NCT03943017View on ClinicalTrials.gov

The Inspection Campaign of French Phase I/II Research Sites Following the BIA 10-2474 Accident

CompletedOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

January 1, 2017

Primary Completion Date

July 30, 2019

Study Completion Date

April 20, 2023

Conditions
Health Knowledge, Attitudes, PracticeSafety IssuesHealth, Subjective
Interventions
OTHER

Inspection and safety evaluation by 3 longstanding experience physicians of early clinical researches

Adjudicate each ARC's observations according to the 3 physicians perceived medical importance regarding safety; first, adjudications are performed separately. Then disagreements are settled during a final adjudication meeting between them.

Trial Locations (1)

75013

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM, Paris

All Listed Sponsors
lead

Groupe Hospitalier Pitie-Salpetriere

OTHER

NCT03943017 - The Inspection Campaign of French Phase I/II Research Sites Following the BIA 10-2474 Accident | Biotech Hunter | Biotech Hunter