Alphabet Soup (Abbreviations)
This three-letter abbreviation represents the independent administrative body that reviews and approves clinical trials to protect human subjects
What is IRB?
This document must be signed by the participant before any protocol-specific procedures can begin
What is the Informed Consent Form?
This is the medical provider who takes full legal and clinical responsibility for the conduct of the trial at the site
What is a Principal Investigator/PI?
This continuous heart-monitoring is standard in Phase 1 trials to watch for cardiac changes
What is telemetry?
A participant misses their follow up visit entirely and ghosts you calls for a week
What is a missed visit?
This abbreviation refers to the first dose given to participants in a human trial
What is FIH?
This is the first place where clinical data (ex. questionnaires) is recorded before entering it into the Electronic Data Capture (EDC) system
This team member manages day-to-day study activities, schedules visits, and ensures protocol procedures are followed
What is a Clinical Research Coordinator?
This action may be required by the medical providers if a participant experiences severe toxicity, as outlined in the protocol
What is dose modification (or dose interruption/discontinuation)?
This participant forgets their dosing diary...again...for the third visit in a row
What is noncompliance?
This three-letter abbreviation refers to an unexpected medical occurrence that results in death, is life threatening, or requires inpatient hospitalization
What is a SAE?
If a PK blood draw is missed or done outside the allowed protocol window, this specific issue must be documented as a
What is a protocol deviation?
This specialized professional on site is legally authorized to handle, compound, and dispense the investigational product
What is the study pharmacist?
What is within 24 hours?
This document created by coordinators indicates the exact minute by minute timeline for when procedures should be conducted. It is NOT optional but sometimes is treated as a suggestion by participants
What is the Schedule of Assessments?
This three-letter abbreviation refers to the official document a pharmaceutical company must file with the FDA before they can test a new drug in human
What is an IND? (Investigational New Drug application)
This approach gives the study drug to one or few participants before dosing the rest of the cohort
What is sentinel dosing?
Performs clinical procedures like vitals, ECGs, blood draws, and assessments per protocol
Who is the Research Nurse and/or Clinic staff?
Role responsible for monitoring study safety and data
What is a Data Safety Monitoring Board (DSMB)?
At the time the discharge instructions are provided by the coordinator, the participant states, "I don't need a copy, I have a really good memory"
What is "you are still getting a copy of the signed discharge instructions?"
This three-letter abbreviation stands for the international ethical and quality standard that designs, conducts, and reports clinical trials involving human subjects
What is GCP? (Good Clinical Practice)
This principle requires data to be attributable, legible, contemporaneous, original, and accurate
What is ALCOA?
This role is responsible for regulatory binders, IRB submissions, and maintaining essential documents per protocol
Who is the Regulatory Coordinator?
This is the term for the period after dosing where a participant must stay at the clinic for continuous safety observation
What is the inpatient confinement period?
A participant provides inconsistent answers at different visits about medication use and symptoms, with no clear documentation errors from the site
What is unreliable participant reporting (data integrity concern)?