This is the ‘active’ stage of a research study after all research approvals and permissions are in place and recruitment of participants and/or data collection begins. This stage occurs when the researchers start to follow the procedures as described in the protocol. It is a busy time usually and researchers need to be vigilant in their documentation and their reporting responsibilities to all the authorities who have a legitimate interest in the research study; these will include the ethics committee, the regulatory body, the funder, the NHS Trust, the University, the employer. Any changes to the protocol need to be dealt with following the due processes.
Keeping oversight of the conduct of a research study overall is the responsibility of the Chief Investigator and locally the Principal Investigator is responsible for the conduct of the research study at their site. This will include, of course, ensuring participant safety, rights and wellbeing and it also includes ensuring research team availability and expertise.
Delivery of a research project to “time and target” means the researchers have recruited the agreed number of participants in the agreed time. Research teams are monitored closely to ensure they meet their performance targets.