Declaration number: NOT-RM 10-008
Key dates
Release Date: 7 May 2010
Issued by the
National Institutes of Health (NIH), (http://www.nih.gov)
The purpose of the
This communication will be monitored PAR-09-027 läpikäyneen electronic SF 424 (R & r) application package to match the specific sections.
SF424 (R & R) Cover Component
12. Suggested Project. The date is determined by the duration of the tasks of approved by NIH. proposal for a General start and ending dates are 10 months and three years from the date of submission of the application.
Estimated project financing. enter a zero line (a) through (d) in the absence of X 01 (resource Access Award) use of public funds are not funds, any non-zero value is error.Budget forms must not be used in the X-01 and the applicants are not expected to request certain assets or even estimate costs.
SF424 Research & other project information
1. Human subject is related to?Check the "no" .
2. has been used vertebrate animals? Check the "no" .
5. Is a designated site research performance or eligible has been designated a historic place?Check the "no" .
7. project summary/Abstract.Project summary/summary of the application shall be notified to the broad, long-term objectives and specific targets. the abstract should make express mention of which services will be asked NIH RAID.
10 . instruments and other resources.Is not available.This annex is not included.
11. Devices.Not applicable. Is not included in this annex.
Other annexesResearchers in the field of clinical identifying the lot to which a request or IND for Toxicology should provide ready to give place to clinical studies and surveillance, the potential for human clinical trials of the protections on academic institution's commitment to the letter.Individual NIH institutes and centers may request documents and detailed descriptions of the proposed clinical studies and supervision of medicinal products for human use protections. Letter is intended to ensure the reviewers and the NIH that produce and products NIH RAID-at the exit of the clinical program is provided "as is" and the letter should indicate that the plant is committed to the IND submission of and operation of clinical trial, when the NIH RAID has been completed. in cases where the IND for Toxicology is requested, but not the undertaking clinical trials, the letter should be received, the institution is committed to the IND submission and intends to identify and confirm the commitment of the clinical trials will not be prompted to enter letters to find the. aid for researchers who intend to use the contract research organization to organize a clinical examination of the item.
PHS398 Research plan component components
All the application instructions set out in the SF424 (R & R) Application Guide is to be followed, with "Just-in-Time" of the concepts and the following additional requirements:
PHS 398 Research plan contains:
2. specific objectives.Provide a clear statement of the tasks proposed for NIH RAID contractors have been completed. reasons for studying Include scientific therapeutic applications of the pathogen, and of clinical description of the proposal. Description of the critical provisional data should be sufficiently detailed to allow peer review.
3. Investigation strategy.This section should cover the three areas.
a. meaning.Provide a brief summary of the field, which makes it possible to identify the appropriate understanding of which the possibility of an overall view of the scientific and medical. Address why the public sector funds are needed for the development of fundamental obstacles to access to the information folder and which meet the needs of non-compliance with the support of the private sector.
b. innovation.Explain why the project is represented by particularly innovative or promising approach to discuss the functionally equivalent or. related molecules already under development, and therefore the NIH should take in the light of developments in this.
c. Approach.Approach to the subsection of the application shall contain:
Provisional data:Describe the studies and data that support the proposed development tasks. the applicant shall submit the information in support of the therapeutic agent in development effectiveness.
After development plans:The applicant shall not be required to parse the investigations, supported by the NIH RAID approach, but receives them prefer. before the project approval to NIH drug development experts will draw up a pre-clinical plan proposed milestones and decision points of the plan is not included in the request for the application. Projects for one or more of the NIH RAID-services, but not all IND application to draw up the necessary services for applicants would be to parse their approach to product development to support the NIH-RAID, including proposed milestones and key decision points. invite either clinical batch production or IND projects directed at Toxicology applicants should summarize briefly plans clinical testing, including assessment of clinical efficacy. collaborators and to the institutional arrangements for monitoring and review of the internal ratings based approach.
Additional payments:The status of all current anticipated and called for support for the project sources. This summary of the status of existing, planned or ongoing negotiations with companies related to the future development of the product licensure or. This section should also include information on all grants and/or peer review, grant project-related applications, the applicant shall certainly shows how NIH RAID support to complement, support no duplicates, from other sources.
15. R esource Division plan.Not sharing the resource plan is required.
EnquiriesInterested parties can contact:
Tony Jackson
NIH RAID Program
6001 Executive Boulevard, room 2141, MD 20892
EXPRESS/COURIER: Bethesda, Rockville, MD 20852
Phone: (301) 594-4660
Email: nih-raid@mail.nih.gov
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Great information, just what I need to know. I was able to fill out a form online (http://goo.gl/08DJSj) and I find it very helpful.
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