GCP
According to the principles of ICH GCP, this is the most important consideration when conducting a clinical trial.
protection of trial subjects
Name of our Safety database.
Argus
If it is not __________, it did not occur.
Documented
Trial Master File
IRNOMFED CNESONT
INFORMED CONSENT
The only individual at the site designated to delegate authority.
Principal Investigator
Upon awareness of an SAE, site to inform sponsor by this turnaround time.
24 hours
All Quality Events, Deviations, and Complaints are to be reported and tracked in this system.
Veeva eQMS
CRF
Case Report Form
SIRUOES VERAESD ENVTE
The original document where data is captured (labs, site documents, etc) and needed to validate the CRF
Source Documentation
SAE Reconciliation to occur at minimum by this frequency.
Monthly
Internal document tool designed to capture study events and process overviews to aid teams during an inspection. Typically not share with an inspector.
Study Storyboard
ICF
Informed Consent Form
CLAOCINPME
COMPLIANCE
Enrolling a subject that does not meet one inclusion critieria.
Protocol Deviation
This field was added to BeiGene standard Adverse Event CRF as a result from an inspection finding.
SAE Site Awareness Date
System used to during inspections to monitor progress and track documentation requests.
Auditutopia
SDTM
Study Data Tabulation Model
SDSG AHDE OIEFCF
ICH guidelines are divided into 4 categories: Quality Guidelines, Efficacy Guidelines, Safety Guidelines and _________.
Multidisciplinary Guidelines
Document that provides safety data and findings from interventional clinical trials of drugs and biologicals that are under investigation, whether or not they have a marking approval. This is document is produced once per year.
Development Safety Update Report (DSUR)
All submission documents are filed in this system.
Veeva BRIM
ALCOA
Attributable, Legible, Contemporaneous, Original, Accurate
PTSENTIA FTIRS
PATIENTS FIRST