Recruitment

Ongoing Management & Monitoring follows the Progress Reporting station and precedes the GCP & Serious Breach Reporting station. This process occurs in parallel with Safety Reporting, Progress Reporting, 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. Ongoing Management & Monitoring is a legal requirement which is relevant to all trials. It is grouped within the recruitment category.

The expectation of the sponsor to develop appropriate trial management plans is outlined in the Trial Management & Monitoring station.

As the trial progresses, the sponsor must oversee its management and ensure that management strategies are adhered to. It is important, for example, to ensure that the monitoring performed for a particular trial, is in accordance with its monitoring plan. In addition, investigators must comply with the sponsor’s instructions and study procedures.

The sponsor will re-appraise trial management strategies, clinical monitoring plans and quality assurance measures at necessary intervals and in response to events such a serious breach of GCP/protocol or a substantial amendment to the protocol. The sponsor will ensure that any changes are implemented in a timely fashion and where applicable, are communicated to all investigators.

Further reading & Workstream Documents: