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Documents
 | 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 expertises | 3 |
| Periodic safety update reports (PSUR) | 3 |
| PRAC expertises | 2 |
| Publications | >45 |
| Response to deficiency letters | >15 |
| Risk management plans | 2 |
| Standard operating procedures | >30 |
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