Table 6 Examples of monitoring 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”