Medicinal Products
GCP Metrics
During 2022, 17 GCP supervisions of clinical trials were implemented in the same number of healthcare institutions/investigational sites.
- Defined KPI for 2022 in Agency: Number of planned GCP supervisions in the current year – at least 12
Implementation: >100%
All GCP supervisions implemented in 2022 are routine supervisions of trial site (investigational sites) in healthcare institutions, and were conducted remotely due to the conditions of the COVID 19 pandemic. The Agency conducts supervisions in accordance with local regulations, international regulations and its own procedures. During the supervisions, data integrity and patient safety of subjects in clinical trials are checked.
Categorisation of the findings
- A) General Overview
A total of 169 findings were identified across the 17 sites supervised, including 27 Critical findings, 32 Major findings, 110 Minor findings and 62 Opservations. This represents an average of 10 findings per site supervised. The main findings observed in 2022 are detailed below in accordance with the GCP findings categorisation.
Table 1. Number of findings – Critical, Major, Minor
Figure 1. Number of findings – Critical, Major, Minor
b) Distribution by category
Table 2: Number of findings by main categories and severity of findings
Figure 2: Number of findings by main categories and severity of findings
c) Distribution by sub-categorie
Table 3: Number of findings by sub-categories and by degree of findings
Figure 3: Number of findings by sub-categories and by degree of findings
Finally, Table 4 shows the distribution of responsibilities for each grading of finding.
Table 4: Responsibility for findings, Summary
Table 5. Investigator’s responsibility regarding sub-category findings
Figure 4. Investigator’s responsibility regarding sub-category findings
Table 6. Sponsor’s responsibility regarding sub-category findings
Figure 5. Sponsor’s responsibility regarding sub-category findings
Table 7. Findings regarding shared responsibility between sponsors and investigators
Figure 6. Findings regarding shared responsibility between sponsors and investigators
During 2023, 22 GCP supervisions of clinical trials were implemented in the same number of healthcare institutions/investigational sites.
- Defined KPI for 2023 in Agency: Number of planned GCP supervisions in the current year – at least 20
Implementation: >100%
All GCP supervisions implemented in 2023 are supervisions of trial site (investigational sites) in healthcare institutions. During the first quarter of 2023, due to the conditions of the COVID19 pandemic, 6 GCP supervisions were conducted “remotely“, the remaining 16 were conducted in (at investigational sites) in healthcare institutions. The Agency conducts supervisions in accordance with local regulations, international regulations and its own procedures. During the supervision, data integrity and patient safety of subjects in clinical trials are checked.
Of the total of 22 GCP supervisions conducted, 20 were routine and 2 were triggered by the Agency’s Clinical Trials Department.
- A) General Overview
A total of 124 findings were identified across the 22 sites supervised, including 12 Critical findings, 25 Major findings, 87 Minor findings and 32 Opservations. This represents an average of 6 findings per site inspected. The main findings observed in 2023 are detailed below in accordance with the GCP findings categorisation.
Table 1. Number of findings – Critical, Major, Minor
Figure 1. Number of findings – Critical, Major, Minor
b) Distribution by category
Table 2: Number of findings by main categories and severity of findings
Figure 2: Number of findings by main categories and severity of findings
c) Distribution by sub-categories
Table 3: Number of findings by sub-categories and by degree of findings
Figure 3: Number of findings by sub-categories and by degree of findings
Finally, Table 4 shows the distribution of responsibilities for each grading of finding.
Table 4: Responsibility for findings, Summary
Table 5. Investigator’s responsibility regarding sub-category findings
Figure 4. Investigator’s responsibility regarding sub-category findings
Table 6. Sponsor’s responsibility regarding sub-category findingsž
Figure 5. Sponsor’s responsibility regarding sub-category findings
Table 7. Findings regarding shared responsibility between sponsors and investigators
Figure 6. Findings regarding shared responsibility between sponsors and investigators
During 2024, 19 GCP supervisions of clinical trials were implemented in the same number of healthcare institutions/investigational sites.
- Defined KPI for 2024 in Agency: Number of planned GCP supervisions in the current year – at least 20
Implementation: 95% achieved
All GCP supervisions implemented in 2024 are supervision of trial site (investigational sites) in healthcare institutions. The Agency conducts supervision in accordance with local regulations, international regulations and its own procedures. During the GCP supervision, data integrity and patient safety of subjects in clinical trials are checked.
Categorisation of findings
- A) General Overview
A total of 93 findings were identified across the 19 sites supervised, including 8 Major findings, 85 Minor findings and 29 Observations. This represents an average of 5 findings per site supervised. The main findings observed in 2024 are detailed below in accordance with the GCP findings categorisation.
Table 1. Number of findings – Critical, Major, Minor
Figure 1. Number of findings – Critical, Major, Minor
b) Distribution by category
Table 2: Number of findings by main categories and severity of findings
Figure 2: Number of findings by main categories and severity of findings
c) Distribution by sub-categories
Table 3: Number of findings by sub-categories and by degree of findings
Figure 3: Number of findings by sub-categories and by degree of findings
Finally, Table 4 shows the distribution of responsibilities for each grading of finding.
Table 4: Responsibility of findings, Summary
Table 5. Investigator’s responsibility regarding sub-category findings
Figure 5. Investigator’s responsibility regarding sub-category findings
Table 6. Sponsor’s responsibility regarding sub-category findings
Figure 5. Sponsor’s responsibility regarding sub-category findings
Table 7. Findings regarding shared responsibility between sponsors and investigators
Figure 6. Findings regarding shared responsibility between sponsors and investigators