What is the actual minority representation? Note: Not . DSMP + DSMB. a clinical trial. Does the PI/Sponsor intend to publish the results in an . 4 3. You can also ask your program officer for his or her thoughts. ClinicalTrials.gov Registration and Results Reporting Decision Tree . What is the actual gender representation? Not all mechanistic studies are CTs, but many are. If no: Human Subjects Code: N as regards clinical trials. For an RCT, a decision tree could compare the outcomes of competing therapies for a given clinical … Yes. * No. NIH’s Definition of a Clinical Trial webpage provides additional context. Continue to Step 4. 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.” Is the study fully or partially-funded by NIH? If yes: Acceptable. A four-gene decision tree signature was identified, which robustly classified TNBCs into six subtypes. Does the study evaluate at least one drug, biological or device product regulated by FDA? Both genders are included in scientifically appropriate numbers? No. Step 4. A decision tree is a mathematical and visual representation of all possible decision options for a given choice, and the consequences that follow each, usually expressed in terms of likelihoods and utilities. Decision Tree for NIH Clinical Trial Definition. Step 3. If no: Code: N as regards clinical trials. 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. DSMP. Yes. ICMJE journal? Continue on Part 2 of 2, Decision Tree for Inclusion of Minorities Plan. Use NIH’s decision-making tool, Does your human subjects research study meet the NIH definition of a clinical trial? 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) Clinical Research? considered clinical trials: • surveys, • questionnaires, • user preferences, • focus groups, • secondary research with biospecimens or health information. No Yes No No Yes Yes Yes The study is not a clinical trial. 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. is a clinical trial. Proceed to Step 4. If yes, continue to Decision Tree for Inclusion of Women Plan, Part 2 of 2. Figure 1 shows a decision tree to determine the need of a DSM plan and/or a DSM Board. According to the NIH DSM policies, DSM plans are required for all clinical trials of all phases for which grant support is sought. (Code G1) or To determine whether your research qualifies as a CT, proceed through the Decision Tree for NIH Clinical Trial Definition: No. Step 4. Interventional. Intervention? Ye. Is a NIH-defined phase III clinical trial proposed? Is a NIH-Defined Phase III Clinical Trial proposed? 2. If yes: Code: Y as regards clinical trials. Is this plan acceptable? A Bayesian algorithm was used to integrate molecular profiles in two TNBC cohorts, followed by validation using five independent cohorts (n = 1,168), including three clinical trials. Clinical Trial? I > I > I > I > Title: PowerPoint Presentation to determine whether your research qualifies as a clinical trial. End. 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