Use of Booklet Labels on Investigational Medicinal Products (IMPs)
1 Introduction
It is current practice to use booklet labels for labelling of Investigational Medicinal Products (IMPs) to be used in multinational clinical trials.
Many companies use multinational clinical trials to locate potential subjects for testing new medications, and most countries require that labels on IMPs be in their local language.
Studies are performed in multinational and multilingual trials. Since there is no universal guidance covering the aspect of how to label, a broad range of approaches has been developed within the industry. An economic and flexible solution is booklet labels.
The ISPE IP COP Booklet Label Task Team was formed in order to respond to concerns in regard to content, readability, and correct usage of booklet labels. Their intention is to develop an ISPE Good Practice Guide for standardization of booklet label content and form in addition to driving improvement of user friendliness.
The objective of this concept paper is to reflect on a study site survey performed, to draw conclusions from an assessment on comparison of Booklet Labels versus Single Panel Labels performed, to discuss benefits of a Good Practice Guide, and to define the need for training on the proper use of booklet labels. The Good Practice Guide for Booklet Labels will be based on the conclusions and assumptions of the concept paper.
This report does not imply that a competent authority in any country agrees with the conclusions and assumptions of the concept paper.
2 Acronyms and Glossary
For the purposes of this technical report, the following terms are used and accompanied by their synonyms where applicable.
Base Label
The part of the booklet label which is applied to the primary or secondary packaging of the IMP.
Batch Number
Lot no., code no., requisition number, packaging run number, or equivalent.
Binding Area
Located left or right from the cover page on the booklet label.
Booklet Label
A combination of a label and a booklet/leaflet containing multiple pages with information.
Caution Statement
Covering Annex 13: “For clinical trial use only,” “keep out of reach of children,” etc.
Clinical Trial
Clinical study.
Clinical Trial Application
Regulatory submission to allow execution of a clinical trial.
Closing Area
Located right or left from the cover page of the booklet label, area where label is opened and closed.
Competent Authority
Health authorities, Ministry of Health; a body with authority to act on behalf of the government of the respective country/state.
Cover Page
Front page of the booklet label.
Direction for Use
Written information to the site and/or subject on how to use the investigational products.
Dispensing
Provision of IMP for subject use for home treatment or for hospital administration to subject. Refers to IMP which has been packaged in accordance with regulations and is ready for administration to the subject.
Expiry Date
Date by which the product expires and cannot be extended.
Inner Pages
Containing the table of content and the country specific translated pages, in the official local language(s) of the respective countries.
Interactive Response Technology (IRT)
Centralized electronic randomization system used in clinical trial for but not limited to randomization and medication management. Two methods included: voice and/or web.
Interactive Voice Response (IVR) System
Computerized technology which combines the use of databases and telephones to input, retrieve, and manage information.
Interactive Web Response (IWR) Technology
Computerized technology which combines the use of databases and the internet to input, retrieve, and manage information.
Investigational Medicinal Products (IMP)
Investigational products, trial products, trial medication, clinical supplies, study drug, etc.
Kit Number
Unique identifier for a packaged unit used within a clinical trial; dispensing unit, Box #, Pack ID, IRT Number, Med ID.
Manual Re-Labelling Process
The process of creation, approval, and issuance of labels (IMP or auxiliary labels) for the purpose of updating retest dates currently on IMP containers at warehouses, depots, or clinical study sites.
Name of Investigator
Name of the principal investigator at a site participating in a clinical trial responsible for the clinical trial and emergency contact for the subject.
Pharma Industry
Life science industry, biopharmaceuticals, pharmaceuticals industry.
Primary Packaging
Immediate container with IMP.
Removable Panel
The part of the label that can be either removed or detached from the booklet label itself. A tear-off/peel-off label acts as a self-adhesive label used for documentation at the site.
Retest Date
Use period can be extended.
Secondary Packaging
Outer box/carton containing primary containers with IMP.
Single Panel Label
A label with just one layer; affixed directly onto the container containing one or more languages limited by size.
Site
Clinical site/centre/clinic/unit/hospital participating in a clinical trial.
Sponsor
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
Subject
An individual who participates in a clinical trial as either a recipient of the investigational medicinal product or a control; patient, volunteer.
Subject Number
Trial subject identification number.
Subject Safety
Patient care, patient safety.
Top Layer
The part of the booklet label visible when the booklet is closed.
Treatment Number
Treatment identification number assigned to the subject according to the randomization schedule and that relates to the investigational medicinal product(s) contained in the kit.
Trial Reference Code
Identification code of the trial, site, investigator, and sponsor; trial ID; protocol number, etc.
Use by Date
Indicates the period of use in month/year format and in a manner that avoids any ambiguity; retest date/expiry date.
Visit Number
Identification number of the protocol visit the investigational products are intended for.
Read more by downloading Use of Booklet Labels on Investigational Medicinal Products (IMPs) (Published: February 2012).