Data will be collected and subsequently analyzed during the Manage stage, based on protocols developed in the Plan and Propose stage. During the Setup stage, the protocol for collecting data should be reviewed to identify those logistical requirements (if any) that must be met before data can be collected. Such requirements might include the procurement of instrumentation or software specific to the measurements to be taken. Access to existing sources of data may be needed.
- 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 t the project.
- A statistician or other data analyst on the study team may be involved in designing and monitoring data collection.
- Clinical studies may engage a Data Safety and Monitoring Board (DSMB) responsible for approving and periodically monitoring the data collection protocol.
- Information technology professionals may be involved in procuring and providing support for hardware and software used for data collection, according to best technical practices.