STEP 1: PREPARE FOR YOUR MIGRATION
When starting the migration process from your source eTMF to your target eTMF, there are a few prerequisites we’ll complete together.
Done By You:
✓ Understand and acknowledge the scope of work, meet your project team, and get onboarded to Trial Interactive.
Done For You:
✓ Trial Interactive defines the scope of work, organizes the kickoff meetings, delivers the migration plan and project schedule, and onboards you to TI.
One of the first steps in the eTMF migration process is to define the scope of work with Trial Interactive. This is an essential step in understanding the migration checkpoints. By working with Trial Interactive, you can ensure that the migration process aligns with your organizational goals.
Once you have defined the scope of work, the next step is to sign the Scope of Work (SOW) and Standard Operating Procedure (SOP) documents. These documents provide a detailed overview of the migration process, outlining the specific steps involved, timelines, and key deliverables. By signing these documents, you can ensure that everyone is on the same page and that expectations are set from the outset.
Next, you will attend a kickoff meeting with your project manager, solutions architect, solutions engineer, and clinical document services team. Following the kickoff meeting, you will receive your migration plan and project schedule. These documents detail the processes in place, the scope of the migration, and the responsibilities of each team member involved in the migration process.
Finally, as part of the onboarding process, you will be introduced to the Trial Interactive system and will receive training on how to use the system, as well as any necessary support to ensure a smooth transition to the new system.
These action items help us set a strong foundation and increase visibility throughout the migration process.
STEP 2: EXPORT YOUR SOURCE DATA
Export the Index Structure, Configuration, Audit Trail, and Documents from your source eTMF to a secure TI file share.
Done By You:
✓ Export the index structure, configuration, audit trail, and documents from your source eTMF to Trial Interactive’s secure file share.
Done For You:
✓ Trial Interactive monitors the secure file share as you upload your data.
After you have defined and signed your SOW, attended your kickoff meeting, received your migration plan and project schedule, and onboarded to the TI system, it’s time to start the migration process. The second milestone of eTMF migrations is critical. It involves providing the source export of your current eTMF system to Trial Interactive. This source export typically includes the index structure, configuration, audit trail, and documents from your previous eTMF system.
The purpose of providing the source export is to ensure that Trial Interactive’s migration team has all the necessary information to configure the new eTMF system to meet your study’s requirements. This includes understanding your previous index structure, document types, and metadata fields.
Once you export your source data, you will upload it to our secure file share, (TI Secure File Transfer Protocol, SFTP), where it is securely stored and can be accessed by the solutions architects and engineers throughout the migration process. At this time, Trial Interactive’s team will also conduct an initial analysis of the export. This analysis helps identify any potential challenges that may arise during the migration process.
Overall, providing your export allows for a smooth transition to a new eTMF system, ensuring that all the necessary information is available to configure the new system accurately.
Questions about this milestone? Contact us to discuss the process.
STEP 3: TARGET ROOM CREATION
Trial Interactive’s Certified Experts build a standard TI eTMF Room based on a standard eTMF template.
Done By You:
✓ No action needed, but be prepared to answer questions TI may have about your data.
Done For You:
✓ Trial Interactive builds a standard eTMF room based on the 3.2.0 TMF Reference Model (CDISC).
In Step Three, Trial Interactive builds a standard eTMF room based on the 3.2.0 TMF Reference Model. While our team builds the eTMF room, there is no action needed on your end.
During this step, you’ll have open lines of communication with your project manager, who will keep you updated on the progress of the eTMF room build and if we have any questions about your data.
To speed eTMF migrations, Trial Interactive uses the out-of-the-box eTMF room, which is based on the 3.2.0 TMF Reference Model that is affiliated with the Clinical Data Interchange Standards Consortium (CDISC). According to the TMF Reference Model, “Version 3.2.0 of the Reference Model reflects updated regulatory guidance and current industry best practices – making it easier for organizations to configure the TMF Reference Model to their processes, and to further improve TMF quality, completeness, and timeliness.” (1)
Should your study require a more customized eTMF room, we can build the target room based on your study requirements to accommodate the migration. However, this option comes with an increased risk of timeline extensions and higher costs than the standard out-of-the-box configuration.
1. https://tmfrefmodel.com/version-3-2-0-of-the-tmf-reference-model-launched
STEP 4: MAPPING EXERCISE
Trial Interactive Solutions Architect performs a mapping exercise to align the source and target eTMF index and metadata fields.
Done By You:
✓ No action needed, but be prepared to answer questions TI may have about your data.
Done For You:
✓ Trial Interactive Solutions Architect performs a mapping exercise to align the source and target eTMF index and metadata fields.
Step Four is a critical preparation step that reduces the risks associated with switching eTMF systems, such as missing documents or misaligned fields. During this step, there is no action needed on your end. The mapping exercise will be completed by Trial Interactive solutions architects. The purpose of this step is to ensure that the eTMF room has a field for every document and file that exists. To do this, the solutions architect notes and compares the source and target eTMF index and metadata fields on an Excel sheet and aligns them.
From this exercise, we create a Master Mapping File, which serves as a load file to automate migration. By automating the data upload, which happens during Step Five, we speed migration and reduce the risk of human error, which can lead to significant consequences such as delays in regulatory submission and inspection findings. The Master Mapping File also serves as a reference point, ensuring that the source and target eTMF are aligned.
If you have any questions about the mapping process, reach out to your project manager.
STEP 5: DOCUMENT AND METADATA IMPORT
Trial Interactive imports all documents and metadata to the new TI eTMF Room.
Done By You:
✓ No action needed, but be prepared to answer questions TI may have about your data.
Done For You:
✓ Trial Interactive imports all documents and metadata to the new TI eTMF room.
By Step Five, your eTMF room is fully prepared for our team to import the data and documents. No action is required on your end, but there may be specific scenarios that require discussion. For instance, not all source metadata may be applicable or mapped, which your project manager will address if it applies to your migration.
Trial Interactive imports all documents to the new TI eTMF room. Once the documents are loaded into the new eTMF, the metadata associated with each document is also migrated. Metadata can include information such as document name, version, date, author, and other relevant information. The data loading process is a crucial step in eTMF migration, as it ensures that documents and metadata are accurately and securely transferred to the new system.
We prioritize a seamless migration process for our clients and welcome your input, should you have any concerns.
STEP 6: MIGRATION QC VERIFICATION REPORT
TI provides a QC verification report and a walk-through verification of the new eTMF.
Done By You:
✓ Review the post-migration report and walkthrough verification of your new eTMF.
Done For You:
✓ Trial Interactive provides a QC verification report and a walk-through verification of the new eTMF.
You’ve successfully migrated to Trial Interactive eTMF and will soon experience all the benefits of our industry-leading eTMF. With TI eTMF, you’ll achieve that goal of efficiency and productivity, with no major headaches.
The final step, Step Six, provides evidence of the successful migration. You’ll receive a migration summary report detailing everything that was migrated, along with a quality control (QC) verification report that compares source and target eTMFs. Additionally, the QC report outlines the steps our team took to ensure top-quality results. These reports provide peace of mind that all files, documents, metadata, and other elements are in their proper place.
All you have to do is review the report and walk though your new eTMF with your project team. Rest assured knowing that as a Trial Interactive customer, you now have a dedicated support team to provide TMF support and education to streamline TMF compliance and remove the friction from day-to-day clinical operations.
