Terms, Acronyms, and Abbreviations Used in Clinical Trials
Acronyms and Abbreviations
BYOD – Bring Your Own Device – used in decentralized clinical trials, refers to mobile phone or device
CDER – Center for Drug Evaluation and Research
CGMP – Current Good Manufacturing Practice
CRO – Clinical Research Organization
CTM – Clinical Trial Material
DCT – Decentralized Clinical Trials
DPA – Data Privacy Agreement
DSMB – Data and Safety Monitoring Board
eClinical – the application of computerized solutions and processes to support clinical study processes through the automation of previously manual based processes
eCOA – Electronic Clinical Outcome Assessment – Measures how patients feel or function during clinical trials.
EDC – Electronic Data Capture – Computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials.
EMA – European Medicines Agency
ePRO – Electronic Patient Reported Outcome
GCP – Good Clinical Practice
ICH – International Conference on Harmonization
IP – Investigational Product (also referred to as Investigational Drug) – An experimental drug that is being studied to see if the disease or medical condition improves while taking it.
IRT – Interactive Response Technology – IRT is an umbrella term for the technology that clinical trial sites use to manage patient enrollment and randomization, through an Interactive Web Response System (IWRS) or Interactive Voice Response System (IVRS).
IVRS – Interactive Voice Response System
IWRS – Interactive Web Response System
MSA – Master Services Agreement
PRO – Patient Reported Outcome
PS – Project Specification
QAA – Quality Assurance Agreement
RTSM – Randomization and Trial Supply Management – Randomization in clinical trials enables treatment group balance and eliminates selection bias. Clinical trial supply management gets the right investigational drug/supplies delivered to the right subject at the scheduled time.
RtP – Release to Production
SOP – Standard Operating Procedures
UAT – User Acceptance Testing
21 CFR Part 11 – Code of Federal Regulations regarding electronic records and electronic signatures
Terms used in Clinical Trials
Blind – When a clinical trial is considered blind, the subjects involved in the study do not know which study treatment they receive.
Clinical Study – Study conducted by a principal investigator who is often a doctor. Members of the research team regularly monitor the participant’s health to determine the study’s safety and effectiveness. Other words to describe a study are “clinical trial,” “protocol,” “experiment,” and “research.”
Configurable – System changes can be made to meet the specific needs of a clinical trial without requiring days of coding by a vendor’s development and technical support team.
Cohort – In clinical research and statistics, a cohort is defined as a group of individuals who share a characteristic and who are then followed forward in time, with data being collected at one or more suitable intervals. A common use of the term is to describe a birth cohort, in which all the group members are born in a specified time period, but other characteristics could be used, such as marriage date, exposure to an infectious agent, or date of diagnosis or of treatment for a disease.
Double-blind – Patients and the researchers do not know which treatment a subject receives. The intent is to prevent researchers from treating the two groups differently.
Double-blind, randomized, controlled clinical trial – This is a clinical trial in which the researchers evenly divide study participants into a group receiving the experimental intervention and a group receiving standard or no treatment. Neither group knows how it has been assigned. This practice reduces the chance for a “placebo effect,” in which a treatment with no active ingredient produces results expected from a treatment with an active ingredient.
Kits – a general term for the dispensing unit of investigational product or placebo. The kit can contain or reference different methods of provisioning (e.g., bottles, vials, blister cards, preloaded syringes) and may include ancillary supplies needed to assist in dispensing the treatment. Kits can also be:
- Blinded (treatment arm or unique characteristics not identified) or open-label (contents are identified)
- Serialized (has a unique alpha-numeric identification) or non-serialized (generally known by lot number; also known as “bulk”)
- Have a shipping level that is distinct from the kit level. For example: 1 carton contains 6 kits. The carton is shipped to the site with each kit being individually dispensed to a subject.
Modular – The system can be set up so clients only pay for the functionality they need. (The Veeva RTSM solution is built on a configurable, modular foundation that integrates easily with other eClinical systems.)
Placebo – An inactive dose. This is sometimes called a “sugar pill.” In some studies, participants may be assigned to take a placebo rather than the study medication.
Predictive Resupply (also referred to as Predictive Inventory) – Functionality for RTSM platform to generate shipment requests for sites to maintain appropriate inventory levels for any CTM type based on number of active subjects and their progress through a study.
Randomization or random assignment – This is the process in which researchers evenly assign study participants into a group receiving the experimental treatment being studied, and others into a group receiving standard or no treatment. Participants are assigned to a group based on chance, not choice. You have the same chance to be placed in any of the test groups.
Strata – in clinical trials, strata are used to partition subjects and results by a factor other than the treatment, such as gender, age, or other demographic factors.
Stratification – can be used to ensure equal allocation of subgroups of participants to each experimental condition. Stratification can be used to control for confounding variables (variables other than those the researcher is studying).