Common Research/OnCore Acronyms

CRA: Clinical Research Associate, a title used by both monitors, sponsors alike.
CRBS: Clinical Research Billing Support
CRC: Clinical Research Coordinator, a title used to refer to the Clinic personnel here at WashU.
CRO: Clinical Research Organization, a blanket term for the companies that monitors generally work for. A few examples: IQVIA, Covance, and Prahs.
CR: Continuing renewal, the approval from the IRB that allows a study to remain open. Occurs on an annual or tri-annual schedule, depending on the study.
HRPO: (Human Research Protection Office) HRPO provides support for the IRB review process and performs administrative functions as they relate to IRB responsibilities and oversight. HRPO also serves as a resource to the research community including those conducting research and those volunteering as research participants.
IB: Investigator Brochure, a document that details information about the study drug for the investigator’s knowledge.
ICF: Informed Consent Form,(also just referred to as a ‘consent’),this is the document a subject signs that allows them to participate in a trial.
IND: Investigational Drug, also called IP (Investigational Product)or study drug. These are drugs in use in clinical trials that have not yet obtained FDA approval. You might also hear people say things like, “Is it under an IND?” meaning the drug is being used in accordance with federal regulations.
IDE: Investigational Device. Same as above, except with a device, rather than a drug.
IRB (Institutional Review Board): reviews and oversees research involving humans.
- IRBs can either be internal (WashU) or external. WashU’s IRB is called HRPO (Human Research Protection Office)and some common external IRBs are Advarra and WIRB (Western IRB).In most cases when an external IRB is used, all sites, including other external sites, will utilize the *same* external IRB.
Mod: Short for ‘modification,’ a type of submission to the myIRB system that occurs when the sponsor releases a protocol amendment, or when another change is needed (e.g.;to the study team)
OST: Oncore Support Team
PI: Principal Investigator
PRMC (Protocol Review and Monitoring Committee): reviews cancer-related studies to ensure they are scientifically and statistically sound.
QASM: Quality Assurance and Safety Monitoring, used as an independent monitoring committee on data and safety for investigator-initiated studies.