City slang

Last reviewed October 14, 2026

The words you will hear in clinical research, each in one plain sentence.

#

1572: The FDA form where a US investigator commits to follow the rules for a study.; Ask the city about this

A

Advisory board: A paid meeting where experts give the company advice.; The Exchange Ask the city about this
AE: Adverse event. Anything bad that happens to a patient during the study, related or not.; The Clinic Ask the city about this
ALCOA: Attributable, legible, contemporaneous, original and accurate: the test for good records.; Ask the city about this
Aliquot: A sample split into smaller tubes.; Central Lab Ask the city about this
Amendment: A change to the protocol or consent that needs approval first.; Reg House Ask the city about this
Audit trail: The record of who changed what in a system, and when.; Ask the city about this

B

Backfill: Hiring someone to replace a person who left.; Careers Corner Ask the city about this
Bill rate: What a client pays per hour for a contractor.; Careers Corner Ask the city about this

C

CAPA: Corrective and preventive action: the fix for a problem plus the change that stops it happening again.; Ask the city about this
Causality: The doctor's call on whether the study drug could have caused a problem.; The Clinic Ask the city about this
CDISC: Shared formats for study data so regulators can read it the same way every time.; Data Works Ask the city about this
Central lab: One lab that tests samples from every site, so results compare.; Central Lab Ask the city about this
Central monitoring: Reviewing study data from the office to spot problems across sites.; Ask the city about this
Chain of custody: The record of who held a sample and when, from arm to lab.; Home Visit Hub Central Lab Ask the city about this
Change order: A formal change to the scope and budget of a contract.; Project Tower Ask the city about this
Close-out: The last visit, when the study ends at that site.; Terminal C Ask the city about this
CRF: Case report form: the set of questions the study collects for each patient.; Data Works Ask the city about this
CTA: Clinical trial application: the request to a regulator outside the US to run a study.; Reg House Ask the city about this
CTIS: The EU portal where trial applications now go.; Reg House Ask the city about this
CTMS: Clinical trial management system: where a study team tracks sites, visits and milestones.; Ask the city about this

D

Data cleaning: Finding and fixing wrong or missing data before lock.; Data Works Ask the city about this
Day 0: The day anyone at the company first learns of a safety case, which starts the reporting clock.; Safety Watch Ask the city about this
DBL: Database lock. When the data is frozen so it can be analysed.; Project Tower Ask the city about this
DCT: Decentralized trial. A study where some or all visits happen away from the site.; Home Visit Hub Ask the city about this
Delegation log: The list of who at the site may do which study task, signed by the PI.; Site 204 Ask the city about this
Deviation: Anything done differently from what the protocol says.; Site 204 Ask the city about this
Direct to patient: Study drug shipped from a pharmacy straight to the patient's home.; Home Visit Hub Ask the city about this
DSMB: Data safety monitoring board: independent experts who look at unblinded results to protect patients.; Ask the city about this
DSUR: Development safety update report: the yearly safety summary for a drug in development.; Safety Watch Ask the city about this

E

eCOA: Questionnaires and diaries patients fill in on a phone or tablet.; Home Visit Hub Ask the city about this
eConsent: Consent done on a screen, sometimes with a video call.; Home Visit Hub Ask the city about this
eCRF: The electronic case report form inside the EDC.; Ask the city about this
EDC: Electronic data capture: the system where sites enter study data.; Data Works Ask the city about this
Edit check: An automatic rule in the EDC that flags data that looks wrong.; Data Works Ask the city about this
Eligibility: The rules that say who can join the study and who cannot.; The Clinic Ask the city about this
Escalation: Raising a problem to someone more senior when it cannot be solved where it is.; Terminal C Ask the city about this
Essential documents: The papers that show the study was run properly, listed in GCP.; Reg House Ask the city about this
eTMF: The electronic version of the trial master file.; Ask the city about this
Excursion: Time outside the allowed temperature.; Central Lab Ask the city about this
Expectedness: Whether a side effect is already listed in the reference safety information.; Safety Watch Ask the city about this

F

Feasibility: Checking if sites can find enough patients before you pick them.; Project Tower Ask the city about this
Follow-up letter: The letter a monitor sends a site after a visit, listing findings and actions.; Terminal C Ask the city about this
FPI: First patient in. The day the first patient joins the study.; Project Tower Ask the city about this
FSP: Functional service provider. A CRO supplying a team that works inside the sponsor's systems.; Careers Corner Ask the city about this

G

GCP: Good clinical practice: the international standard for running trials ethically and well.; Ask the city about this
GLP: Good laboratory practice: the standard for lab studies done before a drug reaches people.; Ask the city about this
GMP: Good manufacturing practice: the standard for making medicines safely and consistently.; Ask the city about this

H

Hybrid: A study with some visits at the site and some at home.; Home Visit Hub Ask the city about this

I

IB: Investigator's brochure. What is known about the drug so far, for investigators.; Reg House Ask the city about this
ICF: Informed consent form: the document a patient reads and signs before joining a study.; Ask the city about this
IEC: Independent ethics committee: the name used outside the US for the committee that approves a study.; Ask the city about this
IIS: Investigator initiated study. A study a doctor designs, that a company may support.; The Exchange Ask the city about this
IMP: Investigational medicinal product: the study drug, including any comparator or placebo.; Ask the city about this
IND: Investigational new drug application: the US filing that lets a company test a new drug in people.; Reg House Ask the city about this
Insight: Something useful a doctor said, written down for the team.; The Exchange Ask the city about this
Interim analysis: A planned look at the results before the study ends.; Ask the city about this
IRB: Institutional review board: the US name for the committee that protects patients in research.; Ask the city about this
IRB or EC: The ethics committee that must approve a study before patients join.; Reg House Ask the city about this
ISF: The investigator site file. The binder, or folder, with every study document the site must keep.; Site 204 Ask the city about this

K

Kit: A packaged set of study supplies, such as drug or lab tubes, with its own number.; Ask the city about this
KOL: Key opinion leader. A doctor other doctors listen to.; The Exchange Ask the city about this

L

Line manager: The person you report to day to day.; Careers Corner Ask the city about this
Lock: Freezing the database so no more changes can be made before analysis.; Ask the city about this
LPO: Last patient out. The day the last patient finishes.; Project Tower Ask the city about this
LTFU: Lost to follow-up: a patient the site can no longer reach.; Ask the city about this

M

Manifest: The list of every sample in a shipment.; Central Lab Ask the city about this
MedDRA: The shared dictionary of words used to code side effects.; Safety Watch Ask the city about this
Monitoring plan: The document that says what a monitor checks, how often and how much.; Ask the city about this

O

Off label: Using a drug in a way that is not approved. MSLs only answer, never suggest.; The Exchange Ask the city about this
Oversight: The investigator staying in charge of what the team does, not just signing at the end.; The Clinic Ask the city about this

P

PI: Principal investigator: the doctor responsible for the study at a site.; The Clinic Ask the city about this
PV: Pharmacovigilance. The work of finding and reporting drug side effects.; Safety Watch Ask the city about this

Q

Query: A question raised on a data point that the site has to answer or correct.; Site 204 Data Works Ask the city about this

R

RACI: A chart that says who does a task, who signs it off and who is told.; Project Tower Ask the city about this
RBM: Risk-based monitoring. Checking more where the risk is, less where it is not.; Terminal C Ask the city about this
Remote SDV: Checking source data without going to the site, through secure access to records.; Ask the city about this
Req: An open job a company has approved to hire for.; Careers Corner Ask the city about this
Requisition: The form that travels with the sample and says what it is.; Central Lab Ask the city about this
Risk-based monitoring: Focusing monitoring effort on the data and sites most likely to go wrong.; Ask the city about this

S

SAE: Serious adverse event: a medical event during a study that is life threatening, needs a hospital stay or worse.; The Clinic Ask the city about this
SAP: Statistical analysis plan: how the results will be analysed, written before unblinding.; Data Works Ask the city about this
Screen fail: A patient who tried to join the study but did not meet the rules to take part.; Site 204 Ask the city about this
Screen failure: A patient who was screened but did not qualify for the study.; Ask the city about this
SDR: Source data review. Reading the records for quality, not ticking each number.; Terminal C Ask the city about this
SDV: Source data verification: checking that what is in the database matches the patient's records.; Terminal C Ask the city about this
Signal: A pattern in safety data that suggests a possible new risk.; Safety Watch Ask the city about this
Site file: The binder or folder at the site that holds the study's essential documents.; Ask the city about this
SOP: Standard operating procedure: a written how-to that everyone must follow.; Ask the city about this
Source: The first place a piece of information was written down, such as the medical chart.; Site 204 Ask the city about this
Sub-I: Sub-investigator: a doctor the PI delegates study tasks to.; Ask the city about this
SUSAR: Suspected unexpected serious adverse reaction: a serious side effect nobody expected, with fast reporting rules.; Safety Watch Ask the city about this

T

TMF: Trial master file: the full set of documents that shows a study was run properly.; Project Tower Ask the city about this

U

Unblinding: Revealing which treatment a patient received.; Ask the city about this
Unsolicited: A question the doctor asked on their own, without being prompted.; The Exchange Ask the city about this
Utilisation: How much of someone's time is billed to studies.; Careers Corner Ask the city about this

V

Visit report: The write-up a monitor files after a visit.; Terminal C Ask the city about this
Visit window: The days around a planned visit when it still counts as on time.; Site 204 Ask the city about this