Challenge

Clinical studies generally occur within active clinics that see many patients daily. With the hustle and bustle of routine care, it is difficult to keep tabs on things like incoming labs and schedules for follow up visits. The ideal solution is to have access to an electronic data capture system that provides automatic notifications for a variety of events such as incoming labs, follow up calls, new queries, resolved queries, and any other notifications deemed helpful.

Additionally, Sponsors and CROs located outside of clinics have had to rely on updates and communication from the clinical sites via phone or email, making it difficult to keep tabs on the study’s progress. Furthermore, time lag between data collection and queries made of the data can diminish the reliability and validity of the data collected. For paper-based studies, this time lag generally occurs between the time the data is collected, entered into a spreadsheet and emailed or mailed to Monitors. In this case, the Sponsor wanted the Monitor to be able to query the data and receive a response.

Proposal

Prelude Dynamics proposed to use VISION™, an electronic data collection system, to accurately capture real-time study data and apply features to address the Sponsor’s time-lag and query concerns. VISION™ contains a variety of features that allow better communication between site personnel and monitoring staff, including the ability to attach a query directly to a field; make a comment directly to a field to add details, clarify information, or create a note to file attached to that particular field; send notifications within the system to specific roles or all study staff; and program customized automated notifications. The system provides a summary table of the comments/notes and queries for quick review and response.

In addition to these features, the system also contains administrative forms, such as note-to-file and deviation forms at the patient, site and study level; a visit log to track site visits and record general information about these visits, including allowing a report to be uploaded to the system; and similarly, a communication log to capture general communication information and upload reports to the system, including a place for the other party involved in the communication to agree with the information. Another optional module is available that allows protocol and protocol amendments to be uploaded in the system and tracked. Training logs, paperwork on study personnel, and additional documents can also be stored in the VISION™ system by using the optional modules.

VISION™’s custom notifications feature was implemented to address the Sponsor’s needs for prompt response to study activities, including:

  • When lab draws are made and shipment information entered, the lab receives an email that specimens are in route to be analyzed.
  • When lab data was received with errors, the lab personnel, project manager and monitor receive an email.
  • When lab results are uploaded into VISION™, site personnel receives an email.
  • When a patient is successfully randomized and enrolled into the study, the monitor and project manager receive an email.
  • When a patient is withdrawn from the study, the monitor and project manager receive an email.
  • When a serious adverse event has occurred, the monitor and project manager (or other designated roles) receive a notification.
  • When a query is entered into VISION, appropriate site personnel receive an email.
  • When a query is resolved by site personnel, the project manager and monitor receive an email.
  • When feedback is put into VISION, the project management staff at Prelude Dynamics is notified that there is pending feedback.
  • When results on a scale are outside of a given range, the monitor is notified.
  • When drug inventory is low (as indicated by a preset threshold), VISION™ automatically calculates the amount needed and generates an email to order additional drugs.

Any notifications sent by VISION are tracked so there is an audit trail of when the notification was sent (date/time stamp), who it was sent to, and if it failed to send.

Background

Clinical studies collecting data on paper require the site personnel to either enter the data into a spreadsheet or to send the paper copies to data entry personnel in order to be input electronically before being sent to the study Monitor to review. The time from data collection to data review was at best a couple of days, which affected the reliability and validity of queried data. Additionally, site staff reviewing the data were generally limited to only the information they collected at the time of the interaction with the patient. Any data that was not filled in completely or correctly could become lost or compromised, possibly resulting in elimination of a case from the study.

Site and monitoring personnel have typically communicated via phone or email. However, all parties did not necessarily have access to the same data at the same time, limiting the data discussion. Further, in a busy clinic with high patient volume, it was difficult for staff to promptly respond to emails and phone messages. Automatic email notifications for specific events (unresolved queries, lab results received, etc.) contributes to the outcome of the study in that it allows site staff to directly access the pertinent information without searching through the system to find the information, in turn, allowing staff additional time to make follow up calls.