An RTSM system is the tool of choice for clinical trial subject randomization and management, drug assignment, and inventory control. The RTSM system is often the first point of entry for subject data before it is pushed to the EDC housing the clinical database. So when it’s time to hold the startup meeting with your RTSM partner, you won’t want to waste any time.
But what do you need to bring to the table to help get the RTSM up and running efficiently on your project?
Check out our five tips for Sponsor/CRO Project Managers (PMs) on how to approach the startup meeting with your RTSM vendor:
1. Make sure your study team has a demo of the RTSM 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.
2. Make sure ALL stakeholders/decision-makers are included in the RTSM 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. Be sure both blinded and unblinded users are represented at the meeting.
3. Prepare a detailed checklist of protocol specifics to share and confirm with the RTSM study team. Realize that while the RTSM vendor has reviewed the protocol, you are the expert on the protocol’s requirements, idiosyncrasies, and special needs that the trial entails. The RTSM 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 RTSM 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 RTSM vendor to produce a credible first draft of the User Requirements Specification (URS) for the project
4. Confirm your understanding of the scope – i.e., system functionality/modules — with the RTSM team. You can expect the RTSM 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. Use the startup meeting to clarify the SOW and identify any contract modifications that might be required.
For example, the initial scope may have included a static automatic resupply, but during startup discussions, it may become obvious to the RTSM PM that a predictive approach would better serve the study. Similarly, it may originally have been thought that a temperature deviation module was not important for study analyses, only to learn that it will be helpful if the sites can upload temp tale data into the RTSM so that the Supply Manager can decide if the drug is usable or not.
5. Discuss Project Coordination. Ideally, the logistics of team interaction are put in place at the RTSM startup meeting. For example:
Agree on communication, meeting plans, and procedures – expect a draft communication manual (which includes contact information) from the RTSM PM before go-live
Understand sign-off processes – who will be authorized to sign which types of documents (including specifications, data or configuration change requests, data imports, etc.)
Engage the RTSM 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 RTSM 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 RTSM 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 RTSM 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 enhanced smooth sailing – from early startup to RTSM live.