The post-approval process includes all activities performed by the investigator and HHEAR components to obtain lab results data and if requested, the results of statistical analyses. As you consider the post-approval activities, it is important to note that HHEAR cannot guarantee fulfillment of laboratory and/or data analysis services if post-approval activities are not completed on time.
To learn more about the overall post-approval process, view the education module Navigating HHEAR Post-Approval – An Overview.
1. Complete Clearance Activities
You must complete the following post-approval clearance activities before lab analyses can be scheduled. Within 8 weeks after your application is approved:
- Provide a letter from your IRB attesting that the original study consent permits the use of samples and data for your HHEAR project. This approval will indicate that data submission and subsequent data sharing for future unspecified research purposes are consistent with the informed consent of study participants from whom the data were obtained.
- Submit signed Data Submission Agreement (DSA) and Data Sharing Plan (DSP) documents. The DSA outlines your agreement with HHEAR regarding submission of data to the HHEAR Data Repository. The DSP document describes data types, data repositories to which data will be submitted, the timeline for data submission and release, and the appropriate uses of the data.
- Submit an executed HHEAR Human Material Transfer Agreement (H-MTA) and/or Environmental Material Transfer Agreement (E-MTA). These documents are used for transfer of human biological materials and environmental samples, with or without accompanying data, between an academic or research (provider) institution and a HHEAR Lab Hub.
Within 12 weeks after your application is approved:
- Complete detailed lab analysis plans with the Lab Hub. Your plan may include a pre-test of samples to confirm their fitness for the requested analyses.
- Upload epidemiological data from your parent study to the HHEAR Data Center Portal. The Data Center tells you what data to include and how to upload your data files. The Data Center must approve your data before you can ship samples to the Lab Hub(s).
For more information and helpful tips for this phase, view the education module Navigating HHEAR Post-Approval – Clearance Activities.
2. Ship Samples to Lab Hub(s)
Within 8 weeks after the Data Center approves your epidemiological data, the Coordinating Center schedules a conference call with you to discuss requirements for aliquoting, relabeling, and shipping samples. You are responsible for all costs incurred to retrieve, process, and ship samples to the Lab Hub(s).
For more information and helpful tips for this phase, view the education module Navigating HHEAR Post-Approval – Labeling & Shipping Samples.
3. Receive Laboratory Results and Statistical Reports
When the Lab Hub(s) complete the requested analyses, they submit results data to the Data Center. The time to complete the laboratory analyses is dependent several factors, such as types of analyses, number of samples, and projects already in the analysis queue. The Data Center reviews the data files and works with the Lab Hub(s) to resolve any problems. The Data Center then notifies you to download the lab results data and summary reports from the Data Center Portal.
All untargeted profiling data is provided to investigators through the Metabolomics Workbench.
If the Data Center is providing statistical analysis services, they work with you to conduct the analyses and produce reports that enable you to achieve the aims of your HHEAR project. The Data Center notifies you when the final statistical results files for your project are available on the Data Center Portal.
For more information and helpful tips for this phase, view the education module Navigating HHEAR Post-Approval – Analyses & Results.
4. Prepare to Publish
After you receive lab and statistical analysis results, and are ready to prepare your manuscript, refer to the HHEAR Publications Policy for information on discussions with Lab Hub(s) and the Data Center to determine authorship, acknowledging HHEAR in your manuscript, and registering your manuscript with HHEAR. All de-identified data from your HHEAR project (both epidemiologic data and lab results) are deposited in the HHEAR Data Repository and made available to the public following the data embargo period. For more information about the HHEAR data embargo period, refer to the HHEAR Policies for Access to Services.
For more information and helpful tips for this phase, view the education module Navigating HHEAR Post-Approval – Publication.