'Sae report' diaporamas de présentation

Categories include:

The most ambitious, prolific and progressive software solution available for Clinical Trails is a customized, complete, end-to-end, EDC / CTMS / Randomization Plus application aptly named Simplicity .

687 views • 59 slides

Categories include:

The most ambitious, prolific and progressive software solution available for Clinical Trails is a customized, complete, end-to-end, EDC / CTMS / Randomization Plus application aptly named Simplicity .

596 views • 59 slides

586 views • 30 slides

316 views • 30 slides

Handling and reconciliation of SAE data: a CRO perspective

Gerald Ruiter, Senior Data Manager & Drug Safety Officer IATEC BV, Amsterdam, The Netherlands. Handling and reconciliation of SAE data: a CRO perspective. Position of CRO:. Different clients with different specific requirements regarding handling and reconciliation of SAE Data:

450 views • 27 slides

SAEs and IND Safety Reports

SAEs and IND Safety Reports. When to report to the IRB. Is it Serious? (death, disability, incapacity, hospitalization (initial/prolonged), required intervention to prevent permanent impairment). Is it Unanticipated? (not listed in protocol/informed consent form). Event is an AE; not SAE

29 views • 2 slides