Glossary

Ethics committee meetings

Ethics committee meetings are conducted to review and evaluate the ethical aspects of proposed trials. These meetings are conducted independently of the trial sponsor or investigators.

Investigational product (IP)

Also referred to as an investigational medical product (IMP), this is the substance or treatment being studied for its potential therapeutic effects in a clinical trial.

Investigator meetings

An investigator meeting is where the trial sponsor or Contract Research Organisation (CRO) gathers principal investigators and key clinical trial staff to provide training and information about a specific trial, usually before patient screening begins.

Investigator visit

These are visits conducted to the research site to ensure the study is set up, conducted, and closed out in compliance with the protocol, regulatory requirements, and good clinical practice (GCP).

Lab kit

A lab kit, also referred to as a test kit, is a pre-assembled package containing all necessary components for collecting, processing, and transporting biological samples or conducting specific procedures during a clinical trial.

Monitor visits

A monitor visit is when the trial sponsor or a third party visits the trial site to perform quality control measures such as verification that the study protocol is being adhered to, or checking that informed consent is appropriately documented. These visits are usually performed throughout a trial’s duration and conducted in the form of a meeting.

Over supply

Also referred to as overage, is the term for a deliberate buffer of product to cover variability in the demand for that product during a trial, which usually results in unused product.

Per participant

Total amount needed for each participant in the trial for the whole trial period, not including over supply.

Per trial

Total amount of something needed for the whole trial period, including over supply.

Site visit

A trial participant will attend a site for data collection, monitoring or examination as part of the clinical trial.

Total spend

This is a monetary value, representing the spend across the whole trial from start to finish in the chosen currency. The conversion of monetary data to trial emissions is less accurate and should only be used where quantity data is not available.

Trial management staff

These are staff who oversee the entire trial across multiple sites, and who are responsible for its overall planning, execution and coordination, such as trial managers, data managers and trial statisticians.

Trial participants

This terminology may be setting-specific, and is used here to broadly include ‘cohort’, ‘patients’, ‘subjects’, ‘volunteers’ etc.

Trial site staff

These are staff directly involved in conducting the trial at a specific site, such as principal investigators, clinical research nurses and clinical trial pharmacists. This staff group interact directly with trial participants and are responsible for implementing the trial protocol at the site.

Acronyms and Abbreviations

Abbreviation	Full name
ERM	Environmental Resources Management
GHG	Greenhouse gas(es)
iLCCT	Industry Low Carbon Clinical Trials group
IMP	Investigational medicinal product
LCA	Life cycle assessment
PCF	Product carbon footprint
SHC	Sustainable Healthcare Coalition
SMI	Sustainable Markets Initiative
SOP	Standard operating procedure