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