Rebecca Garland & Judi Eaton
Keywords
linical trial administrator (CTA), Manual, Reference document, Special Interest Group (SIG)
The Clinical Trial Administrator Special Interest Group (CTA SIG) is proud to announce the launch of a CTA Manual, written for CTAs by CTAs, to serve as a centralised reference document for CTAs throughout the industry. This document contains essential background information, covering topics such as the structure of a typical clinical department, industry-related acronyms, some of the key roles and responsibilities of a CTA and a snapshot of relevant areas of clinical research and its processes.
The journey started when two members of the CTA SIG, Marilyn Errington and Tina Rickard, suggested the creation of a CTA manual to sit alongside ICR’s booklet ‘To be a CTA’. The aim of the manual was to consolidate useful information pertinent to CTAs in their day-to-day role. The intention was that the finished product would be readily accessible to the CTA community or other similar roles within the industry. The CTA SIG discussed this in length and decided that the industry would benefit from such a document; so, the CTA Manual was born.
Its public debut was made at the ICR CTA Forum in November 2008. The first draft was presented by Marilyn and Tina to the forum’s attendees for review and discussion. The document provoked interest and debate, and throughout its development it has been subject to invaluable input from CTAs from across the sector (ie, CRO, pharma, NHS Trusts etc.). CTAs volunteered or were invited to write sections, which has also undergone many extensive review processes by CRAs, project managers and other CTAs, to make it the credible document it is today.
It is impossible to cover every potential eventuality, as the CTA role can be extremely varied and diverse from one organisation to another. The manual is certainly not intended to give definitive instructions on how to perform the CTA role, nor to replace organisations’ SOPs or Working Instructions; rather it is intended as a guide and reference tool to assist both experienced CTAs and those who are new to the industry.
The manual will be updated on an ongoing basis, as the role, the industry and legislation evolve.
The CTA SIG hopes that readers will find the manual relevant and interesting to their CTA careers and would like to thank all those who provided their input.
The Manual can be found on the CTA SIG pages on the ICR website.
If you would like to provide feedback on the manual, or are interested in becoming a member of the CTA SIG, please contact us at
sig@icr-global.org.
Rebecca Garland is a Clinical Trials Administrator with Teva Pharmaceuticals Ltd and a member of the ICR Clinical Trial Administrator Special Interest Group. Judi Eaton is a Senior Clinical Trials Administrator with Chiltern and Chair of the ICR Clinical Trial Administrator Special Interest Group.
