|  |  | 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 reports | 4 |  |  | Investigator brochures | 4 |  |  | OOS Gutachten | 3 |  |  | Periodic safety update reports (PSUR) | 3 |  |  | PRAC Gutachten | 2 |  |  | Response to deficiency letters | >10 |  |  | Risk management plans | 2 |  |  | Publications | >45 |  |  | Standard operating procedures | >30 |  |  |