Recruitment Phase

Progress Reporting follows the Safety Reporting station and precedes the MHRA Inspection station. This process occurs in parallel with Safety Reporting, Ongoing Management & Monitoring, and GCP & Serious Breach Reporting. It also has the potential to occur simultaneously with an MHRA Inspection, Audit, Substantial Amendments, Addition of New Sites & Investigators, Urgent Safety Measures, Temporary Halt, and Early Termination. Progress Reporting is good practice and is relevant to all trials. This station is part of the ‘recruitment phase’ group of stations.

There is a requirement to send progress reports to a number of interested parties throughout a trial. For example, Trial Steering Committees and Funders will require regular updates and routine reports.

Performance monitoring is a key part of the NIHR Clinical Research Network Study Support Service. A collaborative project has developed a single ‘minimum data set’ that reflects the new HRA Approval processes.  The NIHR Guidance: Minimum data set for the Performance in Initiating and Delivering Clinical Research provides further information.

An annual progress report is also sent to the ethics committee. The HRA website provides a specific Annual Progress Report Template for CTIMPs relating to completion and submission of this report. In addition, progress reports are usually required by the trial sponsor and the NHS R&D Office(s) where the trial is conducted.

Further reading: