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Table 6 Examples of monitoring findings

From: Generating evidence on a risk-based monitoring approach in the academic setting – lessons learned

Finding category Examples of findings
Administrative • Changes at the investigational site (staff training, staff CVs, address, technical equipment, etc.) not documented
• Functions and responsibilities log not up to date
• Subject related logs not up to date
• CRFs not available at site and/or not documented by authorized staff
Patient rights • Informed Consent Forms not signed and/or not dated correctly
• No valid and approved version of Informed Consent Form used
• Amendments/addenda to Informed Consent Form not communicated to patients and no re-consent obtained
• Patient did not fulfill all inclusion criteria
Patient safety • No description of the process for detecting and reporting serious and unexpected adverse events and/or unanticipated problems involving risk to participants in place at site
• Adverse events not correctly documented and/or reported as required (e.g. to Sponsor, EC, Competent Authority)
• New safety information not approved by authorities
• Staff not trained according to new safety information
Laboratory/Biological Specimen • Biological specimen not stored correctly according to protocol
• Process conducted not in accordance with Good Manufacturing Practice (GMP)
Data point confirmation requested • Indicates whether finding challenges the credibility of data point, e.g. by stating “Please confirm that blood pressure measure is 100/65 mmHg”
Data point changed • Indicates whether data point was adjusted as direct consequence of finding, e.g. “Blood pressure of 100/65 mmHg was corrected to 120/80 mmHg”
  1. CV Curriculum Vitae, CRF Case Report Form, EC Ethics Committee