NIDDK will support investigator-initiated, multi-center clinical studies exclusively through a two part grant process: (1) an implementation planning (U34) grant followed by (2) a cooperative agreement (U01) to conduct the study.
Multi-Center Clinical Study Implementation Planning (U34) Grant
Beginning with the March 19, 2008 application receipt date, NIDDK will support implementation planning (U34) grants for multi-center clinical studies. These grants are intended to support all administrative study group activities that are required in order to begin recruitment of subjects. These activities include, but are not limited to: establishing the research team, developing the tools for data management and oversight of the research, defining the recruitment strategies, finalizing the protocol and investigators brochure, writing the Manual of Operations, establishing a data and safety monitoring plan and initiating the IRB approval process. The U34 is not designed for the collection of preliminary data, for the conduct of pilot studies to support the rationale for a clinical study, or for the design of the study. The U34 application will include the proposed study design.
All multi-center clinical studies must complete this two-part process, unless an exemption from this requirement is obtained. The U34 grant will provide up to two years of support. Pre-approval from NIDDK will be required for submission of an U34 application. U34 applications will be peer reviewed by special emphasis panels set up by the NIDDK Review Branch.
The product of an awarded U34 will be an application (U01) to conduct the clinical study. It is expected that receipt of a U34 grant will lead to the timely submission of an application for support of the full-scale study, incorporating the elements developed under the planning grant. Prospective applicants should note that funding of a U34 does not guarantee or imply funding for a subsequent application.
Multi-Center Clinical Study Grant (U01)
NIDDK will accept, peer review, and consider for funding applications for multi-center clinical studies only from U34 awardees, except in cases where an exemption from this requirement has been provided by NIDDK. In order not to delay the initiation of the multi-center clinical study (U01), the peer review and award of grant will be completed within four months of the receipt of the application when possible.
More detailed instructions regarding the multi-center clinical study application process are contained in two program announcements, see below. The instructions under each PA give the details pertaining to the preparation and submission of the approval request letter.
PA: NIDDK Multi-Center Clinical Study Implementation Planning Grants (U34)
Instructions for preparing and submitting a U34 Approval Request Letter
PA: NIDDK Multi-Center Clinical Study Cooperative Agreement (U01)
Instructions for preparing and submitting a U01 Approval Request Letter
Frequently Asked Questions
U34/U01 Mechanism
Introduction
Logistics
Application Process
Peer Review
Revised U34 Multi-Center Clinical Study Implementation Planning Grant Applications
U01 Multi-Center Clinical Study Cooperative Agreement
Introduction
1. What are the U34 Multi-Center Clinical Study Implementation Planning Grant and the U01?
2. Why is NIDDK requiring a U34 Multi-Center Clinical Study Implementation Planning Grant before they will fund a U01 Multi-Center Clinical Study Cooperative Agreement?
3. Is the U34 Multi-Center Clinical Study Implementation Planning Grant limited to multi-center clinical trials?
4. What administrative study activities is the U34 Multi-Center Clinical Study Implementation Planning Grant designed to support?
5. Can the U34 Multi-Center Clinical Study Implementation Planning Grant be used to collect preliminary data or to conduct a pilot study in preparation for a multi-site clinical study?
6. Can the U34 Multi-Center Clinical Study Implementation Planning Grant be used to support a group of investigators who wish to meet and plan a multi-center study?
Logistics
1. How many years of support and what level of funding will the U34 Multi-Center Clinical Study Implementation Planning Grant mechanism provide?
2. Do all U34 Multi-Center Clinical Study Implementation Planning Grant applications have to request two years of funding to complete the administrative planning process?
3. Will renewal applications be accepted for U34 Multi-Center Clinical Study Implementation Planning Grant?
4. If a U34 Multi-Center Clinical Study Implementation Planning Grant is awarded, what role will NIDDK have in the implementation of the grant?
Application Process
1. What should I do if I want to submit a U34 Multi-Center Clinical Study Implementation Planning Grant?
2. The PAR says I do not have to submit a letter of intent but I do have to obtain approval to submit the application. This seems contradictory.
3. How far in advance of the U34 Multi-Center Clinical Study Implementation Planning Grant application receipt date should written requests to NIDDK for permission to apply for this grant mechanism be submitted?
4. What information should be included in a letter requesting permission to apply for a U34 Multi-Center Clinical Study Implementation Planning Grant? What is the maximum length of a written request for approval?
5. How should requests for permission to apply for a U34 Multi-Center Clinical Study Implementation Planning Grant be submitted?
6. Is a U34 Multi-Center Clinical Study Implementation Planning Grant always required by NIDDK before a multi-center clinical study can be funded?
7. How may requests for exemption from a U34 Multi-Center Clinical Study Implementation Planning Grant be submitted?
8. If a U34 Multi-Center Clinical Study Implementation Planning Grant is awarded, will NIDDK guarantee that a subsequent U01 Multi-Center Clinical Study Cooperative Agreement will also be awarded?
Peer Review
1. How will a U34 Multi-Center Clinical Study Implementation Planning Grant application be peer-reviewed?
2. When are the receipt dates for U34 Multi-Center Clinical Study Implementation Planning Grant applications?
3. Since the U34 Multi-Center Clinical Study Implementation Planning Grant only supports administrative activities to prepare to conduct the clinical study, why does the peer-review of the U34 include a review of the rationale and design of the proposed clinical study?
4. Since the U34 Multi-Center Clinical Study Implementation Planning Grant will only support administrative planning (e.g., protocol finalization, manual of operations development) required before subject recruitment can occur, how will peer-review evaluate the significance of a U34 Multi-Center Clinical Study Implementation Planning Grant application?
5. Since the U34 Multi-Center Clinical Study Implementation Planning Grant will only support administrative planning (e.g., protocol finalization, manual of operations development) required before subject recruitment can occur, how will peer-review evaluate the innovation of a U34 grant application?
6. How will the approach of the U34 Multi-Center Clinical Study Implementation Planning Grant application be evaluated? Will the peer-reviewers evaluate the approach of the multi-center clinical study or the approach of the U34 planning activities proposed in the application?
Revised U34 Multi-Center Clinical Study Implementation Planning Grant Applications
1. If a U34 Multi-Center Clinical Study Implementation Planning Grant application is not funded upon initial submission, must applicants request approval from NIDDK to revise and resubmit the application?
2. What are the receipt dates for revised U34 Multi-Center Clinical Study Implementation Planning Grant applications?
U01 MULTI-CENTER CLINICAL STUDY COOPERATIVE AGREEMENT
1. What is a U01 Multi-Center Clinical Study Cooperative Agreement Award?
2. If the U34 Multi-Center Clinical Study Implementation Planning Grant is appropriately productive (e.g., protocol finalization, manual of operations development), will a U01 Multi-Center Clinical Study Cooperative Agreement application still require peer-review?
3. Why will U01 applications undergo peer-review if the multi-center clinical study has already been peer-reviewed as a part of the U34 Multi-Center Clinical Study Implementation Planning Grant?
4. How long after submission of the U01 Multi-Center Clinical Study Cooperative Agreement will NIDDK take to review and make a funding decision?
5. What role will NIDDK play in U01 Multi-Center Clinical Study Cooperative Agreement grant?
Introduction
1. What are the U34 Multi-Center Clinical Study Implementation Planning Grant and the U01 Multi-Center Clinical Study Cooperative Agreement Grant?
The U34/U01 funding mechanisms are two-part grant mechanisms that combine 1) an implementation planning (U34) grant followed by (2) a cooperative agreement (U01) to conduct a clinical study. Investigators interested in conducting an NIDDK-funded multi-center clinical study must receive a U34 Multi-Center Clinical Study Implementation Planning Grant before a U01 Multi-Center Clinical Study Cooperative Agreement grant will be awarded, except in cases where an exemption is granted.
2. Why is NIDDK requiring a U34 Multi-Center Clinical Study Implementation Planning Grant before they will fund a U01 Multi-Center Clinical Study Cooperative Agreement?
Clinical studies require extensive administrative planning (e.g., protocol finalization, manual of operations development, case report form design, data management and study oversight, etc.) before participant recruitment may begin. These activities require significant resources and personnel; thus, the administrative planning process typically begins after the study has been peer-reviewed and funded. The U34 Multi-Center Clinical Study Implementation Planning Grant mechanism will provide sufficient time and funds to complete detailed clinical study activities/documents necessary to comply with NIDDK standards and regulatory requirements. The product of an awarded U34 Multi-Center Clinical Study Implementation Planning Grant will be an application (U01 Multi-Center Clinical Study Cooperative Agreement) to conduct the clinical study.
After successfully completing the administrative implementation activities of the U34 Multi-Center Clinical Study Implementation Planning Grant, investigators can apply for a U01 Multi-Center Clinical Study Cooperative Agreement grant and request up to 5 years to conduct the clinical study.
3. Is the U34 Multi-Center Clinical Study Implementation Planning Grant limited to multi-center clinical trials?
No. The U34 Multi-Center Clinical Study Implementation Planning Grant mechanism is designed to support the planning activities of all types of multi-center clinical studies including epidemiologic studies, observational studies, and interventional clinical trials.
4. What administrative study activities is the U34 Multi-Center Clinical Study Implementation Planning Grant designed to support?
Study-related activities conducted during the U34 Multi-Center Clinical Study Implementation Planning Grant will depend on the type of clinical study (e.g., epidemiologic study, drug trial, behavior intervention). The U34 planning grant may support activities such as, but not limited to, the development/completion of the following items:
Final study protocol
Informed consent form(s) and, if applicable, assent form(s)
Investigator’s brochure or equivalent
Manual of operations including details, validation, and quality control for any non-standard clinical or laboratory/mechanistic testing which will be performed
Data monitoring and management plan
A plan for the acquisition and administration of study agent(s) or device(s)
Required Office of Human Research Protections assurances if not already in place
Complete set of suitable documents for submission to the appropriate regulatory authorities
Safety oversight plan
Detailed budget for conduct and completion of the clinical trial including funding for preparation of a final study report
Identification of clinical study site(s)
Training materials and training/certification plans for study staff
Initial IRB approval
Applicable regulatory elements of the Food and Drug Administration if an IND is needed for implementation of the research plan
Agreements with industry, as needed, to provide drugs, devices, or other resources
In the event of an award, the NIDDK and the Principal Investigator will agree on a list of milestones to be completed during the U34 Multi-Center Clinical Study Implementation Planning Grant project period.
5. Can the U34 Multi-Center Clinical Study Implementation Planning Grant be used to collect preliminary data or to conduct a pilot study in preparation for a multi-site clinical study?
No, the U34 Multi-Center Clinical Study Implementation Planning Grant is not designed for the collection of preliminary data, for the conduct of pilot studies to support the rationale for a clinical study, or for the design of the study. The proposed study design will be a key element in the peer-review of all U34 Multi-Center Clinical Study Implementation Planning Grant applications.
NIDDK supports R21 Program Announcements to support the collection of preliminary data and for conduct of pilot studies. See:
PA-06-387 Pilot and Feasibility Clinical Research Grants in Diabetes, Endocrine and Metabolic Diseases (R21) http://grants.nih.gov/grants/guide/pa-files/PA-06-387.html
PA-06-301 Pilot and Feasibility Clinical Research Studies in Digestive Diseases and Nutrition (R21) http://grants.nih.gov/grants/guide/pa-files/PA-06-301.html
PA-06-256 Exploratory/Developmental Clinical Research Grants in Obesity (R21) http://grants.nih.gov/grants/guide/pa-files/PA-06-256.html
PAR-06-113 Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (R21) http://grants.nih.gov/grants/guide/pa-files/PAR-06-113.html
6. Can the U34 Multi-Center Clinical Study Implementation Planning Grant be used to support a group of investigators who wish to meet and plan a multi-center study?
No, the U34 Multi-Center Clinical Study Implementation Planning Grant is not designed for this purpose. The U34 application must include details of the proposed study design, which will be critically evaluated during the peer-review process.
Logistics
1. How many years of support and what level of funding will the U34 Multi-Center Clinical Study Implementation Planning Grant mechanism provide?
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total project period for an application submitted in response to the U34 Multi-Center Clinical Study Implementation Planning Grant funding opportunity may not exceed two years. Applicants may request up to $250,000 in direct costs per year (excluding consortium Facilities and Administrative [F&A] costs). The funds requested are expected to vary based on the number of clinical sites involved in the study and the complexity of the study.
2. Do all U34 Multi-Center Clinical Study Implementation Planning Grant applications have to request two years of funding to complete the administrative planning process.
No, U34 Multi-Center Clinical Study Implementation Planning Grant applications are not required to request two years of funding. Applicants may request less than 2 years of funding if, in the applicants’ judgment, the planning process will require less than 2 years of grant support.
3. Will renewal applications be accepted for U34 Multi-Center Clinical Study Implementation Planning Grant?
No, renewal applications will not be accepted for U34 Multi-Center Clinical Study Implementation Planning Grant grants. The U34 grant mechanism will provide up to a maximum of 2 years of funding to support the planning activities required of new projects.
4. If a U34 Multi-Center Clinical Study Implementation Planning Grant is awarded, what role will NIDDK have in the implementation of the grant?
The U34 Multi-Center Clinical Study Implementation Planning Grant 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 the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under Section VI. 2. Administrative Requirements, Cooperative Agreement Terms and Conditions of Award in PAR-08-057 http://grants.nih.gov/grants/guide/pa-files/PAR-08-057.html.
Application Process
1. What should I do if I want to submit a U34 Multi-Center Clinical Study Implementation Planning Grant?
All applicants must submit a written letter of request soliciting NIDDK’s approval to submit a U34 Multi-Center Clinical Study Implementation Planning Grant. All prospective applicants are strongly encouraged to speak with the relevant NIDDK program director (http://grants.nih.gov/grants/guide/pa-files/PAR-08-057.html) before submitting a written request for approval. The NIDDK program director can provide additional project-specific information pertinent to the U34/U01 application process.
2. The PAR says I do not have to submit a letter of intent but I do have to obtain approval to submit the application. This seems contradictory.
You do have to obtain approval from NIDDK to submit your application. This prior approval process is administratively different from submitting a “letter of intent,” which is a non-binding letter which is primarily designed to give review staff information about the number and types of applications that will be submitted to RFAs or PARs. Since you already have to obtain the prior approval, the letter of intent is not needed.
3. How far in advance of the U34 Multi-Center Clinical Study Implementation Planning Grant application receipt date should written requests to NIDDK for permission to apply for this grant mechanism be submitted?
NIDDK will need sufficient time to thoroughly review letters of request in order to determine the acceptability of individual U34 Multi-Center Clinical Study Implementation Planning Grant applications. Therefore, letters of request should be submitted a minimum of six (6) weeks prior to the desired receipt date. Although six weeks is the minimum amount of time mandated by NIH, it is to the applicant’s advantage to allow as much time as possible, since the pre-approval process requires multiple levels of review. In general, it is the Institute’s experience that applications for multi-center clinical studies may be scientifically meritorious but often need further work before they are ready for NIDDK to accept them. Allotting more than 6 weeks to the pre-approval process will allow time for revisions, should they need to be made.
4. What information should be included in a letter requesting permission to apply for a U34 Multi-Center Clinical Study Implementation Planning Grant? What is the maximum length of a written request for approval?
Information related to the content and format of the letter of request can be found on the following website: http://www2.niddk.nih.gov/Research/ClinicalResearch/Infomulticenterclinicalstudyu34.htm
5. How should requests for permission to apply for a U34 Multi-Center Clinical Study Implementation Planning Grant be submitted?
Letters requesting permission to apply should be submitted to the appropriate program director for the subject matter of the application. See the NIDDK web site to identify the correct program director for your application. http://www2.niddk.nih.gov/Research/ScientificAreas/. If you are not sure of the appropriate program director, you can contact one of the program directors designated as contacts for information in the PAR and you will be directed to the appropriate individual. http://grants.nih.gov/grants/guide/pa-files/PAR-08-057.html#sectionVII
6. Is a U34 Multi-Center Clinical Study Implementation Planning Grant always required by NIDDK before a multi-center clinical study can be funded?
A U34 Multi-Center Clinical Study Implementation Planning Grant is required by NIDDK before a multi-center clinical study is funded by a U01 mechanism, except in cases where an exemption from this requirement has been provided by NIDDK.
7. How may requests for exemption from a U34 Multi-Center Clinical Study Implementation Planning Grant be submitted?
Investigators who believe that they have completed all the steps normally conducted during the U34 Multi-Center Clinical Study Implementation Planning Grant phase of the two-part grant process (U34/U01) may request an exemption from the U34 planning grant requirement. Investigators seeking such an exemption should contact the appropriate NIDDK program officer as identified in the Multi-Center Clinical Study Implementation Planning Grant program announcement: http://grants.nih.gov/grants/guide/pa-files/PAR-08-057.html#SectionVII
8. If a U34 Multi-Center Clinical Study Implementation Planning Grant is awarded, will NIDDK guarantee that a subsequent U01 Multi-Center Clinical Study Cooperative Agreement will also be awarded?
No. Prospective applicants should note that obtaining a U34 Multi-Center Clinical Study Implementation Planning Grant award does not guarantee or imply funding for a subsequent U01 Multi-Center Clinical Study Cooperative Agreement application. If the planning phase is not successful, the NIDDK may decide not to allow a U01 Multi-Center Clinical Study Cooperative Agreement application. All U01 Multi-Center Clinical Study Cooperative Agreement applications will be peer-reviewed, and NIDDK will consider the results of the peer-review process when deciding whether to support the U01 Multi-Center Clinical Study Cooperative Agreement.
Peer Review
1. How will a U34 Multi-Center Clinical Study Implementation Planning Grant application be peer-reviewed?
U34 Multi-Center Clinical Study Implementation Planning Grant applications will be peer reviewed by special emphasis panels set up by the NIDDK Review Branch. Specific review criteria used to evaluate U34 applications may be found on pages 16-18 of PA-08-057 NIDDK Multi-Center Clinical Study Implementation Planning Grants (U34):
http://grants.nih.gov/grants/guide/pa-files/PAR-08-057.html#SectionV
2. When are the receipt dates for U34 Multi-Center Clinical Study Implementation Planning Grant applications?
March 19, 2008
November 18, 2008
June 23, 2009
March 18, 2010
3. Since the U34 Multi-Center Clinical Study Implementation Planning Grant only supports administrative activities to prepare to conduct the clinical study, why does the peer-review of the U34 include a review of the rationale and design of the proposed clinical study?
NIDDK will only support the planning phase of a multi-center clinical study if the proposed clinical study is worthy of support. Therefore, the review of the U34 Multi-Center Clinical Study Implementation Planning Grant will include the rationale and design of the proposed clinical study. If the clinical study is not significant, innovative and/or likely to answer the proposed research question, NIDDK may decide that the proposed clinical study does not meet the criteria for support of the planning phase of the study.
4. Since the U34 Multi-Center Clinical Study Implementation Planning Grant will only support administrative planning (e.g., protocol finalization, manual of operations development) required before subject recruitment can occur, how will peer-review evaluate the significance of a U34 Multi-Center Clinical Study Implementation Planning Grant application?
The significance of the U34 Multi-Center Clinical Study Implementation Planning Grant application will be evaluated on the significance of the multi-center clinical study to be conducted after the planning phase of the U34. At a minimum, reviewers will be asked to evaluate the following questions:
Does the proposed multi-center clinical study addresses an important problem?
Is the significance and need to perform a future clinical study adequately justified?
Does the background support the rationale for the study?
Are the study objective(s) and hypothesis(es) adequately defined?
If the aims of the multi-center clinical study are achieved, how will scientific knowledge or clinical practice be advanced?
What will be the effect of these multi-center studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Would the results of the proposed study be likely to affect health care policy or practice in the specific area of research?
If mechanistic studies are proposed, are they appropriate and will they provide important scientific information?
5. Since the U34 Multi-Center Clinical Study Implementation Planning Grant will only support administrative planning (e.g., protocol finalization, manual of operations development) required before subject recruitment can occur, how will peer-review evaluate the innovation of a U34 grant application?
Reviewers will be asked to evaluate the innovation of the proposed study based on the rationale and design of the multi-center clinical study to be conducted after the planning phase of the U34. Reviewers may be asked to address questions such as, but not limited to, the following:
Is the multi-center clinical study to be conducted after the U34 planning phase original and innovative?
Does the project challenge existing paradigms or clinical practice;
Will the study address an innovative hypothesis or critical barrier to progress in the field?
Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
6. How will the approach of the U34 Multi-Center Clinical Study Implementation Planning Grant application be evaluated? Will the peer-reviewers evaluate the approach of the multi-center clinical study or the approach of the U34 planning activities proposed in the application?
Both the approach of the U34 planning activities and of the proposed multi-center clinical study will be evaluated during peer-review of the U34 Multi-Center Clinical Study Implementation Planning Grant. Peer-reviewers will be asked to evaluate the following questions:
Will the study concept and design, methods, and analyses, including preliminary statistical analyses, successfully accomplish the aim(s) of the proposed clinical study?
Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project?
Are the activities proposed for the planning period adequate (Refer to Part II, Section 1, Scope in the RFA http://grants.nih.gov/grants/guide/pa-files/PAR-08-057.html#SectionII) Will the activities proposed be sufficient to allow for timely and successful study implementation?
Does the applicant acknowledge potential problem areas and consider alternative tactics?
Will the proposed planning activities address all major barriers that may confront the U01 clinical study, if accepted?
For applications designating multiple PDs/PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PDs/PIs?
Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts?
Revised U34 Multi-Center Clinical Study Implementation Planning Grant Applications
1. If a U34 Multi-Center Clinical Study Implementation Planning Grant application is not funded upon initial submission, must applicants request approval from NIDDK to revise and resubmit the application?
Yes, Investigator(s) will need to request NIDDK’s permission to resubmit a U34 Multi-Center Clinical Study Implementation Planning Grant application if the initial U34 Implementation Planning Grant application is not funded. NIDDK will consider the comments of the peer-reviewers in deciding whether a U34 Multi-Center Clinical Study Implementation Planning Grant application may be resubmitted. If the original review panel does not believe that the planned multi-center clinical study is worthwhile, NIDDK may refuse submission of a revised U34 Multi-Center Clinical Study Implementation Planning Grant application.
2. What are the receipt dates for revised U34 Multi-Center Clinical Study Implementation Planning Grant applications?
March 19, 2008
November 18, 2008
June 23, 2009
March 18, 2010
U01 MULTI-CENTER CLINICAL STUDY COOPERATIVE AGREEMENT
1. What is a U01 Multi-Center Clinical Study Cooperative Agreement Award?
The cooperative agreement (U01) is an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of multi-center clinical study activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role. Thus, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as described in the following program announcement: http://grants.nih.gov/grants/guide/pa-files/PAR-08-058.html.
2. If the U34 Multi-Center Clinical Study Implementation Planning Grant is appropriately productive (e.g., protocol finalization, manual of operations development), will a U01 Multi-Center Clinical Study Cooperative Agreement application still require peer-review?
Yes. U01 Multi-Center Clinical Study Cooperative Agreement application will undergo NIH peer-review. Specific review criteria used to evaluate U01 applications may be found within PAR-08-058 NIDDK Multi-Center Clinical Study Cooperative Agreement (U01) http://grants.nih.gov/grants/guide/pa-files/PAR-08-058.html#SectionVI2
3. Why will U01 applications undergo peer-review if the multi-center clinical study has already been peer-reviewed as a part of the U34 Multi-Center Clinical Study Implementation Planning Grant?
The peer-review of the U01 Multi-Center Clinical Study Cooperative Agreement will evaluate whether the proposed study remains scientifically important and feasible. During the multi-center clinical study planning of the U34 Multi-Center Clinical Study Implementation Planning Grant, changes in the study protocol may be necessary to accommodate advances in the scientific field. Furthermore, the rationale and/or significance of the proposed study may become obsolete. Therefore, peer-reviewers will be asked to re-evaluate the significance, innovation, and approach criteria as described above.
4. How long after submission of the U01 Multi-Center Clinical Study Cooperative Agreement will NIDDK take to review and make a funding decision?
In order not to delay the initiation of the study, the peer review and award of a U01 grant will be completed within four months of the receipt of the U01 Multi-Center Clinical Study Cooperative Agreement application, when possible.
5. What role will NIDDK play in U01 Multi-Center Clinical Study Cooperative Agreement grant?
The U01 Multi-center Clinical Study funding mechanism 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 directing and executing the proposed multi-center clinical study with NIH staff being substantially involved as a partner with the Principal Investigator, as described under Cooperative Agreement Terms and Conditions of Award in PAR-08-058http://grants.nih.gov/grants/guide/pa-files/PAR-08-058.html#SectionVI2.
