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International Clinical Trials

Shredding Paper

The informed consent process represents the keystone in a
clinical trial, the space where science meets the patient. As
healthcare began to globalise in the 1990s and 2000s, process
and presentation flexibility became crucial. With technology
spreading around the globe, the defects and difficulties in the
use of text-only documents, reported internationally for 30
years, became even more apparent. Patients worldwide decreed
that text-only paper consent forms were confusing, hard to
and sometimes in different languages. Patients frequently
breezed through paper forms without truly understanding
the material and were surprised by aspects of the trial once it
started. This led to frustration and subjects often dropped out
of the consent process or the trial itself.

With the globalisation of clinical research, creating a flexible
system that works across international boundaries, yet respects
the differences of countries and regions, is imperative.

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Eric Delente, President at DrugDev Patient Solutions, has more than 20 years of experience leading technical and creative teams in the design and implementation of numerous award-winning online science, healthcare and clinical research web applications. Most recently, he led SecureConsent, the industry’s definitive eConsent solution.
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Eric Delente
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Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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7-8 February 2018, Hall 7.1, Paris Expo, Porte de Versailles, Paris.

As Europe's dedicated Pharmaceutical Packaging and Drug Delivery event, Pharmapack is the industry's go-to place to kick-off the year.
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