The ICH guideline for GCP(1) defines the
standard to which Investigators must adhere to when conducting clinical
trials. It is not a requirement of GCP for Investigators to work
according to SOPs. However, many realise that formalising and
documenting procedures provides a means to ensure that the rigorous
standards of GCP are implemented and maintained. This book was written
with the primary aim of providing Investigators with a summary of the
information require in order to facilitate the conduct of clinical
trials in accordance with the ICH guideline.
The presentation of the book is a selection of SOPs
and Checklists, each provided in a clear, concise format that are ready
to use but may be amended to provide a customised portfolio of relevant
documentation.
The SOPs are presented in a logical order. They
follow the flow of a clinical study starting from the organisation and
planning required prior to commencing a clinical study, right through to
archiving trial data. Areas covered therefore include: reviewing and
validated the protocol, obtaining informed consent, managing study drug
supplies, reporting adverse events and clinical results, and being
prepared for monitoring visits, audits and inspections.
Two sample SOPs are included entitled 'Nursing
Procedures' (Application of Nitro-glycerine Ointment) and 'Clinical
procedures' (Standardised Measurement of Blood Pressure). These are
included to encourage and assist medical and nursing staff to prepare
and employ SOPs to cover all practical aspects of the clinical study. In
this way the book emphasises the use of SOPs as a training medium for
clinical staff.
In addition, the book contains an interesting and
brief description of the entire clinical development process including a
summary of the basic principles of GCP. The history and development of
GCP and the international harmonisation process are all explained
clearly and succinctly. A summary of the Investigators responsibilities
and the relationships that exist with Pharmaceutical Companies and CROs
are also included. In the final chapter, the editors have provided a
useful summary of the FDA regulations concerning clinical trials.
The books primary aim is to provide Investigators
with a GCP reference source and to supply a database of standard SOPs
that may be adapted according to specific requirements. For this
function the book excels and should form essential reading for all
medical staff conducting clinical trials. In addition, it may be
recommended to staff involved in the management or monitoring of human
clinical research as an easy-to-use, quick-check summary of the
procedures involved throughout the clinical trial process. In particular
it provides a useful training tool for CRAs, Study Monitors, Medical and
Regulatory Affairs personnel and all involved in preparing and managing
SOPs.
