Progress Reporting follows the Safety Reporting station and precedes the Ongoing Management & Monitoring 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.
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.