The Study Life Cycle is the central concept in the quality system of Promasys. It is a logical division of a clinical trial in a number of well defined phases. Through the implementation of the Study Life Cycle, Promasys superimposes a quality system on its data management and workflow functionality, that supports your organization to comply with GCP and other relevant regulations. However, Promasys does this in a way that follows the natural order of a clinical trial and therefore minimally interferes with an efficient conduct of the trial.

Within a phase, a user has the maximum level of freedom that belongs to his/her role in the organization, as laid down in the access rights and group membership of the user. The change of one phase to another is centrally controlled, to ensure quality controlled, GCP compliant execution of the trial.

A typical example is that a study manager or investigator during the definition phase of the trial has the freedom to make changes to the trial design. But when the trial is approved by the Ethics Committee and Regulatory Authorities, the desing is frozen and the same investigator no longer can make any changes. Whenever changes need to be made to the design, for instance in the case of protocol amendments, these can only be made by a person with special access rights, following a special procedure. And of course, all these actions are recorded in the Promasys audit trail.

The Study Life Cycle starts with the Definition phase, followed by the Approval phase during which the design is locked in anticipation of EC and RA approval. Depending on the outcome of the ethical and regulatory review, the trial is either moved backed to the Definition phase to make required adaptations, or moved forward to the Execution phase.

The Execution phase is the "clinical" phase: subjects are recruited and screened and enlisted into the trial to undergo the defined treatment or observation. The measurements result in the cinical trial data that are stored in the database. The next phase is the Data Entry phase: no more subjects are recruited and all treatments or observations are completed. Still data is coming in, typically from lab analyses and these data are stored in the database.

After completion of all data entry and data cleaing activities, the trial moves forward to the Analysis phase. The data are locked and (in case of double blind studies) treatments become visible. The trial data are now available for statistical analysis. The last two phases of the Study Life Cycle are the Finalization phase for administrative wrap up of the trial, and the End phase. The trial is now completed, the design and all data are frozen, but remain always available and accessible for regulatory and scientific review.

If you want to read more about the phases of the Study Life Cycle, please click on one the following link .