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Dokumente

Case report forms>20
Clinical overviews / clinical expert reports>25
Clinical study reports, full>50
Clinical study reports, abbreviated>10
Clinical study protocols>40
Clinical summaries>20
IND annual reports4
Investigator brochures4
OOS Gutachten3
Periodic safety update reports (PSUR)3
PRAC Gutachten2
Response to deficiency letters>10
Risk management plans2
Publications>45
Standard operating procedures>30