A Clearer View of Clinical Research

For a principal investigator managing several clinical protocols, answering a simple question, such as “Which study needs attention today?” can mean checking multiple systems. The Clinical Research Dashboard from CRISPI brings key protocol information together in one place, giving investigators a clearer view of their studies and the work ahead.

The dashboard is part of Clinical Research Informatics Supporting Principal Investigators (CRISPI), NIH’s effort to make clinical research information easier to access and use across the Intramural Research Program. Now in beta testing, the dashboard is designed to help investigators move from a broad view of their protocols to the details behind a particular question, whether it concerns study startup, enrollment, scientific review, or reporting.

From a Portfolio View to the Next Action

When a principal investigator opens the PI dashboard, it automatically displays protocols for which they are listed as PI. They do not need to configure access to each protocol individually. From the home sheet, investigators can review their portfolio, look for trends, and select a protocol for closer examination.

The dashboard draws information from established NIH research systems, including PQS/Protrak, PROTECT, BTRIS, and NCI PINS. Its goal is to make information that may be spread across those systems easier to assess together. The protocol table also provides links to source records where available, so investigators can move from a summary to the underlying workspace when they need more detail.

Seven dashboard sheets support different questions. Protocol Demographics shows the composition of a PI’s studies, including enrollment by sex and race. Timeline to Protocol Initiation follows milestones from concept submission toward activation and first patient enrollment, helping teams see where startup may be slowing. Scientific Review Compliance highlights required reviews, with visual cues for items that are overdue or due soon. Two FDAAA sheets provide both a high-level view of reporting status and protocol-level details for investigating a specific issue.

These views can help a PI prepare for a study team meeting or decide where to follow up. An investigator could, for example, check approaching review dates, examine a protocol’s startup milestones, and then open its source record to confirm the next step. Filters for protocol number, title, PI, and study start date make it easier to narrow the view; selections carry across dashboard sheets. The protocol table can also be exported to Excel for further review.

Designed for the People Responsible for the Work

Access is based on a user’s role. PIs see the protocols assigned to them, while delegates can review assigned protocols on a PI’s behalf. Clinical directors have a broader view of protocols within their Institute or Center, supporting oversight of trends, bottlenecks, accrual, and compliance. This approach gives each user a view suited to their responsibilities.

The current beta testing period is an opportunity to make that view more useful. Participants are being asked to check whether the data associated with their work is accurate, whether the layout helps them find what they need, and to provide feedback on what additional data would be most valuable to you. Their feedback will help shape the dashboard as development continues. Investigators should check the “Data Last Updated” information shown on each sheet before using a figure in a report. During beta testing, PIs who do not see an expected protocol, notice a data issue, or have a suggestion can contact CRISPI Dashboard Support (odcrispidashboardsupport@mail.nih.gov).

The promise of the dashboard is practical: less time piecing together a picture of a study portfolio and more time identifying what needs attention. By making protocol information easier to see, explore, and act on, CRISPI aims to give investigators a stronger foundation for managing clinical research.