Dividing a project into stages makes it possible to lead it in the best possible direction. Through this organization into stages, the total workload of a project is divided into smaller components, thus making it easier to monitor. The following paragraphs describe a staging model that has been useful in practice. It includes eight stages:
Stage 1 : Initial Stage
Stage 2 : Identification Stage
Stage 3 : Critical Analysis Stage
Stage 4 : Structuring Stage
Stage 5 : Project Development Stage
Stage 6 : Execution Stage
Stage 7 : Maintenance Stage
Stage 8 : Ongoing Management Stage
Stage Eight
Ongoing Management Stage
Think before you act is at the heart of the Eight Stage model. Each stage has its own work package. Each work package has its own aspects that should be the focus of concentration. It is therefore unnecessary to continue discussing what is to be made during the Execution Stage. If all has gone well, this was already determined in the Identification Stage and the Structuring Stage.
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 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 communicat ed to all investigators.