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*  PAR-18-618: NINDS Exploratory Clinical Trials for Small Business (R44) - Clinical Trial Required
NINDS Exploratory Clinical Trials for Small Business (R44) - Clinical Trial Required PAR-18-618. NINDS ... Clinical Site Monitoring Plan. Describe a Clinical Site Monitoring Plan including how site adherence to the protocol and ... Developing subsequent clinical study protocols.. (10) Multiple Trials: There may be several questions to be answered before an ... NINDS Efficacy Clinical Trials. While an exploratory clinical trial may examine clinical outcomes or biomarker outcomes as ...
https://grants.nih.gov/grants/guide/pa-files/PAR-18-618.html
*  RFA-NS-17-018: BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP (U19)
Clinical Protocol Synopsis: The clinical protocol synopsis must not exceed six pages, and must include the following ... Clinical Protocol Synopsis. These items must be uploaded as separate attachments in pdf format with filenames that correspond ... When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the ... 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-NS-17-018.html
*  RFA-NS-15-006: BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous...
Clinical Protocol Synopsis: The clinical protocol synopsis should not exceed six pages (applications that exceed this limit ... For projects proposing non-clinical (formerly pre-clinical) testing to support an IDE submission for the clinical study, an FDA ... of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical study is expected to ... of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical study is expected to ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-15-006.html
*  RFA-CA-07-506: A Data Resource for Analyzing Blood and Marrow Transplants (Limited Competition U24)
... plan new clinical trials or treatment protocols; and develop approaches to evaluating transplant outcomes. Furthermore, this ... Clinical Grants and Contracts Branch. Clinical Therapy Evaluation Program. Division of Cancer Treatment and Diagnosis. National ... Clinical Grants and Contracts Branch. Clinical Therapy Evaluation Program. Division of Cancer Treatment and Diagnosis. National ... plan new clinical trials or treatment protocols; and develop approaches to evaluating transplant outcomes. ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-07-506.html
*  RFA-DK-03-007: NONINVASIVE MEASUREMENT OF IRON BY MAGNETIC RESONANCE IMAGING
o Surveys, questionnaires, data collection instruments, and clinical protocols. These may be stapled as sets. o Original glossy ... The following are examples of basic and clinical research that could be addressed in the application of MRI to the measurement ... In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of ... 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-DK-03-007.html
*  NIH Guide: BARRETT'S ESOPHAGUS, GASTROESOPHAGEAL REFLUX DISEASE AND ADENOCARCINOMA OF THE ESOPHAGUS
The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to ... o Surveys, questionnaires, data collection instruments, and clinical protocols. These may be stapled as sets. o Original glossy ... Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH's National Center for ... Research Scope This initiative encourages further basic and clinical investigation aimed at a broad range of problems, ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-02-015.html
*  PA-03-076: BASIC AND CLINICAL STUDIES OF CONGENITAL URINARY TRACT OBSTRUCTION
BASIC AND CLINICAL STUDIES OF CONGENITAL URINARY TRACT OBSTRUCTION PA-03-076. NIDDK ... o Surveys, questionnaires, data collection instruments, and clinical protocols. These may be stapled as sets. o Original glossy ... BASIC AND CLINICAL STUDIES OF CONGENITAL URINARY TRACT OBSTRUCTION RELEASE DATE: March 5, 2003 PA NUMBER: PA-03-076 March 2, ... Many controversies and clinical uncertainties exist in the detection, prognosis, and effective treatment strategies for this ...
https://grants.nih.gov/grants/guide/pa-files/PA-03-076.html
*  NOT-OD-17-050: Reporting Preprints and Other Interim Research Products
See ClinicalTrials.gov about registration of clinical trial protocols. Citing interim research products in applications, ... These risks are especially great for clinical research, and there are examples when even peer-reviewed findings have been hyped ... Another common type of interim product is a preregistered protocol, where a scientist publicly declares key elements of their ... Further, other interim research products, such as protocols, help new investigators to document their progress and engage other ...
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-050.html
*  PAR-16-343: Limited Competition: Exploratory CTSA Collaborative Innovation Awards (R21)
If the application includes a clinical trial, the following should be included in the appendix: * Clinical Protocol Synopsis ( ... When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the ... The Clinical and Translational Science Award (CTSA) hubs promote advances in translational research and training at ... If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of ...
https://grants.nih.gov/grants/guide/pa-files/PAR-16-343.html
*  PA-06-148: Pilot and Feasibility Program Related to the Kidney (R21)
Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents. *Graphic images of ... 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/pa-files/PA-06-148.html
*  NIH Guide: MEASURES OF QUALITY OF CARE FOR VULNERABLE POPULATIONS
Does use of clinical guidelines or protocols reduce disparities in care? Does presence of interpreters improve patient ... For example, despite the fact that AHCPR-supported clinical guidelines on acute and chronic pain were published in 1992 and ... Measures applicable to the performance of health plans or institutional or clinical providers of care with respect to these ... Their particular characteristics as patients and consumers may not be well understood, as many clinical and health services ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-HS-99-001.html
*  PAR-06-521: Dissemination and Implementation Research in Health (R21)
Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents. *Graphic images of ... clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (https ... Inclusion of Women And Minorities in Clinical Research: It is the policy of the NIH that women and members of minority groups ... of clinical information and effective clinical interventions.. *Studies of efforts to implement prevention, early detection, ...
https://grants.nih.gov/grants/guide/pa-files/PAR-06-521.html
*  PA-06-229: Intestinal Failure, Short Gut Syndrome and Small Bowel Transplantation (R21)
Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents. *Graphic images of ... 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 ... Basic, translational or clinical research in small bowel transplantation, either in animal models or humans, that aim to ...
https://grants.nih.gov/grants/guide/pa-files/PA-06-229.html
*  PAR-07-049: Drug Discovery for Nervous System Disorders (R21)
Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents. *Graphic images of ... 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/pa-files/PAR-07-049.html
*  PAR-06-504: Enabling Technologies for Tissue Engineering and Regenerative Medicine (R01)
Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents. Graphic images of ... proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical ... 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 ...
https://grants.nih.gov/grants/guide/pa-files/PAR-06-504.html
*  PAR-06-556: Clinical Studies of Bisphoshonate Therapy and Osteonecrosis of the Jaws (R21)
Clinical Studies of Bisphoshonate Therapy and Osteonecrosis of the Jaws (R21) PAR-06-556. NIDCR ... Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents. *Graphic images of ... Applicants wishing to conduct clinical trials related to ONJ should apply under the NIDCR's clinical trials program that may be ... Applicants who plan to propose the conduct of a clinical trial through the NIDCR's clinical trials program are strongly ...
https://grants.nih.gov/grants/guide/pa-files/PAR-06-556.html
*  PAR-08-070: Career Development Grants in Occupational Safety and Health Research (K01)
Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.. *Graphic images of ... Quality of the candidate's research, academic and (if relevant) clinical record;. *Commitment to meeting the program objectives ... Establish the candidate's commitment to an occupational safety and health career in biomedical, clinical, social or behavioral ... non-clinical investigators, the NIOSH hopes to foster the careers of these investigators who are vital for the future ...
https://grants.nih.gov/grants/guide/pa-files/par-08-070.html
*  RFA-CE-08-001: Youth Violence Prevention through Community-Level Change (U49)
Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.. *Graphic images of ... Developing a research protocol for Institutional Review Board (IRB) review and approval by all cooperating institutions ... If applicable, the CDC IRB will review the protocol initially and on an annual basis until the project is complete. ... Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-CE-08-001.html
*  RFA-HS-12-003: Limited Competition: Continuation of Consumer Assessment of Healthcare Providers and Systems (CAHPS IV) (U18)
Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents. Graphic images of ... Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical ... Like all CAHPS products, all interview protocols, focus group discussion guides and other such materials developed for QI ... Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-HS-12-003.html
*  PAR-18-630: Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required)
Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) PAR-18-630. NIAID ... Section 4 - Protocol Synopsis. 4.6.a If yes, describe the availability of Investigational Product (IP) and Investigational New ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical ... R01 clinical trial FOA supports clinical trials that are expected to require an extended project period. A proposed clinical ...
https://grants.nih.gov/grants/guide/pa-files/PAR-18-630.html
*  PA-04-146: PILOT AND FEASIBILITY PROGRAM IN UROLOGY
Also, surveys, questionnaires, data collection instruments, and clinical protocols may be included. These may be stapled as ... INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups ... The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or ... all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II ...
https://grants.nih.gov/grants/guide/pa-files/PA-04-146.html
*  PA-06-277: In Utero Exposure to Bioactive Food Components and Mammary Cancer Risk (R21)
o Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents. ... Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical ... Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well ... how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, ...
https://grants.nih.gov/grants/guide/pa-files/PA-06-277.html
*  RFA-NS-19-001: BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the...
Clinical Protocol Synopsis: The clinical protocol synopsis must not exceed six pages; applications that exceed this limit will ... When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical ... The clinical protocol synopsis must include the following information:. *Compliance with HIPAA and informed consent must be ... Clinical Trial? Required: Only accepting applications that propose clinical trial(s) Need help determining whether you are ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-19-001.html
*  RFA-NS-18-010: BRAIN Initiative: Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating...
Clinical Protocol Synopsis: The clinical protocol synopsis must not exceed six pages; applications that exceed this limit will ... The clinical protocol synopsis must include the following information:. * Compliance with HIPAA and informed consent must be ... Applicants are required to include the following items: Team Management Plan and Clinical Protocol Synopsis. These items must ... Awardees must verify that the clinical study is performed in accord with Good Clinical Practices (GCP) and in accord with NINDS ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-18-010.html
*  RFA-DK-16-025: APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Centers (Collaborative U01)
The filename "Clinical Protocol Synopsis.pdf" should be used.. The synopsis is meant to supplement rather than duplicate the ... The final study protocol will be designed by the Clinical Center and Scientific Data Research Center Program Directors/ ... Applications that lack the Clinical Protocol Synopsis are incomplete and will not be peer reviewed. ... The Clinical Centers will be responsible, as a group, for obtaining biological samples, genetic and clinical information from ...
https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-16-025.html