Effective IRT Startup Meetings – Tips for Sponsors and CROs

An IRT (Interactive Response Technology) is the tool of choice for clinical trial subject randomization and management, drug assignment and inventory management, and shipping. The IRT system is often the first point of entry for subject data that is then typically pushed to the EDC housing the clinical database. So when it’s time to hold the startup meeting with your IRT partner, you won’t want to waste any time.

But what do you need to bring to the table to help get the IRT up and running efficiently on your project?

Here are five tips for Sponsor/CRO Project Managers (PMs) on how to approach the startup meeting with your IRT vendor:

  • Make sure your study team has a demo of the IRT system prior to the startup meeting. This helps enormously in visualizing potential issues, special needs, and new questions related to your use of the system for your project.

  • Make sure ALL stakeholders/decision-makers are included in the IRT startup meeting. These include (at a minimum) the Client PM and representatives from Clinical Operations (perhaps the Lead CRA), Biostatistics, Data Management, and Clinical Supplies. In addition, you may want to include leads from Regulatory Affairs (for medical monitoring), Drug Safety, and Quality Assurance. Be sure both blinded and unblinded users are represented at the meeting.

  • Prepare a detailed checklist of protocol specifics to share and confirm with the IRT study team. Realize that while the IRT vendor has reviewed the protocol, you are the expert on the protocol’s requirements, idiosyncrasies, and special needs that the trial entails. The IRT study team will have made basic assumptions and interpretations based on the protocol document, but they expect that the Client PM will bring the fleshed-out details, procedures, concerns, and caveats of the project to the meeting. Be prepared to discuss randomization (if applicable), data formats, the visit schedule (hard vs. soft windows), Dosing and titration schemes/dose calculations, packaging of the Investigative Product, the supply chain set-up (manufacturer, labeler, central warehouse vs. regional depots) and resupply. If the IRT is managing the subject diary, have a good starting point on the number of questions, types of questions, and how frequently they will be asked. The goal is to enable the IRT vendor to produce a credible first draft of the User Requirements Specification (URS) for the project

  • Confirm your understanding of the scope – i.e., system functionality/modules — with the IRT team. You can expect the IRT PM to bring the contracted Scope of Work (SOW) to the meeting, but it is not uncommon for study needs to change between bid and startup, resulting in a needed change in the SOW.

For example, the initial scope may have included a static automatic resupply but during startup discussions, it may become obvious to the IRT PM that a predictive approach would better serve the study. Similarly, it may originally have been thought that temperature deviation was not important for study analyses, only to learn that temperature information will need to be captured in the IRT after all. Use the startup meeting as a good place to clarify the SOW and identify any contract modifications that might be required.

  • Discuss Project Coordination. Ideally, the logistics of team interaction are put in place at the IRT startup meeting. For example:

    • Agree on communication, meeting plans, and procedures – expect a draft communication manual (which includes contact information)from the IRT PM before go-live

    • Understand signoff processes – who will be authorized to sign which types of documents (including specifications, data or configuration change requests, data imports, etc.)

    • Engage the IRT PM in a description of the startup and change processes to be used on the study, including all documentation/signoff points you can expect. For example, how does the system move from validation by the IRT team to User Acceptance Testing by the Client team to a final Release to Production authorization? What are all the signoff points that will arise during the study? How are mid-course configuration changes handled?

    • Basic timelines – expect the IRT PM to provide a general outline of the timelines for deliverables, and expect a follow-up after the meeting with more specific dates and any potential issues

To sum it up, bring to the IRT startup meeting all the things you are worried about, things you believe are pivotal to the study, and all the potential critical risks you see. Your effort will be rewarded by an enhanced ‘smooth sailing’ from early startup to IRT live.

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