We provide publications from the British Association of Research Quality Assurance

The following useful booklets are available. They are A5 in size, bound with a  paper cover and range from 9 to 40 pages in length.

• Pharmacovigilance Auditing
• Pharmacovigilance Inspection Guidance
• The Role of the Monitor in Veterinary Clinical Studies
• A Practical Guide to GLP Quality Assurance
• Good Clinical Laboratory Practice
• Guidelines for Quality in Non-Regulated Scientific Research
• Electronic Standard Operating Procedures
• Investigator Site Audits; Guide for Monitors
• Routine Investigator Site Audits; Guide for Investigators

You may order these titles directly from Canary or online using our Internet bookshop

For more information about BARQA membership and professional development courses click here: BARQA website

Pharmacovigilance Auditing

ISBN 1-904610-05-6

Authors: Helen Powell & members of the BARQA Good Pharmacovigilance Working Party

This publication provides guidance to auditors to enable them to conduct a pharmacovigilance system audit. The booklet is fairly comprehensive embracing activities managed by central functions and those that may be conducted by an affiliate company. It is envisaged that an auditor would select those groups or areas that are applicable to the system they wish to audit.

 £10.00

Pharmacovigilance Inspection Guidance

ISBN 1-904610-04-8

Authors: Allison Jack & members of the BARQA Good Pharmacovigilance Working Party

This publication is a useful and easy to read guide full of practical tips on how to manage pharmacovigilance inspections.

£10.00

The Role of the Monitor in Veterinary Clinical Studies

ISBN 1-904610-06-4

Authors: BARQA Animal Health Committee & SQA Animal Health Speciality Section

Regulatory requirements for veterinary clinical studies have developed over the last 24 years. This publication covers the current best practice for the clinical study monitor. The publication is based on and develops the guidance found in VICH GL9.

£10.00

A Practical Guide to GLP Quality Assurance

ISBN 1-904610-07-2

Authors: The BARQA GLP Committee

UK GLP Regulations 1 and the OECD Principles 2 on which they are based, provide information on the requirements for Quality Assurance of studies in compliance with Good Laboratory Practice. These standards are further interpreted by the OECD document on Quality Assurance and GLP 3. Nevertheless, during moderation of the BARQA GLP discussion forum in 2003-5, it became apparent to the BARQA GLP Committee that there remain some areas requiring guidance as to best practice. In particular, it was the view of the committee that some relatively fundamental issues were ill-defined in GLP publications, perhaps because they are considered to be self-evident.

This publication aims to provide helpful guidance with such issues. Whilst this document is based on UK regulation and experience, it also addresses areas where QA input is useful, as well as those which are statutory requirements. Since multi-site studies raise additional, specific issues for QA personnel, a separate section addressing this subject is appended.

£10.00

Good Clinical Laboratory Practice

ISBN 1-904610-00-5

This excellent guide is the product of a BARQA working party
(Tim Stiles, Vanessa Grant, Nick Mawbey).

It provides guidance on the systems and procedures that should be in place within an organisation that conducts analyses of samples from clinical trials.

£20

Guidelines for Quality in Non-Regulated Scientific Research

ISBN 1-904610-08-0

Authors: BARQA Working Party on Quality in Non-Regulated Research

The aim of this guideline publication is to facilitate the straightforward development of a Quality System in any research institution, irrespective of discipline, which has no previous experience of such process. A structure of ten subject matter sections has been adopted so as to provide a simple, pragmatic "get started" model for Quality systems in Non-Regulated Scientific Research.

£10.00

Electronic Standard Operating Procedures

ISBN 1-904610-03-X

Authors Barbara Kay-Farrow - Quintiles, Chris Montgomery - Celltech, David Kill - PAREXEL, Janice Birnie - QA File-Away, Jean Samuel - Pfizer, Richard Winning - AstraZeneca, Tony Watts - Q-Excel

This publication provides information on a number of key aspects of electronic SOPs.  It was finalised by a BARQA working party in 2003 and updates a previous version, developed in 1998.

The publication provides information on:

• The different categories of e-SOP system available
• The regulatory implications of e-SOP systems
• The benefits of introducing such a system
• IT considerations

It also contains information that would help in developing or purchasing an e-SOP system.

£10

Investigator Site Audits

BARQA Guide for Monitors

ISBN 1-904610-02-1

This useful 10-page booklet provides advice for monitors and auditors in response to a number of questions relating to investigator site audits including:

• How are investigator sites selected for audit?
• When are sites audited?
• Why are audits performed?
• What is the audit procedure?

Information about reporting and follow-up, audit certificates and letters to investigators is also provided.

£10

Routine Investigator Site Audits

BARQA Guide for Investigators

ISBN 1-904610-01-3

This useful 6-page booklet provides information for investigators in response to a number of questions relating to investigator site audits including:

• How are investigator sites selected for audit?
• What is Good Clinical Practice?
• What will the audit involve?

Information is also provided about pre-audit preparation and regulatory inspections. A flow sheet of the investigator site audit is included.

£10