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*  RFA-NS-19-027: Human Three-Dimensional Cell Model Systems for Alzheimer's Disease-Related Dementias (ADRDs) (UG3/UH3 Clinical...
UG3/UH3 Clinical Trial Not Allowed) RFA-NS-19-027. NINDS ... Thus, criteria in research protocols that target or exclude ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical ... Clinical Trial? Not Allowed: Only accepting applications that do not propose clinical trials Need help determining whether you ... Extensive characterization and clinical-pathological staging of the disease models with the corresponding stages of clinical ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-19-027.html
*  RFA-TR-19-003: HEAL Initiative: Tissue Chips to Model Nociception, Addiction, and Overdose (UG3/UH3 Clinical Trial Not Allowed)
UG3/UH3 Clinical Trial Not Allowed) RFA-TR-19-003. NCATS ... Thus, criteria in research protocols that target or exclude ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical ... establishing the pre-clinical foundation that will inform clinical trial design. To achieve this, the applications will focus ... deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols, project ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-19-003.html
*  RFA-FD-13-001: Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)
Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) RFA-FD-13-001. FDA ... The clinical protocol should comply with ICHE6 Good Clinical Practice Consolidated Guidance which sets an international ethical ... The date the subject protocol was submitted to FDA for the IND/IDE review should also be provided. Protocols that would ... "applicable clinical trials." FDAAA defines the types of clinical trials that are "applicable clinical trials" and, therefore, ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-13-001.html
*  PAR-08-062: Alzheimers Disease Pilot Clinical Trials (R01)
Alzheimers Disease Pilot Clinical Trials (R01) PAR-08-062. NIA ... e. Detailed protocol with standardized procedures that will be ... a. Sequence of clinical studies, including the proposed pilot study, which will result in a definitive clinical trial.. b. ... The objective of the Alzheimers Disease Pilot Clinical Trials initiative is to improve the quality of clinical research ... The objective of the Alzheimer's Disease Pilot Clinical Trials initiative is to improve the quality of clinical research ...
https://grants.nih.gov/grants/guide/pa-files/PAR-08-062.html
*  PAR-18-691: Innovative Therapies and Tools for Screenable Disorders (R21 Clinical Trial Optional)
Multidisciplinary clinical trials of therapeutic protocols for treating these conditions using validated health outcome markers ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical ... In addition, for applications involving clinical trials. Are the scientific rationale and need for a clinical trial to test the ... In addition, for applications involving clinical trials:. A proposed Clinical Trial application may include study design, ...
https://grants.nih.gov/grants/guide/pa-files/PAR-18-691.html
*  PAR-18-555: Understanding and Modifying Temporal Dynamics of Coordinated Neural Activity (R01) and Clinical Trial Optional
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical ... clinical efficacy, clinical effectiveness, management and/or implementation. For more information, please refer to the Clinical ... In addition, for applications proposing clinical trials. Are the scientific rationale and need for a clinical trial to test the ...
https://grants.nih.gov/grants/guide/pa-files/PAR-18-555.html
*  PA-18-323: Fundamental Science Research on Mind and Body Approaches (R01 - Clinical Trial Optional)
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or ... primary outcomes are clinical endpoints (e.g., clinical pain assessments), although clinical endpoints may be measured as ... Human Subjects and Clinical Trials Information. When involving NIH-defined human subjects research, clinical research, and/or ... In addition, for applications proposing clinical trials. Are the scientific rationale and need for a clinical trial to test the ...
https://grants.nih.gov/grants/guide/pa-files/PA-18-323.html
*  PA-18-569: Health Services and Economic Research on the Prevention and Treatment of Drug, Alcohol, and Tobacco Abuse (R01,...
... "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https:// ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical ... In addition, for applications proposing clinical trials: Are the scientific rationale and need for a clinical trial to test the ... Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is ...
https://grants.nih.gov/grants/guide/pa-files/PA-18-569.html
*  RFA-RR-07-002: National Gene Vector Biorepository and Coordinating Center (P40)
... human gene transfer protocols. The NIH created the NGVLs in response to concerns that access to clinical-grade vectors had been ... The principal function of the NGVL is to produce clinical grade vectors for pharmacology-toxicology testing and for clinical ... Inclusion of Women And Minorities in Clinical Research: It is the policy of the NIH that women and members of minority groups ... Division of Clinical Research Resources National Center for Research Resources 6701 Democracy Blvd. Room 910 Bethesda, MD 20892 ...
https://grants.nih.gov/grants/guide/rfa-files/rfa-rr-07-002.html
*  PAR-18-186: Development of Socially-Assistive Robots (SARs) to Engage Persons with Alzheimer's Disease (AD) and AD-Related...
... "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https:// ... In addition, for applications proposing clinical trials: Are the scientific rationale and need for a clinical trial to test the ... PHS Human Subjects and Clinical Trials Information. When involving NIH-defined human subjects research, clinical research, and/ ... Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is ...
https://grants.nih.gov/grants/guide/pa-files/PAR-18-186.html
*  RFA-RM-17-018: Coordinating Center for the Undiagnosed Diseases Network (UDN) Phase II (U01)
All Clinical Sites, including the NIH UDP, will be expected to utilize common investigative and data collection protocols to ... In Phase II Clinical Sites are expected to develop plans for sustaining their Clinical Sites once Common Fund support ends in ... 3. promote an integrated and collaborative community across multiple Clinical Sites and among laboratory and clinical ... and clinical investigators, provide resulting data and protocols to the broader community, and assess development of a ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-RM-17-018.html
*  PAR-18-511: Discovery of Molecular Targets for Pregnancy-Related/Induced Diseases and Development of Therapeutics to Prevent...
... "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https:// ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical ... In addition, for applications proposing clinical trials. Are the scientific rationale and need for a clinical trial to test the ... In addition, for applications proposing clinical trials:. A proposed Clinical Trial application may include study design, ...
https://grants.nih.gov/grants/guide/pa-files/PAR-18-511.html
*  PA-02-157: NIDCD INVESTIGATOR-INITIATED CLINICAL TRIALS
This initiative is designed to encourage the development and implementation of protocols examining the efficacy of ... The NIDCD will accept, review, and fund clinical trial planning grants, in response to the NIDCD Clinical Trial Planning Grant ... complete clinical trial application package. For further information regarding the NIDCD Clinical Trial Planning Grant, see: ( ... For those applications that are to be awarded $500,000 or more in direct costs in any year or support a multicenter clinical ...
https://grants.nih.gov/grants/guide/pa-files/PA-02-157.html
*  RFA-AI-19-042: Immunobiology of Xenotransplantation (U01 Clinical Trial Not Allowed)
U01 Clinical Trial Not Allowed) RFA-AI-19-042. NIAID ... Establish protocols and subcommittees, as needed, for the ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical ... Clinical trials or clinical/human studies of xenotransplantation. However, using human cells/blood as an experimental tool in ... If the project involves human subjects and/or NIH-defined clinical research, are there plans to address: 1) the protection of ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-19-042.html
*  RFA-HD-06-014: Contraceptive Development Research Centers Program (U54)
Modify protocols as required;. *Interact with the FDA concerning clinical investigations;. *Provide information to the NICHD ... Inclusion of Women And Minorities in Clinical Research: It is the policy of the NIH that women and members of minority groups ... Inclusion of Children as Participants in Clinical Research: The NIH maintains a policy that children (i.e., individuals under ... The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-HD-06-014.html
*  PA-18-369: Mentored Research Scientist Development Award (Parent K01 -Independent Clinical Trial Not Allowed)
do not complete Section 4 - Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments. ... If the applicant is proposing to gain experience in a clinical trial, ancillary study to a clinical trial or a clinical trial ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical ... an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to ...
https://grants.nih.gov/grants/guide/pa-files/PA-18-369.html
*  RFA-DK-13-002: Planning Grants for Translating CKD Research into Improved Clinical Outcomes (R34)
Planning Grants for Translating CKD Research into Improved Clinical Outcomes (R34) RFA-DK-13-002. NIDDK ... for delivery of interventions into protocols should be provided. ... If the project involves clinical research, are the plans for 1 ... Applications will not be considered responsive to this FOA if they fail to include objective clinical measures as primary ... The primary outcomes of proposed studies must include objective measures of clinical status such as blood pressure, laboratory ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-13-002.html
*  NIH Guide: CLINICAL TRIAL PLANNING GRANT
The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to ... The expected product of the Clinical Trial Planning Grant is a detailed clinical trial research plan including a complete ... clinical trials; (b) provide support for the development of a detailed clinical trial research plan, including a manual of ... clinical research, must be developed prior to submission and included in the application for a Clinical Trial Planning Grant. ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-AR-02-001.html
*  PAR-17-244: Collaborative Research Projects to Enhance Applicability of Mammalian Models for Translational Research ...
An important translational question is what are appropriate models and pre-clinical or co-clinical protocols to test ... Clinical Trial?. Clinical Trials Not Allowed for due dates on or after January 25, 2018: Only accepting applications that do ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the ... and relapse and recurrence are considerable clinical problems; effective strategies for co- and post-clinical use of mammalian ...
https://grants.nih.gov/grants/guide/pa-files/PAR-17-244.html
*  PA-18-165: Addressing Unmet Needs in Persons with Dementia to Decrease Behavioral Symptoms and Improve Quality of Life (R21...
... "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https:// ... In addition, for applications proposing clinical trials: Are the scientific rationale and need for a clinical trial to test the ... PHS Human Subjects and Clinical Trials Information. When involving NIH-defined human subjects research, clinical research, and/ ... Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is ...
https://grants.nih.gov/grants/guide/pa-files/PA-18-165.html
*  RFA-DA-19-003: Exploiting Omics Assays to Investigate Molecular Regulation of Persistent HIV in Individuals with Substance Use...
R61/R33 Clinical Trial Optional) RFA-DA-19-003. NIDA ... "applicable clinical trials" on the ClinicalTrials.gov Protocol ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical ... In addition, for applications involving clinical trials. Are the scientific rationale and need for a clinical trial to test the ... In addition, for applications involving clinical trials:. A proposed Clinical Trial application may include study design, ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-003.html
*  RFA-HL-19-001: Coordination Center for Programs to Increase Diversity Among Individuals Engaged in Health-Related Research ...
U24 Clinical Trial Not Allowed) RFA-HL-19-001. NHLBI ... The evaluation protocol should also include plans to assess the ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical ... Each SI will propose an evaluation protocol and the CC will work to coordinate these protocols across the SIs to ensure common ... diverse backgrounds into clinical research protocols, and improve the Nation's capacity to address and eliminate health ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-19-001.html
*  RFA-RM-17-011: National Metabolomics Data Repository (NMDR) (U2C)
... information and other relevant clinical data as part of the study. Clinical study designs and protocols include vital ... Incorporation of clinical datasets containing demographic information and phenotypic or clinical metadata. ... Without accompanying clinical metadata, utility of the metabolomics datasets is limited. The Data Repository or Administrative ... When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-RM-17-011.html
*  PAR-18-026: Phenotypic and Functional Studies on FOXO3 Human Longevity Variants to Inform Potential Therapeutic Target...
... "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https:// ... In addition, for applications proposing clinical trials: Are the scientific rationale and need for a clinical trial to test the ... PHS Human Subjects and Clinical Trials Information. When involving NIH-defined human subjects research, clinical research, and/ ... Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is ...
https://grants.nih.gov/grants/guide/pa-files/PAR-18-026.html
*  Key Dates & Policy Notices | grants.nih.gov
NOT-OD-17-064 NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials May 2, 2017 ... Good Clinical Practice NOT-OD-16-148‚Äč Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded ... Appendix Policy for Clinical Trial-related Materials NOT-OD-18-126 Reminder: Updated Appendix Policy Eliminates Clinical Trial- ... Clinical Trial Review Criteria NOT-OD-18-109 Revision: The NIH Announces New Review Criteria for Career Development Award ...
https://grants.nih.gov/policy/clinical-trials/key-dates-and-policy-notices.htm