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.
ISPE Good Practice Guide: Booklet Labels | Good Practice Guides
Because booklet labels contain vital information for testing sites and subjects, this Guide promotes more consistent use of booklet labels to reduce confusion and non-compliance. It offers guidance on how to design and structure a booklet label …
Good Practice Guide: Booklet Labels - ISPE
It offers guidance on how to design and structure a booklet label and standardize their use and application. Additionally, it addresses the regulatory requirements of many countries and the practicability needs of the users with the goal of making booklet labels easy to follow and use.
7. INVESTIGATOR’S BROCHURE: ICH E6 (R2) Good clinical practice
The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product (s) that are relevant to the study of the product (s) in human subjects.
The Investigator’s Brochure (IB) is a compilation of all relevant nonclinical and clinical data for a drug undergoing clinical investigation. It is an important source of
Booklet Labels for IMPs - Faubel & Co. Nachf. GmbH
What characterizes a label for Investigational Medical Products (IMPs)? In the case of investigational medicinal products, the labeling must ensure the protection of individuals and traceability, enable the identification of the medicinal product and the trial, and ensure proper use of the medicinal product.
These guidelines will facilitate the adoption of best practices by new and established clinical research pharmacies (e.g., investigational drug service [IDS]) in collaboration with the pharmaceutical industry for the optimal management of in-vestigational drug products.
This guideline applies to interventional clinical trials of investigational products1 that are intended to be submitted to regulatory authorities. The Principles of GCP in this guideline may
The purpose of regulatory labelling requirements for investigational medicinal products (IMPs) in clinical trials (CTs) is to provide added value regarding • Protection of the subjects • Identification of the IMP • Traceability of the IMP • Proper use of the IMP • Identification of the trial • Proper documentation of the trial
Use of Booklet Labels on Investigational Medicinal Products …
Feb 1, 2012 · Based on the great variability in booklet label design and use, a pharma industry benchmark on product complaints related to labels and the ISPE IRT Investigational Site Survey assessment has been performed to assess the potential increased risk …