VICH Topic GL9 (GCP)

1 The European Agency for the Evaluation of MedicinalProductsVeterinary Medicines and Information Technology Unit7 W estferry Circus, Canary W harf, London E14 4HB, UKSwitchboard (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47E-mail: 2000 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA isacknowledgedCVMP/VICH/595/98-FINALL ondon, 4 July2000 VICH Topic GL9 (GCP) Step 7 Consensus GuidelineGUIDELINE ON GOOD CLINICAL PRACTICESTRANSMISSION TO CVMPD ecember 1998 TRANSMISSION TO INTERESTED PARTIESD ecember 1998 COMMENTS REQUESTED BEFOREMay 1999 FINAL APPROVAL BY CVMPJuly 2000 DATE FOR COMING INTO OPERATION BYJuly 2001 FOR IMPLEMENTATION AT STEP 7 (FINAL) 06/00 Page 1 of 27 EMEA 2000 VICH GL9 (GCP)June 2000 For Implementation at Step 7 GGGGOOD CCCCLINICAL PPPPRACTICER ecommended for Implementationat Step 7 of the VICH Processon 15 June 2000by the VICH Steering CommitteeTHISGUIDELINE HAS BEEN DEVELOPED BY THE APPROPRIATEVICH EXPERTWORKINGGROUP AND HASBEEN SUBJECT TO CONSULTATION BY THE PARTIES,IN ACCORDANCE W ITH THEVICH THEPROCESS THE FINAL DRAFT IS RECOMMENDED FOR ADOPTION TO THE REGULATORY BODIES OFTHEEUROPEANUNION,JAPAN IMPLEMENTATION AT STEP 7 (FINAL)

2 06/00 Page 2 of 27 EMEA 2000 Good Clinical PracticeINTRODUCTIONThe objective of this document is to provide guidance on the design and conduct of allclinical studies of veterinary products in the target 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 isintended to ensure that such studies are conducted and documented in accordance withthe principles of Good Clinical Practice (GCP).Good Clinical Practice is intended to be an international ethical and scientific quality standard fordesigning, conducting, monitoring, recording, auditing, analyzing and reporting clinical studiesevaluating veterinary products. Compliance with this standard provides public assurance aboutthe integrity of the clinical study data, and that due regard has been given to animal welfare andprotection of the personnel involved in the study, the environment and the human and animal guidance has been developed under the principles of the International Cooperation onHarmonization of Technical Requirements for Registration of Veterinary Medicinal Products(VICH) and will provide a unified standard for the European Union (EU), Japan and theUnited States of America (USA) to facilitate the mutual acceptance of clinical data by therelevant regulatory authorities.

3 This guidance was developed with consideration of thecurrent practices in the EU, Japan and the USA together with those of Australia and guidance should be followed when developing clinical study data that are intended tobe submitted to regulatory guidance document represents the current best judgment of the relevant regulatoryauthorities on good clinical practices. It does not create or confer rights for or on anyperson and does not operate to bind the relevant regulatory authorities or the public. Analternative approach may be used if such an approach satisfies the applicable regulatoryrequirements. If a sponsor chooses to use alternative procedures or practices, discussionwith the regulatory authority is a guidance document states a requirement imposed by law, the requirement is lawand its force and effect are not changed in any way by virtue of its inclusion in the IMPLEMENTATION AT STEP 7 (FINAL) 06/00 Page 3 of 27 EMEA Adverse Event (AE)Any observation in animals that is unfavorable and unintended and occurs afterthe use of a veterinary product or investigational veterinary product, whether ornot considered to be product Applicable Regulatory Requirement(s)Any law(s) and regulation(s)

4 Of the relevant regulatory authority addressing theconduct of studies using investigational veterinary AuditA systematic and independent examination of study related activities anddocumentation to determine whether the study being evaluated is or wasproperly conducted and whether the data are or were recorded, analyzed andaccurately reported according to the study protocol, study related standardoperating procedures (SOPs), GoodClinical Practice (GCP) and theapplicableregulatory Authenticated CopyA copy, which is a complete reflection of an original document, that bears orcontains a statement, signed and dated by the individual(s) making the copy,certifying that such copy is complete and Blinding (Masking)A procedure to reduce potential study bias in which designated study personnelare kept uninformed of the treatment assignment(s).

5 Case Report Forms/Data Capture Forms/Record SheetsPrinted, optical, electronic, or magnetic documents specifically designed torecord study protocol-required and other observations of study animals orlaboratory Clinical StudyA single scientific experiment conducted in a target species to test at least onehypothesis relevant to the proposed effectiveness claim(s) or to in-use safety inthe target animal for a veterinary product under investigation. For the purposeof this guidance, the term clinical study and study are Compliance (in relation to studies)Adherence to the study protocol, relevant SOPs, GoodClinical Practice, and theapplicable regulatory Control ProductAny approved product used according to label directions, or any placebo, usedas a reference in a clinical study for comparison with the investigationalveterinary product under IMPLEMENTATION AT STEP 7 (FINAL) 06/00 Page 4 of 27 EMEA Contract Research Organization (CRO)An individual or organization contracted by the sponsor or investigator toperform one or more of the obligations of the sponsor or Disposal of Investigational Veterinary ProductsThe fate of investigational veterinary and control products during or followingcompletion of the study.

6 For example, after complying with any restrictions tominimize public health concerns, the products may be returned to the sponsor,incinerated or disposed of by other approved of Study AnimalsThe fate of the study animals or their edible products during or followingcompletion of the study. For example, after complying with any restrictions tominimize public health concerns, animals may be slaughtered, returned to theherd, sold or returned to their Final Study Report (FSR)A comprehensive description of a study of an investigational veterinary productthat is written after the collection of all raw data is complete or the study isdiscontinued and that completely describes the objectives and experimentalmaterials and methods (including statistical analyses), presents the study resultsand contains a critical evaluation of the study Good Clinical Practice (GCP)A standard for the design, conduct, monitoring, recording, auditing, analysis,and reporting of clinical studies.

7 Adherence to the standard provides assurancethat the data and reported results are complete , correct and accurate, that thewelfare of the study animals and the safety of the study personnel involved inthe study are ensured, and that the environment and the human and animalfood chains are Informed ConsentA documented process by which an owner, or owner s agent, voluntarilyconfirms the owner s willingness to allow their animal(s) to participate in aparticular study, after having been informed of all aspects of the study that arerelevant to the decision to InspectionThe act by a relevant regulatory authority of conducting, in accordance with itslegal authority, an official review of study documentation, facilities,equipment,finished and unfinished materials (and associated documentation), labeling, andany other resources related to the registration of an investigational veterinaryproduct and that may be located at any site related to the Investigational Veterinary ProductAny biological or pharmaceutical form of, or any animal feed containing one ormore active substances being evaluated in a clinical study, to investigate anyprotective, therapeutic, diagnostic, or physiological effect when administered orapplied to an IMPLEMENTATION AT STEP 7 (FINAL)

8 06/00 Page 5 of 27 EMEA InvestigatorAn individual responsible for all aspects of the conduct of a study at a study a study is conducted by a group of individuals at a study site, the investigatoris the leader of the MonitorAn individual responsible for overseeing a clinical study and ensuring that it isconducted, recorded, and reported in accordance with the study protocol,Standard Operating Procedures (SOPs), GoodClinical Practice (GCP) and theapplicable regulatory Multicenter StudyA study conducted according to a single study protocol at more than one Quality Assurance (QA)A planned and systematic process established to ensure that a study isperformed and the data are collected, documented (recorded) and reported incompliance with this guidance and the applicable regulatory Quality Control (QC)The operational techniques and activities undertaken within the qualityassurance system to verify that the requirements for quality of the study-relatedactivities have been RandomizationThe process of assigning study animals (or groups of study animals) totreatment or control groups using an element of chance to determine theassignments in order to reduce Raw DataAny original worksheets, calibration data, records, memoranda and notes offirsthand observations and activities of a study that are necessary for thereconstruction and evaluation of the study.

9 Raw data may include, but are notlimited to, photographic materials, magnetic, electronic or optical media,information recorded from automated instruments, and hand recordeddatasheets. Facsimile transmissions and transcribed data are not consideredraw Regulatory AuthoritiesBodies having the statutory power to regulate. In this guidance, the expression regulatory authorities includes the authorities that review submitted clinical dataand conduct SponsorAn individual, company, institution or organization which takes responsibility forthe initiation, management, and financing of a clinical study for the veterinaryproduct under IMPLEMENTATION AT STEP 7 (FINAL) 06/00 Page 6 of 27 EMEA Standard Operating Procedure (SOP)A detailed, written instruction to facilitate consistency in the performance of aspecific Study AnimalAny animal that participates in a clinical study, either as a recipient of theinvestigational veterinary product or as a Study ProtocolA document signed and dated by the investigator and the sponsor that fullydescribes the objective(s), design, methodology, statistical considerations andorganization of a study.

10 The study protocol may also give the background andrationale for the study but these could be provided in other study protocol-referenced this guidance the term study protocolincludes all study protocol Study Protocol AmendmentA written change or modification of the study protocol effected prior to theimplementation of the protocol or execution of the changed or modified protocol amendments should be signed and dated by the investigator andsponsor and incorporated into the study Study Protocol DeviationA departure from the procedures stated in the study protocol. Study protocoldeviations should be recorded as a statement signed and dated by theinvestigator describing the deviation and the reason for its occurrence (ifidentifiable). Target AnimalThe specific animal by species, class and breed identified as the animal forwhich the investigational veterinary product is intended for Veterinary ProductAny product with approved claims to having a protective, therapeutic ordiagnostic effect or to affect physiological functions when administered to orapplied to an animal.