Abbreviations
GCP
Site Related
Protocol
Miscell
100

DSMB

What is the Data and Safety Monitoring Board?

100

A original record of event

what is source documentation?

100
The buck stops here
Who is the principal investigator?
100
C-GAS scale to be completed
When should C-GAS should be completed?
100

smp_aca_acp_103_046@worldwide.com

What is WCT study email mailbox?

200

TEAE

Treatment Emergent Adverse Event

200

A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s).

What is masking/ blinding?

200
a process in which researcher (or appropriately trained designee) discloses all relevant information about a study, a potential subject has opportunity to ask questions, and researcher answers questions.
What is the informed consent process?
200

Is a male or female ≥60 years of age

What is the age inclusion criteria?

200

Tori Pratola

What is the ACADIA contact for Veeva Vault TMF?

300
IND
What is Investigational New Drug?
300
This report describes respect, beneficence and justice as key components of clinical research on humans subjects.
What is the Belmont Report?
300
High enrolling site
What is a reason for an FDA audit?
300

15°C to 30°C (59°F to 86°F)

what is the required storage condition for IP?

300

what is the turn around time for B12 reports from ICON?

4 days

400
HIPAA
What is the Health Insurance Portability and Accountability Act?
400
Graphic display of schedule of activities/visits in a research protocol.
What is the schema of events?
400

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?

400

citalopram

escitalopram

venlafaxine

what are the restricted medication for ACP-103-046 study?

400

CL0035-F1

What is Medical Monitor Assessment of Eligibility Criteria and Prohibited Medication Deviations?

500

CPHS

What is the Committee for the Protection of Human Subjects?

500

Documentation that allows reconstruction of the course of events

What is definition of Audit Trail?

500
This provides public assurance that the rights, safety and well-being of human subjects involved in research are protected.
What is GCP compliance?
500

TEAE

 what is the primary measure for this study?

500

notify 24 hours prior to this

What is the timeline to notify ERT 24 hours prior to Randomization visit?

M
e
n
u