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” |