DSMB
What is the Data and Safety Monitoring Board?
A original record of event
what is source documentation?
smp_aca_acp_103_046@worldwide.com
What is WCT study email mailbox?
TEAE
Treatment Emergent Adverse Event
A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s).
What is masking/ blinding?
Is a male or female ≥60 years of age
What is the age inclusion criteria?
Tori Pratola
What is the ACADIA contact for Veeva Vault TMF?
15°C to 30°C (59°F to 86°F)
what is the required storage condition for IP?
what is the turn around time for B12 reports from ICON?
4 days
This process must occur before any study related activities occur with a potential participant (unless waived or altered by the IRB).
What is the informed consent discussion and signing of the informed consent document?
citalopram
escitalopram
venlafaxine
what are the restricted medication for ACP-103-046 study?
CL0035-F1
What is Medical Monitor Assessment of Eligibility Criteria and Prohibited Medication Deviations?
CPHS
What is the Committee for the Protection of Human Subjects?
Documentation that allows reconstruction of the course of events
What is definition of Audit Trail?
TEAE
what is the primary measure for this study?
notify 24 hours prior to this
What is the timeline to notify ERT 24 hours prior to Randomization visit?