Management and reporting

Trials not only require clinical and methodological know-how, they also require trial management expertise. Successful clinical trial management and reporting requires meticulous planning to develop a comprehensive strategy that includes trial timelines, milestones, knowledge of reporting requirements and resource allocation.

A clinical trial needs to maintain open and transparent communication with all stakeholders, including sponsors, investigators, participants, and regulatory bodies.

During the trial, there are a number of management and reporting tasks that need to be overseen; these are:

Budget management

• Vendor invoicing and tracking payments.
• Participant payments.
• Maintenance of your study budget.

Milestone tracking

• If milestones are not achieved, take necessary actions, e.g. recruitment is behind, implement mediation strategies as per the recruitment plan.

Regulatory compliance

• Keeping the trial master file and/or site file up to date 
• Ongoing filing of study records and documents.
• Review clinical trial methods and provide internal quality assurance.
• When applicable, conducting site initiation visits for clinical trial locations and completing any necessary training activities.
• Ensuring data quality and adherence to any relevant data regulations.

Communication management

• Regular meetings with the trial team (PI oversight meetings).
• Hold Trial Steering Committee (TSC) meetings and, where applicable Data Safety Monitoring Boards (DSMB).
• Ensure staff are kept up-to-date with knowledge of relevant industry guidelines, such as health and safety, data protection or human tissue handling regulations.

Reporting 

• Conduct regular reviews of clinical trial data in adherence with the data management plan.
• Follow institutional and ethical guidelines for reporting requirements (e.g. annual reporting, safety reporting). 
• Handling any medical issues or other adverse events among trial participants, ensuring they report and record details of such an event.