AE: Adverse Event – definition in slides
AI: Action Item – Pending tasks that need to be completed by the site staff or CRA.
CRA: Clinical Research Associate
CS and NCS: Clinical Significant and Not Clinical Significant – These are used to determine if a patient’s lab value is critical to be identified as an AE or not.
CTA: Clinical Trial Agreement – financial document between the site and the CRO/Sponsor detail payment and scope of work
CTMS: Clinical Trial Management System- A software where all clinical trial activities are operated. Most likely, visits will be scheduled in this system.
CV: Curriculum Vitae
DoA Log: Delegation Of Authority Log- Used to delegate tasks to several staff on the study.
ECG: Electrocardiogram – cardiology assessment
EDC: Electronic Data Capture- where data is entered
FDF: Financial Disclosure Form- required to declare financial interest in the company conducting the clinical trial.
FDA: Food and Drug Administration
GCP: Good Clinical Practice (certificates)
IB: Investigator Brochure – Safety profile of the compound
ICF: Informed Consent Form- required to gain from a subject prior to initiating and study-related activities.
ICH-GCP: International Council for Harmonisation – Good Clinical Practice, the governing body on how clinical trials should be conducted.
ID: Identification
IP: Investigational Product- The substance being tested.
IRB: Institutional Review Board- The institution charged with approving all items and documentation used in clinical trials
ISF: Investigational Site File, also called regulatory binder – holds all the regulator documents used to conduct the study.
IWRS: Interactive Web Response System- Used to randomize subjects and dispense study drugs.
ML: Medical License
PI: Principle Investigator- The leader of the clinical trial at the investigative site. Usually an MD or DO. They are typically responsible for ensuring the study is conducted according to the protocol.
SOP: Standard Operating Procedure- Set guidelines on how day to day operations should be carried out.
PHI: Patient Health Information- Any information that can be used to identify a patient. Protocol Deviation: Any violation or deviation from the protocol or protocol supporting documents
SAE: Serious Adverse Event – definition in slides
QC: Quality Control – ensuring the document meets ALCOA-C standards, where applicable