 8M in Protocol Funds available through subcontracts to the participating Regional Clinical Centers and any necessary Core Laboratories.

A single award to a single institution will be Budget and Project Period. The Direct Costs for all CC operations cannot exceed $1. 55 million per year.

The total project period for an application submitted in response to this funding opportunity may not exceed seven years. Applicants should request the award of the Protocol Funds in the CC application. These Protocol Funds do not require a detailed budget as they will be distributed based on the requirements of the protocols selected for implementation after award of the RCCs and approval by the Protocol Review Committee (PRC).

Application Research Strategy Length: The U10 Research Strategy section may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. See Table of Page Institutions/Organizations. Institutions/organizations listed in Section III, 1.

A. are eligible to apply. Directors/Principal Investigators (PDs/PIs).

I ndividuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. of PDs/PIs.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application. Resubmissions. Resubmission a pp lications are not permitted applications are not permitted in response to this FOA.

Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates .

Application Materials. See Section IV. 1 for application Impaired.

Telecomm unications for the hearing impaired are available at: TTY: (301) 451-59 3 6 Part I Overview Information Part II Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information 1.

Mechanism(s) of Support 2. Cost Sharing or Matching 3. Other - Special Eligibility Criteria Section IV.

Application and 1. Address to Request Application Information 2. Content and Form of Application Submission 3.

Submission Dates and Times B. Sending an Application to C. Application Processing D.

Application Assignment 4. Intergovernmental Review 6. Other Submission Requirements Section V.

Application Review 2. Review and Selection Process 3. Anticipated Announcement and Award Dates Section VI.

Award Administration 2. Administrative and National Policy Requirements Terms and Conditions of Award Principal Investigator Rights and Responsibilities Collaborative Responsibilities Section VII. Agency Contact(s) 1.

Scientific/Research Contact(s) 2. Peer Review Contact(s) 3. Financial/ Grants Management Contact(s) Section VIII.

Other Information - Required Federal Citations - Full Text of Announcement Section I. Funding Opportunity Description Nature of the Research Opportunity: The purpose of this solicitation is to request new applications for the combined Data Coordinating Center/Clinical Coordinating Center (CC) which will be part of the renewal of the Heart Failure Clinical Research Network.

A separate solicitation (RFA HL-12-001 ) seeks applications for the Regional Clinical Centers (RCCs). The original Network was established to provide a mechanism to expedite clinical research that evaluates strategies to diagnose, manage and treat all forms of heart failure (HF).

The renewal program will continue to provide support to develop, coordinate, and conduct multiple, collaborative, proof of concept clinical trials to improve HF outcomes. The solicitation is structured to support concurrent, small to intermediate-sized randomized clinical trials (RCTs) that can be completed within 2-5 years and is not designed to fund large, Phase III definitive studies.

The CC of the Network leads and manages all aspects of the conduct of multicenter RCTs. The CC will manage site contracts, training, recruitment monitoring, regulatory compliance, patient safety, protocol development, conflict of interest and other policy development, manuals of operations, committee management, and additional clinical expertise in support of RCCs.

The CC includes a Data Coordinating Center function with expertise in statistical planning in support of protocol development, data collection, maintenance of data quality and integrity. The Data Coordinating Center component will also prepare reports to the Data and Safety Monitoring Board, coordinate site visits, and perform statistical analyses.

The two functions (data coordination and clinical coordination), should be performed at the same institution. A Multiple PI structure to facilitate implementation of all CC functions is highly encouraged.

The solicitation is open to new and currently Heart Failure (HF) is a common syndrome and, in contrast to other cardiovascular diseases, is responsible for an increasing number of hospitalizations and deaths each year in the U.S. HF is expected to be an even more important cause of morbidity with the aging of the U.S. population.

Although survival after the onset of heart failure has improved, modern therapies are not curative, and the syndrome is progressive in many patients despite optimal modern therapy. The health care costs related to HF have been estimated to be as high as $35 billion annually.

In response to this clinical problem and with the guidance of two Working Groups, the National Heart, Lung, and Blood Institute, issued RFA- HL-05-003 to form the Heart Failure Clinical Research Network. A network structure allows for efficiency in conducting multiple concurrent trials and enables a team of investigators to plan and execute serial trials based on earlier results.

The Network has been successful in conducting up to three concurrent randomized clinical trials to advance the treatment of patients with acute and chronic heart failure. One clinical trial has been completed, two additional trials are expected to be completed in the initial funding period and the Network has received approval to begin two additional trials in the current project.

Due to the success of the program, the NHLBI plans to continue the Network for an additional seven years, through this and the companion RFA HL-12-001 for Regional Clinical Centers. Knowledge to be Achieved Through Research Supported: The primary goal of the Network is to conduct multiple Network-wide randomized clinical trials to evaluate treatments and strategies for the management of acute and chronic HF.

The scientific agenda will be developed through collaborative decision making of the Steering Committee, consisting of the program’s CC and RCC PIs, the NHLBI-appointed Study Chair, and NHLBI representatives. All protocols must be approved by both the NHLBI-appointed Protocol Review Committee and Data and Safety Monitoring Board.

During the first funding period, the Network’s agenda included addressing practical questions in the day-to-day management of HF, such as the optimal way of administering diuretics during acute decompensation without worsening renal function and testing new therapies for HF with preserved systolic function.

The Network renewal will continue its tradition of answering practical clinical questions as well as potentially testing new therapies and hypotheses formulated from the first round of studies or other advances in the field of HF research.

The primary goal of the Network is to improve the treatment of HF by rigorous testing, through randomized clinical trials, interventions that aid in diagnosis, therapy, management of HF and prevention of the syndrome or its associated morbidity.

Secondary objectives of the Network are to: Establish a knowledge base that will improve therapeutic decision making by testing approaches to manage acute and chronic HF Develop methods to predict individual responses to Evaluate quality of life and cost-effectiveness of HF Establish collaborations between Regional Clinical Centers and the practice community Train physicians in HF clinical investigations Disseminate findings to the medical community.

Types of research and experimental approaches The emphasis will be on early phase small to intermediate-sized randomized clinical trials that help identify optimal diagnosis, evaluation, and therapy to improve ventricular function and studies should provide clinically relevant pathophysiologic information and move the field of HF treatment forward.

Trials may involve investigational drugs or other interventions or new strategies for currently used interventions. Proposed trials should make use of the Network model. Proposed interventions to be tested should be implementable at most, if not all, Network RCCs and/or satellites.

For acute HF, endpoints can be measured over shorter durations. For both acute and chronic HF, meaningful composite endpoints can be chosen that accommodate trials with sample sizes of fewer than a thousand patients. The Network is expected to be able to concurrently successfully perform three or four trials and should be able to complete two or three waves of trials in the seven-year period.

Examples of Research Topics: Potential research protocols might include, but are not limited to, RCTs that: of new drugs or other interventions on ventricular function and clinical established drugs or interventions in HF treatment therapies or improved diagnostic tools for HF with preserved ejection methods for renal protection during Acute Decompensated HF (ADHF) of emergency room interventions on the treatment of ADHF treat pulmonary hypertension associated with HF interactions between pulmonary and sleep disorders and HF Trials that involve techniques, procedures, or biologic agents that cannot be disseminated for implementation in a Network model will be considered non-responsive.

Large Phase III RCTs, epidemiologic or other observational studies, and protocols based on behavioral and lifestyle intervention will be considered non-responsive to this The Heart Failure Clinical Research Network will be funded as a cooperative agreement and consist of up to nine Regional Clinical Centers, a single combined Coordinating Center performing Data and Clinical Coordination, an NHLBI-appointed Network Study Chair and the NHLBI.

Applications for Regional Clinical Centers are solicited through governing body of the HF Network and is expected to meet by teleconference on a bi-monthly basis. Committee members will include the Study Chair, PIs of CC and the Regional Clinical Centers, and NHLBI program staff.

The Study Chair will be appointed by the NHLBI and will be responsible for oversight of the scientific agenda and progress of the Network in achieving its scientific goals.

The responsibilities of the SC will include, but not be limited to: (1) ensuring compliance with Network policies and procedures, (2) identifying and prioritizing topics for investigation, (3) evaluating and developing protocols proposed by RCCs or others outside the Network for Network implementation, (4) ensuring that studies are appropriately carried out; (5) ensuring that data are appropriately analyzed and interpreted, and (6) ensuring that study results are published in a timely fashion.

Other governance committees may be continued or developed such as the Executive Committee, Publications Committee, and Ancillary Studies Committee. The separate charges for these committees will be maintained in a continually updated Manual of Operations for Network activities. Protocol Review Committee An independent PRC will be appointed by the NHLBI and will meet as needed to review protocols.

It will consist of a chairperson and scientists with expertise in HF research, clinical trial design, biostatistics, and other areas of expertise as needed. The PRC will evaluate protocols proposed by the SC based on the following criteria: (1) the scientific merit of the experimental design and approach, (2) the feasibility, and (3) the appropriateness of the protocol for the Network and the consistency with the mission of the NHLBI.

All new study protocols performed by the Network must be approved by the PRC before referral to the DSMB. Minor protocol amendments, low burden ancillary studies or secondary analyses of approved trials may be directly referred to the Data and Safety Monitoring Board for consideration. Data and Safety Monitoring DSMB in accordance with established policies to ensure data quality and participant safety.

All Network protocols must be approved and monitored by the DSMB, generally after their approval by the PRC (except in the case of minor protocol amendments or low burden ancillary studies or analyses of approved trials). The DSMB will be responsible for providing independent advice to the NHLBI regarding the progress of each trial and the appropriateness of continuing each study.

The DSMB will meet approximately every 6 to 12 months with interim meetings or calls as necessary. See Section VIII, Other Information - Required Federal Citations , for policies related to this announcement. opportunity will use the U10 award mechanism(s).

Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project. FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.

nih. gov/grants/funding/phs398/phs398. html ).

will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2.

Administrative Requirements , "Cooperative Agreement Terms and Conditions of Award." total amount of funding that will be available through this announcement is up to $33. 6 million over 7 years.

this, a total of $16. 8 million is available for CC functions required to administer the development, implementation, conduct, and analyses of multiple, concurrent randomized clinical trials. Additionally, the CC will administer $16.

8 million in Protocol Funds available through subcontracts to the participating Regional Clinical Centers, the satellite sites and any Core Laboratories deemed necessary for the experimental protocols. Distribution of Protocol Funds will be made to participating RCCs on a per subject enrolled basis at a rate approved by the NHLBI Office of Grants Management.

The rate will be determined on the basis of the complexity of the trial design, using input from the Network Study Chair and Steering Committee and based in part on funding levels used in the first project period of the Heart Failure Network. The funding structure will use two rates of per capita payment, with the higher level awarded after a specified number of subjects have been enrolled in a trial from a given site.

Distribution of Protocol Funds to Core Laboratories will be made with the approval of the NHLBI Office of Grants Direct Costs for the support of CC functions should not exceed $1. 55 T he total project period for an application submitted in response to this funding opportunity may not exceed seven years. A single award to a single institution will be made.

administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004 . grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in III. Eligibility Information 1.

A.

Eligible Institutions following organizations/institutions are eligible to apply: Controlled Institutions of Higher Education Institutions of Higher Education Black Colleges and Universities (HBCUs) Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions with 501(c)(3) IRS Status (Other than Institutions of Higher Education) without 501(c)(3) IRS Status (Other than Institutions of Higher Education) Organizations (Other than Small Businesses) American Tribal Governments (Federally Recognized) American Tribally Designated Organizations Housing Authorities/Indian Housing Authorities U.S. Territory or Possession American Tribal Governments (Other than Federally Recognized) Agencies of the Federal Government or Community-based Organizations.

individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH program support.

than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants. nih.

gov/grants/multi_pi . All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://grants. nih.

gov/grants/ElectronicReceipt/preparing. htm for instructions). multiple PD/PI model is highly encouraged, to reflect the separate data coordination and clinical coordination functions performed at the institution.

If a multiple PD/PI strategy is used then the guidelines for submissions of applications with multiple PD/PI must be used. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants. nih.

gov/grants/multi_pi . Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.

Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.

nih. gov/grants/multi_pi . 2.

Cost Sharing or Matching program does not require cost sharing as defined in the current NIH Grants Policy Statement . 3. Other-Special Eligibility Criteria Applications.

Applicants may not submit more than one Resubmissions. Resubmission applications are not permitted in response to this FOA. Renewals.

Renewal applications are not permitted in IV. Application and Submission Information Request Application Information application instructions are available at http://grants. nih.

gov/grants/funding/phs398/phs398. html in an interactive format. Applicants must use the currently approved version of the PHS 398.

For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected] . Telecommunications for the hearing impaired: TTY 2. Content and Form of Application Submission Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide ( http://grants.

nih. gov/grants/funding/phs398/phs398. html ).

Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www. dnb.

com/us/ . The D&B number should be entered on line 11 of the face page of the PHS 398 number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form, and the YES box must be checked. Applications with Multiple PDs/PIs proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs.

NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period.

The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.

” The contact PD/PI must be from the applicant organization if PD/PIs are from more All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

PD/PI Leadership Plan : For applications designating multiple PDs/PIs, the section of the Research Plan entitled “Multiple PD/PI Leadership Plan”, must be included. A rationale for choosing a multiple PD/PI approach should be described.

The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award. is available in the PHS 398 grant application instructions .

Submission Dates and Times received on or before the receipt date described below ( Section IV. 3. A ).

Submission times N/A. 3. A.

Receipt, Review and Anticipated Start Dates Application Receipt Date: December 1, 2010 Peer Review Date(s): June- July 2011 Council Review Date: October 2011 Earliest Anticipated Start letter of intent should be sent to: Director, Office of Scientific Review National Heart, Lung, and Blood Institute National Institutes of Health 6701 Rockledge Drive, Room 7214 Bethesda, MD 20817 (express/courier service) Telephone: (301) 435-0270 prepared using the forms found in the PHS 398 instructions for preparing a research grant application.

Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 (U.S. Postal Service Express Bethesda, MD 20817 (for express/courier service; deliveries of applications are no longer permitted (see http://grants. nih.

gov/grants/guide/notice-files/NOT-OD-03-040. html ).

the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Director, Office of Scientific Review National Heart, Lung, and Blood Institute National Institutes of Health 6701 Rockledge Drive, Room 7214 Bethesda, MD 20817 (express/courier service) Telephone: (301) 435-0270 Applications must be received on or before the application receipt date described above ( Section IV. 3.

A. ). If an application is received after that date, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed. accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application.

However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application.

That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons. era.

nih. gov/commons/ . 4.

Intergovernmental Review This initiative is not subject to intergovernmental are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Pre-award costs are allowable.

A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: (1) are necessary to conduct the project, and (2) would be allowable under the grant, if awarded, without NIH prior approval.

If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred.

NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants. nih. gov/grants/policy/nihgps_2003/NIHGPS_Part6.

htm ) 6. Other Submission Requirements Cooperative Agreement. Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.

2. A "Award Administration The successful Coordinating Center (CC) application will be from a single institution which includes expertise in the functions typically conducted by a Data Coordinating Center (DCC) and by a Clinical Coordinating Center (CCC). Separate expert leadership is highly encouraged for these functions.

The scientific and performance requirements for these functions are delineated separately below as an example. Other divisions of duties that preserve the distinction between study conduct and data integrity are acceptable.

In general, the application should demonstrate expertise in statistical study design, protocol development, data collection, quality control, and management of data integrity and analyses; as well as in the clinical, regulatory, contractual, and logistic management required in the conduct of multiple concurrent studies performed across a Network of participating RCCs and occasionally using additional satellites recruited ad hoc for specific studies.

Scientific and Performance Requirements for the DCC: The DCC will provide expert statistical leadership for the HF Network, will maintain responsibility for data collection and data integrity, will propose and conduct appropriate study analyses, will serve as the repository for data collected, and is responsible for compliance with data sharing and other related policies.

The responsibilities of the DCC will include, but will not be limited to, the following: (1) providing statistical leadership, advice and expertise during protocol development and study implementation; (2) developing data collection and data management systems (electronic data capture systems are preferred); (3) monitoring the quality and quantity of data received from the RCCs, satellite sites and core labs; (4) preparing data reports for the DSMB, PRC, NHLBI, Steering Committee, and RCCs; (5) providing expert analyses using best-suited statistical concepts; (6) preparing abstracts and repository for the Network, (8) complying with NHLBI data sharing and related policies, and (9) providing plans for close-out or transfer of data if required at the end of the project period delineated in this announcement.

The skill requirements for the DCC include, but are not limited to, the following: experience as a coordinating center in multicenter heart failure trials; (2) expertise in clinical trial design, biostatistics, enabling technologies, data management and multicenter coordination; (3) expert ability to design protocols and utilize data collection systems, including secure transmission via the internet; (4) training and monitoring of data collection activities for multiple North American clinical sites; and (5) prior successful experience in team research to facilitate the Network model in all design, data collection, and analysis functions.

applicants should include specific examples of experience as a DCC and the applicant’s ability to provide statistical leadership to multicenter trials and networks. Applications should include any available assessment of the CC’s ability to support a large, multicenter clinical research network or large, multicenter randomized clinical trials (RCTs) from stakeholders including recruitment sites and sponsors.

In addition, the investigators should provide descriptions of innovative trial designs and statistical methods to facilitate the efficient conduct of smaller, multicenter clinical trials. Examples might include novel endpoints and creative study designs to maximize information yielded from smaller studies.

In addition, the investigators must provide a detailed description of how the DCC will interface The combined application for the separate CCC and DCC from the same institution discussing the scientific and performance requirements must follow the instructions in the PHS 398 application form, http://grants. nih. gov/grants/forms.

htm , and should not exceed 12 pages total . Scientific and Performance Requirements for the CCC: leadership on all research operational issues for the HF Network. The primary responsibilities of the CCC will be to coordinate, administer, and support clinical research activities.

will include, but will not be limited to: (1) providing clinical and scientific leadership, advice and expertise to sites during all phases of trial development and conduct; (2) providing administrative support for the NHLBI-appointed Network Study Chair, scientific leadership, and committees; (3) organizing scientific and administrative meetings; (4) developing study materials, including manuals of operations; (5) procuring and overseeing drug manufacturing, preparation, and distribution; (6) coordinating activities with core laboratories; (7) managing and distributing all protocol funds and preparing a quarterly itemized fiscal report for the NHLBI; (8) training, certifying, and supervising all sites, including conducting site monitoring visits to RCCs and their satellites, as well as to satellite sites recruited for involvement in particular trials; (9) managing site contracts and assisting sites with submissions to IRBs; (10) preparing protocols