Progress Reporting
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.
Progress Reports
Sponsors should ensure that arrangements are in place for reporting trial progress throughout the life of the study. Progress reports support ongoing oversight, enable early identification of issues, and provide assurance that the trial remains scientifically and ethically appropriate.
Many stakeholders will require updates at defined intervals. These commonly include Trial Steering Committees, Data Monitoring Committees, funders, sponsors, and NHS R&D Offices (or equivalent governance bodies) at each participating site.
Annual progress reports are not routinely required for submission to the Research Ethics Committee (REC).
For research funded by the National Institute for Health and Care Research (NIHR), regular progress reports are required in line with funding agreements. Reporting milestones are typically project-specific and may be linked to key deliverables such as recruitment targets, data quality, timelines, and dissemination plans. These reports enable NIHR to assess progress and provide support where needed.
Further Reading
- NIHR: Tools and support to monitor study progress.