Author: S. Eric Ceh, DPM, CCRA, is President of SEC Clinical Consulting, a provider of monitoring, quality assurance, and project management services.
For each site, create a Site Summary that lists IRB activities, site personnel information (CVs, licenses and training), lab certificates, study drug/device receipts, notes to file, correspondence, and other documents typically found in a regulatory binder. Use this document during visits to identify and address site regulatory issues. Between visits, update the document based on communications from the site of IRB actions and other pertinent developments.
Create a Subject Summary (also known as monitoring notes) for each of your sites’ study participants. This document is mainly used by the monitor to track the extent of monitoring and key data points. It can be shared with site or project management for clarification purposes.
Subject Summary contents vary by study, but usually include the activities listed in the protocol timetable. After arriving at a site, populate this document from source documents before reviewing the case report forms (CRFs). Once you begin reviewing the CRFs, highlight the data points you listed on the Subject Summary that were missed or incorrectly entered by the site that need to be queried, along with observed deficiencies that can be included in the visit report and/or post visit letter.
Use the Subject Summary to facilitate the generation of effective queries and informative findings. When writing a query, whenever possible, use your Subject Summary notes to identify the data point and corresponding source document in question so the issue is clearly presented, e.g., “The medical history included excess bleeding per the pre-op note dated 6/17/13. Please confirm to add this condition to the subject history.” Refer to the Subject Summary and attached documents when writing the Visit Report, e.g., the extent of the review during a visit and findings like adverse events, deviations, source document issues, and drug/device accountability. This tool enables a quick response to project management inquiries about a subject.
For studies that use electronic database capture (EDC), review the database entries prior to a site visit and populate the Subject Summaries. Upon arriving at a site, first review the source documentation and update the Subject Summaries, and then monitor the data in the EDC system.
For more site monitoring tips, see S. Eric Ceh’s article, “Lessons Learned from 20 Years as a Site Monitor,” in the Journal of Clinical Research Best Practices".
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