R & D Overview
Research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention
Clinical Trial/Clinical Research
Some people call me the study Bible
Protocol
Discrepancy Management with Drug & Safety or Pharmacovigilance
SAE reconciliation
Once I have clean data, I --------- the forms or pages. I'm also called soft lock
Freeze
FPFV
First Patient First Visit
Post marketing surveillance
Phase IV clinical trial
I was built to collect, review and validate study data
EDC/Database
I let the team know the status of the study
Metrics(Weekly, Biweekly or monthly)
As a DM I ensure the CRA as performed --------- on targeted forms before soft lock
SDV(Source Document Verification)
LPLV
Last Patient Last Visit
The process of assigning patients by chance to groups that receive different treatments
Randomization
I'm the first meeting by the team when study protocol is approved
Kick Off Meeting(KOM)
I perform this when the site collects wrong data, missing data, incomplete data
Query the site
As I DM I make sure the PI has ------------ all reviewed and SDV'd forms before Soft or hard lock
Signed(called PI Signature)
DVS
Data Validation Specification
The processing, reviewing and validating Clinical Trial Data during a drug development or clinical trial
Data Management
I'm used to compile forms needed for the study
Schedule of Assessment/Time and Event Evaluation page/Schedule of Events
I review Conmed vs AE & Conmed vs Medical History.
Cross Panel Checks
Meetings are scheduled as needed with increased frequency to discuss urgent or non urgent issues
Adhoc meetings
EDC
Electronic Data Capture
I approve the protocol before Study can begin
IRB/FDA
The process of validating the integrity of the database
UAT
In order to make sure I follow query to resolution
Issues Log/Issues Tracker
I am the end of the study
DBL or closeout
CCG
eCRF Completion Guideline