GCP guidelines about Clinical trial in animals!!!

INTRODUCTION
The objective of this document is to provide guidance on the design and conduct of all
clinical studies of veterinary products in the target species.
It is directed at all individuals and organizations involved in the design, conduct, monitoring,
recording, auditing, analysis and reporting of clinical studies in target species and is
intended to ensure that such studies are conducted and documented in accordance with
the principles of Good Clinical Practice (GCP).
Good Clinical Practice is intended to be an international ethical and scientific quality standard for
designing, conducting, monitoring, recording, auditing, analyzing and reporting clinical studies
evaluating veterinary products. Compliance with this standard provides public assurance about
the integrity of the clinical study data, and that due regard has been given to animal welfare and
protection of the personnel involved in the study, the environment and the human and animal food
chains.
This guidance has been developed under the principles of the International Cooperation on
Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH) and will provide a unified standard for the European Union (EU), Japan and the
United States of America (USA) to facilitate the mutual acceptance of clinical data by the
relevant regulatory authorities. This guidance was developed with consideration of the
current practices in the EU, Japan and the USA together with those of Australia.

THE PRINCIPLES OF VICH GCP
2.1. The purpose of the VICH GCP is to establish guidance for the conduct of clinical
studies that ensures the accuracy, integrity and correctness of data. Due regard
should be given to the welfare of the study animals, the effects on the
environment and the study personnel and to residues in the edible products
derived from food-producing study animals.
2.2. Pre-established systematic written procedures for the organization, conduct,
data collection, documentation and verification of clinical studies are necessary
to assure the validity of data and to ensure the ethical, scientific and technical.
quality of studies. Data collected from studies designed, conducted, monitored,
recorded, audited, analyzed and reported in accordance with this guidance can
be expected to facilitate the review process since the regulatory authorities can
have confidence in the integrity of studies which follow such pre-established
written procedures.
2.3. By following such pre-established written procedures, it is likely that sponsors
can avoid unnecessary repetition of definitive studies. Any requirement for local
effectiveness studies to confirm the findings of the definitive studies is not
affected by this guidance document. In addition, other guidance may exist
which define study design and effectiveness criteria for specific veterinary
product categories. These studies also should be conducted according to GCP
principles.
2.4. Each individual involved in conducting a clinical study should be qualified by
education, training, and expertise to perform their respective task(s). These
individuals should demonstrate, in a manner that is evident from the study
documentation, the highest possible degree of professionalism in the recording
and reporting of study observations.
2.5. The relevant regulatory authority should provide procedures that independently
assure that the study animals and the human and animal food chains are
protected. The relevant regulatory authority should also assure that informed
consent has been obtained from the owner of the study animals.
2.6. Studies covered by Good Laboratory Practice (GLP), basic exploratory studies
or other clinical studies not intended to be used for regulatory support are not
included in the scope of this guidance. However, data derived from safety and
pre-clinical studies may be required to be submitted to the relevant regulatory
authority in order that subsequent clinical studies may be properly authorized
prior to commencement.
2.7. Wherever possible, investigational veterinary products should be prepared,
handled and stored in accordance with the concepts of good manufacturing
practice (GMP) of the relevant regulatory authorities. Details of preparation,
handling and storage of investigational veterinary products should be
documented and the products should be used in accordance with the study
protocol.
2.8. The assurance of quality of every aspect of the study is a fundamental
component of sound scientific practices. The principles of GCP support the use
of quality assurance (QA) procedures for clinical studies. It is perceived that the
sponsor would be the party responsible for the QA functions for these studies.
All participants in clinical studies are encouraged to adopt and adhere to
generally recognized sound QA practices.�