DCT System Configuration
The purpose of the DCT System Configuration stop is to align the study-specific clinical trial workflows to the trial design. This includes defining all aspects of the DCT systems / technologies and services needed to conduct the trial end to end, and building the trial technology and processes to match these requirements.
Description
- Identify the relevant stakeholders. The first step is to identify all of the stakeholders who will be involved in the trial. This includes the sponsor, the investigator, the CRO, and other vendors, any data management vendor, and the patients.
- Define the trial's workflow. Once the stakeholders have been identified, the next step is to define the trial's workflow. This includes identifying the tasks that need to be completed, the order in which they need to be completed, and the resources that are needed to complete them.
- Design the data flow. Once the workflow has been defined, the next step is to design the data flow. This includes identifying the data that needs to be collected, the format in which it needs to be collected, and the way in which it will be stored and analyzed.
- Select the platform. Once the workflow and data flow have been designed, the next step is to select the platform. There are a number of different platforms available, and the best platform for a particular trial will depend on the specific needs of the trial.
- Configure the platform. Once the platform has been selected, the next step is to configure it. This includes setting up the user accounts, creating the study documents, and configuring the data collection tools.
- Test the DCT System Configuration: Once the platform has been configured, test that the system performs as expected using appropriate User Acceptance Testing processes agreed upon by the stakeholders.
The configuration of a DCT clinical trial platform can be a complex process. However, by following these steps, sponsors and investigators can ensure that the platform is configured in a way that meets the needs of the trial and that complies with all applicable regulations.
Here are some additional considerations that should be taken into account when configuring a DCT clinical trial platform:
- Security: The platform must be secure to protect the confidentiality, integrity, and availability of patient data.
- Compliance: The platform must comply with all applicable regulations, including those governing the conduct of clinical trials, the protection of human subjects, and the privacy of patient data.
- Usability: The platform must be easy to use for both patients and investigators.
- Scalability: The platform must be scalable to accommodate the growth of the trial.
DCT-specific Considerations/Inputs
Data Flow Maps and Data Cleaning Requirements:
Regulatory Documents
FDA/U.S.
Europe/EMA
Reference Documents
ACRO Decentralized Clinical Trials Data Flow Maps
ViewIs your eSystem actually an eCRF (electronic case report form)?
ViewSCDM - Good Clinical Data Management Practices (GCDMP) -https://scdm.org/gcdmp/
ViewMRCT IRB/EC Considerations - Full Document
ViewMRCT IRB/EC Considerations - Participants & Technology
ViewNIH - Informed Consent for Research Using Digital Health Technologies
View