Using Workflow to Manage Study Startup

InfoEd’s Clinical Trials module features highly flexible workflow administration tools that can be used to manage the various internal approvals and other steps that make up the study startup process. The starting point for these configurations is the creation of statuses that reflect all of the stages a trial will move through, from startup to completion. These statuses and their sequencing are fully controlled by the institution.

No single list of statuses will suit every institution. There is also no “right” level of detail, although it can be helpful to log a status change each time a record is transferred from one person (or office) to another, or for each item that needs to be checked off during study startup (such as billing plan review, execution of the contract, site initiation, etc.). This enables the creation of detailed workflow maps that show how many trial records are at each step, and where delays or bottlenecks might be occurring.

User roles also need to be created to reflect the different functions users perform with respect to clinical trials, from startup to closeout. Establishing appropriate workflow permissions for each role will ensure that each person has the information they need to perform their assigned tasks. Access is managed separately for trials, accounts and participant data, allowing for clear separation between administrative and operational functions.

Building from the list of trial statuses, workflow rules can be set up to enforce completion of required steps in the desired order. In this example, a newly created trial cannot be opened to enrollment until the administrative and IRB review steps are marked complete.


Each status can also have one or more roles mapped to it. Several different assignment types are supported, allowing for automatic or manual assignments as status changes are recorded. Each time a record moves into a new status, the user(s) responsible for that step will receive an action item with the subject line and instructions configured by the workflow administrator.

Workflow can also be set up for adverse events, clinical trial agreements and accounts. Although the details for those items will be different, the configuration process is essentially the same. If you would like more information, please submit an information request form.

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