Navigating HHEAR Post-Approval Phase: Analyses & Results
This module focuses on the steps involved in obtaining and analyzing laboratory data post-approval for a successful research outcome, providing guidance and tools for navigating the process effectively.
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Presentation Transcript
Navigating HHEAR Post-Approval Phase 3: Analyses & Results 1
Navigating HHEAR Post-Approval (1 of 3) The Steps of the Post-Approval process include: 2. Prepare and Ship Samples to Lab Hubs 1. Clearance Activities 3. Laboratory and Statistical Analyses 4. Publication This module will focus on this step 2
Navigating HHEAR Post-Approval (2 of 3) Objectives: Understand the steps involved in obtaining the results of laboratory and data analyses. Obtain access to guidance and tools for successfully navigating the post-approval process. 3
Navigating HHEAR Post-Approval (3 of 3) 1-2 months after DC receives lab data 6-9 months after PI receives QC ddata 6-9 months after LH receives specimens Once the samples arrive at the lab, the LH and DC complete many steps to deliver high-quality data. LH analyzes samples, preparesresults for delivery to DC, and uploads result files to DC* DC reviews & QCs the results and deposits final project data files & results in Data Repository (data/results are in embargo) Track DC works with PI on statistical analysis, if applicable 1 2 progress by analysis or assay 1PI receives lab results/data from DC. 2PI receives final statistical reports from DC, if applicable *untargeted/metabolomic results will be uploaded via the Metabolomics Workbench. 4
Laboratory & Statistical Analysis (1 of 4) 6-9 months after LH receives specimens LH analyzes samples, prepares results for delivery to DC, and uploads result files to DC* Track progress by analysis or assay # of samples Results uploaded to Data Center Samples Arrive @ Lab Lab Hub(s) complete analyses # of analyses Projects in lab queue 5
Laboratory & Statistical Analysis (2 of 4) 1-2 months after DC receives lab data 6-9 months after LH receives specimens DC reviews & QCs the results and deposits final project data files & results in Data Repository (data/results are in embargo) 1 Results uploaded to Data Center Data Results Shared with investigator Center QCs the data file Note: untargeted profiling data is provided through Metabolomics Workbench. 6
Laboratory & Statistical Analysis (3 of 4) Track your Project s Status Your project s status can be viewed on your myHHEAR dashboard under Other Project Tasks. Here you will see: Analyses initiated Analyses completed Which results have been transferred to the Data Center Status of the Data Center Quality control review Relevant comments about the analyses 7
Laboratory & Statistical Analysis (4 of 4) 1-2 months after DC receives lab data 6-9 months after PI receives QC d data Once you have received the lab results, you will work with the Data Center as needed to conduct the statistical analysis DC works with PI on statistical analysis, if applicable 2 The Data Center will deposit the final project data files and results in the data repository. 8
Reminders There are many factors that impact how long the laboratory analysis takes, including the number of specimens, the number & complexity of analysis, and the queue of the lab hub. Please be sure to respond to all HHEAR team communications promptly. Untargeted data is provided through the Metabolomics Workbench at https://www.metabolomicsworkbench.org/ The data center has many resources that you might find useful during your post- approval process. They can be accessed at https://hheardatacenter.mssm.edu/Resource/Get 9
Resources Refer to the following webpages for more information: How to Apply https://hhearprogram.org/how-apply Policies https://hhearprogram.org/policies Support Documents https://hhearprogram.org/support-docs FAQs https://hhearprogram.org/faqs Data Center Portal & Data Repository https://hheardatacenter.mssm.edu/ 10
