Study Start Up

The purpose of the Study Start Up stop is to create and implement the Trial plans to ensure all the necessary elements are ready to conduct the trial. This includes:

• performing a feasibility study to identify appropriate sites / site types
• selecting the PI(s) and sub-investgators, including any virtual research sites
• preparing the contracts and agreements that will be needed for the Clinical Trial,
• preparing and submitting the required Ethics and Regulatory filings, including any patient facing recruitment documents or messages, including the ICF
• configuring and testing the DCT System, or platform
• identifying the supplies needed for the trial
• defining workflows for supplies to be available for trial visits, aligned to DCT options defined in the protocol
• identifying vendors to provide both technology and/or services for the trial and how their processes
• identifying which sites and or site-types (e.g. mobile research unit, pharmacy based unit, mobile nursing, etc) will participate in the trial and in what ways
• ensuring the sites are prepared with supplies and trained staff, including plans to support PI Oversight of any assessments done at an alternate location, and
• developing/documenting how the trial will be monitored.

Prior to the trial starting, two gating events must occur:

• study specific DCT System configuration must be on-line ("live")
• the trial must be approved by ethics and regulatory bodies