This section provides information on what happens during the course of a healthcare research study, with each stage broken down into tasks (or stations on the process map) detailing activities, documentation and key contacts.
The feasibility stage takes place once the research idea and the protocol have been developed. A detailed assessment of a range of factors must be considered before the College decides to continue, with attention paid to issues such as capacity, resources, equipment and funding.
At the work-up stage, work can begin on preparing the necessary documentation and initiating the approvals processes with internal support departments, such as pharmacy and imaging, and external bodies for ethics and regulatory checks. The submission to IRAS (SSI) triggers the 30-day clock for governance checks set by the NIHR.
The governance stage is where all the documentation and requests for approvals are scrutinised. The NIHR sets a target of 30 days for this, though the clock can be stopped when waiting for external approvals (eg REC may take up to 60 days), as long as all other internal checks have been made. When everything is in order, the Joint Research Compliance Office can issue Trust approval for the trial to proceed using NHS patients and/or facilities.
At the recruitment stage, the job of recruiting patients on to the study can begin. The NIHR sets a target of 30 days from R&D approval to the recruitment of the first patient. The trial is monitored up to the last visit of the last patient and closes once the findings have been collated, published and archived.