Study startup is an overwhelming, time-consuming, and occasionally frustrating component of the entire research process. It is notoriously prone to delays and can derail subsequent research activities.
To ensure a seamless, swift, and successful study startup process, all stakeholders must cooperate carefully to get the study up and running.
Here is a comprehensive checklist to help clinicians and other stakeholders streamline clinical trial study startup activities.
Designing and Optimizing Protocol
The first part of any clinical trial study startup activity is to design and optimize the study protocol. This is quite significant because it dictates every other component of the research process.
The clinical study’s protocol must support the study outcome goals to ensure a result-oriented research process. Continuous optimization is also essential to ensure a trial’s success. This may include reevaluating enrollment goals and criteria, reviewing costly procedures, and other components.
Build Your Budget
Regardless of the type of research being conducted, setting a comprehensive budget is a significant step. You must get a grip on evaluating the costs of all research activities during a trial. Various factors can impact a study’s budget, and there’s a need for a thorough understanding and evaluation before devising a strong budget.
IRB Approval
As part of your clinical trial study startup activity checklist, working with an experienced IRB approval is important to streamline your activation process. Set clear expectations and maintain open and transparent communication, which will also help facilitate any future studies. Set up a study kickoff call with an IRB because it will help save a lot of time during the review.
Site Identification
The next step on your clinical trial study startup activity checklist is identifying the site for your study. Unfortunately, this is a lingering problem as it can be hard to identify sites with the appropriate patient population for a study. Suitable sites can often have staffing or resource issues. Therefore, locating your sites nicely and early is important to ensure a smooth and seamless trial.
There are a lot of other steps that need to be crossed off your list before you can conclude a trial. The process can be quite strenuous and extensive. However, introducing modern technology has certainly streamlined the trial process.
Get Started with ClinicalPURSUIT
If you’re looking for modern medical technology such as EDC software and systems, ePROs, IRT, intelligent data capture, and clinical trial supply management to improve patient engagement and retention, check out the products and services at ClinicalPURSUIT.
We provide world-class clinical trial data management solutions that enable you to conduct an effective clinical trial. Schedule a one-on-one free demo today!
