A Checklist for Optimizing Clinical Trial Study Startup Activities
Study startup is a complicated, multi-faceted, and time-consuming component of the clinical research lifecycle, one notoriously prone to delays. The key challenge of successful, timely study startup requires careful coordination across multiple constituencies within and external to a research organization. As a result, it is easy to lose track of all the various steps necessary to activate a study efficiently and compliantly.
With this in mind, we have outlined a checklist for researchers who are looking for guidance on study startup activities. We’ve included suggestions for optimizing each step to minimize delays and set your study on a clear path for success.
About This List
Careful planning from day one is essential for study success. The primary goal is to reduce the amount of time and resources required to activate a study. Lists of various study startup activities vary widely depending on the level of detail provided. These elements are most critical and demand the most attention from sponsors, contract research organizations (CROs), monitors, and sites.
Sponsors: The trial sponsor is primarily responsible for many study startup activities including but not limited to:
- Writing the protocol
- Funding and managing the budget for the study
- Engaging a CRO to assist in the execution of the trial
- Overseeing startup activities
- Collecting, storing, and submitting the data and documents associated with the trial
CROs: Some sponsors may involve a CRO to manage components of the study. Typically, CROs are responsible for:
- Budget negotiation
- Engaging and selecting sites
- Identifying patient populations and supporting recruitment
- Overseeing training, conduct, and other processes across the study
Monitors: Typically affiliated with the sponsor, monitors ensure appropriate and safe study conduct, as well as overseeing the progress of activating a study. Whether they monitor remotely or in person, they require detailed access to key study documents, standard operating procedures (SOPs), and more at each research site involved in the study.
Research sites: Staff and investigators at the research site play a critical role in planning and conducting a clinical trial. They are responsible for but not limited to:
- Conducting clinical trial visits and procedures
- Collecting data during the visit
- Connecting with patients to recruit and retain participants
- Securing oversight committee approvals (IRB, IBC, SRC, RSC, COI, feasibility)
- Executing billing and financial workflows to maintain operations and compliance
- Communicating information to study stakeholders include status updates, essential protocol documents, and more
1. Sponsors: Design and Optimize Your Protocol
The clinical trial protocol organizes and dictates every component of study conduct. While each detail of the protocol is essential to study success, it also must holistically and realistically support study outcome goals. While many believe study startup is entirely reactive to the protocol, optimizing the protocol before it is ever in motion can greatly impact trial success. This may include reevaluating inclusion and exclusion criteria, enrollment goals, complicated or costly procedures, or other components.
Early conversations with sites and patient groups will help ensure the visits and procedures are reasonable and achievable as study theory moves to the real-life setting.
2. Sponsors: Build Your Budget
Regardless of the type of study you are planning, building the budget is step one. You must get a handle on all the costs for activities happening throughout the life of the trial. Now is the time to thoroughly consider all the potential tasks and associated fees required. Consider the following:
- Do you need help writing the protocol?
- Do you need a data monitoring committee?
- Do you need endpoint adjudication?
- Do you need assistance or consulting help on any other matter?
- Do you need specific technology to collect or exchange data across stakeholders?
All of these, and many others, will impact your study’s budget and should be accounted for at the outset.
Let data inform your budget building process. Explore our resource: Study Activation Survey Results: Budget Negotiation
3. Sponsors and Sites: Submit Materials to Your IRB for Approval
Partnering with an experienced IRB increases opportunities to streamline the activation process. As you’re beginning your partnership with your IRB, setting clear expectations for each organization is beneficial during study startup and will also help maintain the relationship for future studies.
Setting up a study kickoff call can ensure any key milestones or special requirements are understood. Scheduling this conversation upfront with an IRB will save both the sponsor and IRB time during review time.
Need additional guidance on review requirements?
- Local Versus Central IRBs: What’s the Difference?
- What Level of Review Does Your Study Need?
- Does This Study Require IBC Review?
- The Value of Early Engagement with Your IRB
4. Sponsors and CROs: Identify the Right Sites for Your Study
To streamline startup activities, it is important to identify the most efficient and appropriate sites to conduct your study while your team might have a great relationship with a physician at a particular institution, it does not mean they have the appropriate patient population to achieve enrollment goals for the trial, or their institution has the resources to efficiently launch and run a study.
Unfortunately, finding sites is a perennial problem—mostly because it is difficult to identify and connect with sites with the appropriate patient population for a study. Or once found, the sites are shown to lack sufficient staffing or resources to take on additional trials.
More than a list of sites, Advarra’s SiteIQ solution provides detailed site performance metrics synthesized from actual completed studies, providing performance metrics and insights.
5. Sponsors, CROs, and Sites: Conduct Feasibility Evaluation
Protocol feasibility is the process of reviewing clinical trial logistics to determine if the site’s available resources are sufficient for trial conduct.
Site selection is informed early and most significantly by the feasibility questionnaire, a survey sent to all prospective sites. But if those questionnaires are deployed blindly to sites before diligent site planning occurs, it can result in responses failing to tell sponsors enough about the site’s feasibility for that specific protocol.
A feasibility evaluation should include:
- Financial viability
- Available resources
- Past performance and ability to accrue
- Alignment with the study timeline
- Current staffing and turnover
- Competing trials and populations
Sites are also responsible for completing and returning site feasibility questionnaires to inform selection and identify opportunities to take part in new studies. However, many questionnaires are redundant, or may not accurately capture a site’s ability to successfully conduct a study.
6. Sponsors and Monitors: Conduct Pre-study Site Visits/Screening Visits
Pre-study visits are the final and most crucial step in selecting appropriate sites. These visits are especially vital in cases where the research team has had no prior experience with the site.
7. Sponsors and Sites: Initiate and Negotiate the Clinical Trial Agreement (CTA)
The CTA is a legally binding agreement executed between sponsors and sites; one meant to protect both parties’ rights and interests. It covers delegation of responsibilities, obligations, allocation of risk, and financial commitments. Expect negotiations around this critical document and allocate time for them.
8. Sponsors and Sites: Collect and Exchange Regulatory Documents and Critical Submissions
Collecting and exchanging what are sometimes called the “essential” documents of the study startup process, is another place where teams will typically encounter issues slowing their progress, especially as these documents are numerous and complex. They fall into three general categories:
- Federal/National Regulatory (i.e. FDA-USA, BfArM-Germany)
- Institutional review board (IRB)/ethics committee (EC) submissions
- SOP requirements
Optimizing this process centers on removing redundancies and centralizing communication and exchange. For sponsors, leverage a centralized location – like in Advarra’s Longboat Platform – to distribute, monitor, and retrieve documents across your sites globally. Centralization also minimizes requests for redundant information, or for documents you’ve already received like CV’s, training certificates, and more.
For sites, it is important to leverage site-centric technology connected with the sponsor to ensure you’re receiving essential study communications like protocol amendments or updated informed consent forms (ICFs). By bringing your own technology to this critical step in study startup, you can maximize internal workflows when deploying documents to internal teams like quickly routing for investigator signatures and sign off, as well as returning documents quickly back to the sponsor
9. Sponsors and Sites: Deploy and Complete Training
Before a study begins enrollment, all relevant site staff must receive training and completely understand their roles. Any misunderstanding—or a lack of understanding—among site staff is a main contributor to delaying study startup progress or increasing timelines due to protocol deviations. Make sure your clinical team members thoroughly understand all the procedures, clinical and administrative, required of them by providing engaging and efficient training for each study.