Clinical Research? Does the PI/Sponsor intend to publish the results in an . NIH considers the two definitions to have the same meaning. Continue on Part 2 of 2, Decision Tree for Inclusion of Minorities Plan. Continue to Step 4. Is a NIH-Defined Phase III Clinical Trial proposed? DSMP + DSMB. According to the NIH DSM policies, DSM plans are required for all clinical trials of all phases for which grant support is sought. End. No. ClinicalTrials.gov Registration and Results Reporting Decision Tree . What is the actual minority representation? To determine whether your research qualifies as a CT, proceed through the Decision Tree for NIH Clinical Trial Definition: considered clinical trials: • surveys, • questionnaires, • user preferences, • focus groups, • secondary research with biospecimens or health information. Clinical Trial? NIH’s Definition of a Clinical Trial webpage provides additional context. Not all mechanistic studies are CTs, but many are. NIH describes mechanistic studies as designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. Revised Common Rule §__.102(b): “Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.” * No. Consider: BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3) (RFA-NS-18-023) Exploratory Clinical Trials (U01) SBIR/STTR Exploratory Clinical Trials (R42)() NeuroNEXT Clinical Trials (U01) or (U44) StrokeNET Clinical Trials and Biomarker Studies (U01) or (U44) If yes: Acceptable. 2. I > I > I > I > Title: PowerPoint Presentation Proceed to Step 4. No. What is the actual gender representation? * (Patient/Human Subject Oriented) Yes. No Yes No No Yes Yes Yes The study is not a clinical trial. DSMP. Use NIH’s decision-making tool, Does your human subjects research study meet the NIH definition of a clinical trial? Both genders are included in scientifically appropriate numbers? Decision Tree for NIH Clinical Trial Definition Note: Not considered clinical trials: • surveys, • questionnaires, • user preferences, • focus groups, • secondary research with biospecimens or health information. If yes, continue to Decision Tree for Inclusion of Women Plan, Part 2 of 2. (NIH requires a Data and Safety Monitoring Board for multi-site clinical trials of interventions with potential risk to participants.) If no: Code: N as regards clinical trials. (Code G1) or A four-gene decision tree signature was identified, which robustly classified TNBCs into six subtypes. Plan is appropriate with respect to risks to participants, complexity of study design, and methods for data analysis? For an RCT, a decision tree could compare the outcomes of competing therapies for a given clinical … Is the study fully or partially-funded by NIH? You can also ask your program officer for his or her thoughts. Step 3. If no: Human Subjects Code: N as regards clinical trials. Decision Tree for NIH Clinical Trial Definition. Yes. a clinical trial. Yes. Interventional. 1. Does the study evaluate at least one drug, biological or device product regulated by FDA? Is this plan acceptable? If yes: Code: Y as regards clinical trials. is a clinical trial. Phase III Clinical Trial*, Multisite, High-Risk? DSMP Decision Tree. Is a NIH-defined phase III clinical trial proposed? Intervention? Figure 1 shows a decision tree to determine the need of a DSM plan and/or a DSM Board. Note: Not . 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