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. 2020 Jul 22;38(34):5490–5497. doi: 10.1016/j.vaccine.2020.06.016

Table 1.

Overall pooled number of responses per category area.

Pharmacovigilance Activity per Category Number of questions per category Pooled number of YES answers per category Pooled number of NO answers per category Pooled number of answers YES + NO Percentage of YES/total
Organizational Structure relating to PV 12 259 149 408 63%
AEFI collection from passive reporting 8 171 101 272 63%
AEFI collection from active reporting 9 198 108 306 65%
Management of AEFI 5 132 38 170 78%
Management of Aggregate Reporting 5 118 52 170 69%
Safety Database System 9 124 182 306 41%
PV Quality Management System 8 207 65 272 76%
Safety Signal and Risk Management, and Communication 8 160 112 272 59%
Safety Data Exchange Agreements 3 73 29 102 72%
Total 67 1442 836 2278 63%

This table displays the survey results of the nine PV key activities assessed: The first column indicates the nine different PV key categories; the second column shows the number of questions per category; the third column, the total number of YES responses reported per category, indicating that the respective activities and processes are performed (without any further specification on the level of implementation); the forth column, the total number of NO responses reported per category, indicating that the respective activities/processes are not performed; the fifth column shows the total number of all responses (YES and NO) per category; and the sixth column displays the percentage of YES responses per category.