Clinical trial software for clinical research networks

Network studies often need a single ethics review to avoid repeating submissions at every site. In the United States, a single IRB is commonly required for federally funded multi-site research under NIH policy and the Common Rule cooperative research provision, with exceptions, and other countries have their own national models. Whatever the route, the coordinating centre needs a record of what was approved, which sites rely on it, and which version of the consent is in use. Capture helps with the consent version and the form lock: forms move from draft to approved, approved forms are locked for live use, and only approved forms appear in the casebook. The approvals file itself stays with your study documents.

Delegation of duties is a perennial inspection finding in multi-site research. Who is allowed to consent, who may enter data, who signs off as investigator. Capture uses role-based access, with researcher, site coordinator and admin roles, and investigators countersign consent with password re-authentication. Keep the delegation record in the delegation log template and the file index in the investigator site file index.

Training is the cost networks underestimate. Use the sandbox as the training environment: it has every feature, a coordinator can enter fake participants, trigger queries and sign forms, and nothing touches live data. The EDC UAT sandbox page explains how to use it for user acceptance testing before go-live.

Visiting every member site frequently is expensive and often unnecessary. Networks commonly combine central review of the data with targeted on-site checks. In Capture, edit checks flag impossible values at entry, auto-queries go to the site when a rule is broken, and source data verification can be set per field so monitors verify what matters for eligibility, safety and the primary endpoint. The risk-based monitoring page explains the approach and the query management page shows how queries are raised and resolved.

Look at the patterns by site. A site with a long list of open queries, late visits or a high rate of protocol deviations often needs support rather than blame, and a coordinating centre that sees this early can retrain before a pattern becomes a finding. Keep the monitoring visit report template for on-site checks, and use by-site exports to compare sites on the measures you agreed in advance.

For safety, adverse events and serious events are captured on standard forms at every site, with severity, seriousness and relationship as separate answers. The network’s safety lead sees the same record as the site. Reporting timelines depend on the protocol and local regulation; the SAE deadline calculator can help plan, and the decision stays with the responsible people.