90 Day Start Up
Start-up performance is the dress rehearsal for enrollment performance and overall study performance. A rapid start-up not only improves trial performance but helps everyone feel confident in their part of a job well done. The 90-Day Start-Up Guideline was developed to showcase that a different approach makes all the difference, a concept we strongly believe. Pride and trust are qualities we in the coordinating and data management centers (CCC and DCC) value in chosen partners and sites. Motivation, quality, and high-performance are assets we strive to display and inspire in others.
In preparing to conduct a clinical trial, a “Study Launch” period takes place, executed by the coordinating and data management centers as well as the sponsor and study leadership. The Study Launch period is prior to the 90-Day Start-Up period, it is where study planning and staging occur behind the scenes. During this time, the coordinating and data management center teams will work diligently to build trust and strong partnerships with sponsors as a foundation for the eventual start-up period. To ensure a successful 90-Day Start-Up period, a number of deliverables must be completed on part of the CCC, DCC, sponsor, and study leadership. Such activities, visualized below, are deliverables required to meet “Go Live” – the beginning of the 90-Day Start-Up.
The 90 day delivery plan is broken down into discreet, monthly, sequential, and time-sensitive objectives that target Site Activation in 3 months, and First Patient First Visit immediately following. Electronic checklists for each month have been developed to aid sites in staying on track. These data entries will be used by the CCC to ensure roadblocks are dealt with in a timely manner to accomplish a successful completion of the 90-day commitment. When a study packet is delivered to a site containing the protocol, statement of work, contract, and informed consent template is when the clock starts for that site. Month 1 will focus on IRB submission, contract execution, and FWA’s on part of the site; a process we know to be tedious, hence why it is the first step. Month 2 solidifies the delegation of responsibilities log in order to begin collection of essential documents. The 3rd and final month of the Start-Up period is centered on training site personnel and in-servicing to prepare for Site Activation by Site Initiation Visit (SIV) or an Investigator Meeting (IM). Below a schematic outlines the topics each month consists of, showcasing that each must be complete before progressing in the 90 day timeline.
With the 90-Day Start-Up complete sites are equipped to begin enrolling patients. We are committed to creating an ongoing learning process that leads to result-oriented teams in pursuit of innovation. From Study-Planning (pre-90 Day Start-up) to First Patient-First Visit, this guideline encourages efficiency, best practices, and standards for future trials to model from. The improvements put forth by the 90-Day Start-Up Guideline will change the way we launch trials and improve our overall trial performance.