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Site Monitoring Goes High Tech with On and Off Line CTMS Forms

BioCure Monitoring Trip Report

Do you still carry a briefcase full of paper? Are you lost without an internet connection? Hopefully, you have embraced technology and answered "No" and "Yes" to those questions.

Here in 2012, most clinical studies use electronic data collection (EDC). The use of Clinical Trial Management Systems (CTMS) to perform site management and keep track of study regulatory documents, monitoring visits and study budgets has been significantly on the rise over the past few years. Using paper envelopes to randomize is almost extinct and study monitors are finally ready to part with their big suitcase of highlighters, black pens, 3-part NCR forms, and yellow sticky notes.

The following list of tasks were all previously done on spreadsheets or paper and are now done electronically:

  • Identification and selection of investigators
  • Identification and management of central institutional review boards
  • Regulatory document review and collection for site qualification, initiation, and closeout)
  • Site contract, budget negotiation, and grant administration
  • Training
  • Interim site monitoring
  • Drug accountability
  • Secondary clinical review
  • Data query resolution

The biggest challenge to EDC is the need for an internet connection. However, with new advances from BioClinica, monitors can now do everything electronically without logging into the CTMS! This significantly cuts down on transcription errors and makes their information accessible to the rest of the study team immediately. This allows us to do up-to-the-minute status updates for study dates, regulatory documents, action items and, budgets.

BioClinica is offering our OnPoint CTMS customers an option for monitors to access the data needed for their monitoring visits in a variety of ways. The most straightforward way is to use Microsoft technologies to obtain and populate the form with data from the CTMS and generate the custom monitoring visit report based on the actual information needed. For example, the report will list site specific current action items for this visit, display the regulatory documents that have not yet been obtained, show the subject status that is used for payments to the sites, and list any protocol deviations reported. Using this type of 'smart' technology gives the study monitor more time to spend with the site personnel reviewing important protocol procedures and outcomes.

The data from these 'smart forms' are synced with SharePoint, which will update OnPoint CTMS – all without having to login!


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