Data will be collected and subsequently analyzed during the Manage stage, using the protocol for collecting data developed in the Plan/Propose stage and the processes and technical resources established during the Setup stage. Strict adherence to the data collection protocol design is critical to assuring that the data collected as well as the results of their analysis can be validated.
- The Principal Investigator (PI) is responsible for the overall conduct (including administration and compliance) and results of the research, including the collection of data.
- Members of the study team who will be involved in any aspect of data collection are each responsible for observing best research, administrative and compliance practices, appropriate to their role in the project.
- A statistician or other data analyst on the study team may be involved in monitoring data collection.
- Clinical studies may engage a Data Safety and Monitoring Board (DSMB) responsible for periodically monitoring the data collection protocol.
- Information technology professionals may be involved in providing support for hardware and software used for data collection, according to best technical practices.