Post-Approval Phase 2 - Labeling & Shipping Samples

Navigating HHEAR Post-Approval Phase 2: Labeling & Shipping Samples 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 This module will focus on this step. 3. Laboratory and Statistical Analyses 4. Publication 2

Navigating HHEAR Post-Approval (2 of 3) Objectives: Understand the steps involved in properly labeling your samples and how to link your SIDs and PIDs. Be aware of critical activities and deadlines along the way (including how and when to ship samples.) Obtain access to guidance and tools for successfully navigating the post-approval process. 3

Navigating HHEAR Post-Approval (3 of 3) Center approves your epidemiological data upload, you will Once all clearance activities are complete and the Data 16 weeks post-approval 17-18 weeks post-approval 24 weeks post-approval begin the labeling and shipping activities CC prints sample labels and ships to PI LH sends request to PI to label, pack and ship samples PI uses DC portal to label, link SIDs, and print shipping manifest PI confirms LH is ready to receive samples & ships samples to LH(s). CC facilitates a conference call with the PI, LH, and DC. discuss sample labeling & shipping 4

Preparing to Ship Samples to Lab Hub(s) (1 of 6) 17-18 weeks post-approval As soon as all clearance activities are complete AND the Data Center approves your epidemiological data, the Coordinating Center schedules a conference call with you to discuss requirements for: CC prints sample labels and ships to PI discuss sample labeling & shipping CC facilitates a conference call with the PI, LH, and DC. Aliquoting Relabeling Shipping samples The coordinating center will print and send you the sample labels before the call. Tips It is important to have the labeling call as soon as possible to facilitate the timely completion of the subsequent steps. Review the Lab Analysis Plans these can be found on your myHHEAR dashboard. 5

Preparing to Ship Samples to Lab Hub(s) (2 of 6) 17-18 weeks post-approval After the sample labeling call, the LH will send a request to label, pack, and ship samples. LH sends request to PI to label, pack and ship samples PI uses DC portal to link SIDs and print shipping manifest Label Print Manifest Pack & Ship Use the DC portal to label samples and link SIDs to PIDs (and original specimen IDs) The Data Center Portal will generate a shipping manifest Pack and send samples to the Lab Hub(s). 6

Preparing to Ship Samples to Lab Hub(s) (3 of 6) Retrieve samples and create aliquots, as needed If your study samples are not on hand, you will need to retrieve those from storage at this point. Some studies will require aliquots to be made from the current specimens, this will be detailed in your Lab Analysis Plan. If there is any deviation in the available samples relative to the approved plan (i.e., a reduction in the number of samples), contact the HHEAR Coordinating Center at HHEAR_CC@westat.com right away. Tip Remember you will need to relabel your specimens with HHEAR specific labels, unless a waiver has been completed (https://hhearprogram.org/sites/default/files/HHEAR-WaiverRequest508.pdf). 7

Preparing to Ship Samples to Lab Hub(s) (4 of 6) Duplicates HHEAR often recommends that investigators add duplicate samples (also known as technical replicates or split samples) into HHEAR project sample sets before shipping samples to HHEAR Lab Hubs. The number of duplicate samples included in the sample sets will depend on the project size HHEAR investigators should aim for five percent or 20 samples as a maximum. The number of duplicates will be specified in your Lab Analysis Plan. Duplicate samples should have their identity masked (i.e., use containers or vials and labeling similar to the HHEAR study sample set). 8

Preparing to Ship Samples to Lab Hub(s) (5 of 6) Labeling & Linking Relabel samples with Sample ID (SID) labels from the coordinating center SID labels are printed on Freezerbondz thermal transfer labels (1 x ). These can be applied to frozen vials. Samples must be relabeled unless a waiver has been completed and approved. The waiver can be found at https://hhearprogram.org/sites/default/files/HHEAR-WaiverRequest508.pdf Link the SIDs to the PIDs (and original participant IDs) in the document provided by the Data Center it is recommended that you do this while applying the new labels. The HHEAR SID labels contain data matrix barcodes. Barcode scanners can be borrowed from the Data Center if needed. Tip The sample labeling protocol can be found at https://www.youtube.com/watch?v=g9ceEP8sKVc 9

Preparing to Ship Samples to Lab Hub(s) (6 of 6) Manifest As you link the SIDs to the PIDs (and to the original specimen IDs), the Data Center Portal will generate the shipping manifest(s) for your sample shipment(s). The manifest is a fully editable Excel file that is accessible under the Generated File section of your project details screen in the Data Center Portal. When you are ready to ship, you will need to fill in any necessary fields, such as tracking information, box position of each vial, etc. Your shipping manifest must be approved by the Data Center before samples can be shipped to the Lab Hub. Tip The sample labeling protocol can be found at https://www.youtube.com/watch?v=g9ceEP8sKVc A hard copy of the manifest should be printed and included in the shipping container and sent electronically to the LH. 10

Ship Samples to Lab Hub(s) (1 of 2) 24 weeks post-approvalShipping PIconfirms LH is ready to receive samples & ships samples to LH(s). Once SID-PID mapping is complete and the shipping manifest has been approved, the PI will coordinate a shipment date with the LH do not ship your samples before coordinating with the LH. All sample labeling activities must be complete, and samples must be shipped within 8-weeks of the approval of yourepidemiologicaldata (24-weeks post-approval). You are responsible for all costs incurred to retrieve, process, and ship samples to the Lab Hub(s). Tips A hard copy of the manifest should be printed and included in the shipping container and sent electronically to the LH. DO NOT ship until the manifest is approved by the Data Center and you have coordinated a shipment date and have received specific instructions from the Lab Hub(s). 11

Ship Samples to Lab Hub(s) (2 of 2) Once the samples have shipped, email the Lab Hub AND Coordinating Center to let them know the samples have been shipped. Include a copy of the completed manifest as an attachment to the email. 12

Ship Samples to Lab Hub(s)- Tips Tips Please see the video tutorial for additional labeling instruction: https://www.youtube.com/watch?v=g9ceEP8sKVc Discuss best shipping practices for your specimen type with the LH. We encourage you to utilize tracking for all sample shipments. Reach out to the HHEAR coordinating center at HHEAR_CC@westat.com if you have any difficulties during the shipping process! 13

Reminders Samples must be relabeled with HHEAR labels The sample labeling protocol can be found at https://www.youtube.com/watch?v=g9ceEP8sKVc SID and PIDs are must be linked within the document provided by the Data Center Samples must be shipped within 8 weeks of data approval. If you have questions, please contact the HHEAR Coordinating Center at HHEAR_CC@westat.com 14

Resources Refer to the following webpages for more information: Policies https://hhearprogram.org/policies Support Documents https://hhearprogram.org/support-docs FAQs https://hhearprogram.org/faqs Data Center Resources https://hheardatacenter.mssm.edu (click on the resources tab) Sample Labeling Protocol https://www.youtube.com/watch?v=g9ceEP8sKVc 15