Not all mechanistic studies are CTs, but many are. DSMP + DSMB. You can also ask your program officer for his or her thoughts. If yes: Acceptable. 2. Intervention? (NIH requires a Data and Safety Monitoring Board for multi-site clinical trials of interventions with potential risk to participants.) 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? Plan is appropriate with respect to risks to participants, complexity of study design, and methods for data analysis? Note: Not . If yes, continue to Decision Tree for Inclusion of Women Plan, Part 2 of 2. 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. 4 Ye. * (Patient/Human Subject Oriented) Yes. Is this plan acceptable? If no: Code: N as regards clinical trials. Phase III Clinical Trial*, Multisite, High-Risk? What is the actual minority representation? 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. Does the study evaluate at least one drug, biological or device product regulated by FDA? ICMJE journal? is a clinical trial. Step 4. 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) 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.” 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. What is the actual gender representation? I > I > I > I > Title: PowerPoint Presentation Clinical Trial? DSMP. Clinical Research? No. 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. ClinicalTrials.gov Registration and Results Reporting Decision Tree . a clinical trial. For an RCT, a decision tree could compare the outcomes of competing therapies for a given clinical … (Code G1) or Figure 1 shows a decision tree to determine the need of a DSM plan and/or a DSM Board. * No. If no: Human Subjects Code: N as regards clinical trials. According to the NIH DSM policies, DSM plans are required for all clinical trials of all phases for which grant support is sought. Decision Tree for NIH Clinical Trial Definition. Interventional. Is a NIH-Defined Phase III Clinical Trial proposed? Step 3. Step 4. If yes: Code: Y as regards clinical trials. to determine whether your research qualifies as a clinical trial. Continue to Step 4. 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 the study an . Proceed to Step 4. 1. NIH’s Definition of a Clinical Trial webpage provides additional context. Is a NIH-defined phase III clinical trial proposed? Yes. No Yes No No Yes Yes Yes The study is not a clinical trial. End. Is the study fully or partially-funded by NIH? DSMP Decision Tree. A four-gene decision tree signature was identified, which robustly classified TNBCs into six subtypes. 3. NIH considers the two definitions to have the same meaning. No. Continue on Part 2 of 2, Decision Tree for Inclusion of Minorities Plan. Yes. Does the PI/Sponsor intend to publish the results in an . 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