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85 
  
Guidance for Industry 
 
G C P  
OOD  LINICAL  RACTICE
 
VICH GL9 
 
FINAL GUIDANCE 
 
(This document was revised on June 8, 2011 to update the contact information, add the 
Table of Contents, update hyperlinks, and minor formatting changes) 
 
This final guidance is intended to provide guidance on the design and conduct of all 
clinical studies of veterinary medicinal products in the target species submitted for 
approval to the European Union, Japan, and the United States. 
 
Comments and suggestions regarding this guidance should be sent to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, Rockville, MD  20852.  Comments may also be submitted electronically on 
the Internet at http://www.regulations.gov.  All written comments should be identified 
with Docket No 99D-2406. 
 
For questions regarding this guidance document, contact Herman M. Schoenemann 
(HFV-100),  Center  for  Veterinary  Medicine,  Food  and  Drug  Administration,  7500 
Standish  Pl.,  Rockville,  MD  20855,  240-276-8302,  e-mail: 
herman.schoenemann@fda.hhs.gov. 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
May 9, 2001 
 
   
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VICH GL9 (GCP) 
June 2000 
For Implementation at Step 7 
 
 
 
 
 
 
G C P  
OOD  LINICAL  RACTICE
 
 
 
 
 
 
 
Recommended for Implementation  
at Step 7 of the VICH Process 
on 15 June 2000 
by the VICH Steering Committee 
 
 
 
 
 
 
 
 
 
THIS GUIDANCE HAS BEEN DEVELOPED BY THE APPROPRIATE VICH EXPERT WORKING GROUP 
AND HAS BEEN SUBJECT TO CONSULTATION BY THE PARTIES, IN ACCORDANCE WITH THE VICH 
PROCESS.  AT STEP 7 OF THE PROCESS THE FINAL DRAFT IS RECOMMENDED FOR ADOPTION TO 
THE REGULATORY BODIES OF THE EUROPEAN UNION, JAPAN AND USA. 
 
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Final Guidance ......................................................... 1 
INTRODUCTION....................................................... 5 
1.  GLOSSARY..................................................... 6 
1.1.  Adverse Event (AE)............................................. 6 
1.2.  Applicable Regulatory Requirement(s) .............................. 6 
1.3.  Audit ........................................................ 6 
1.4.  Authenticated Copy............................................. 6 
1.5.  Blinding (Masking) ............................................. 6 
1.6.  Case Report Forms/Data Capture Forms/Record Sheets ................ 6 
1.7.  Clinical Study ................................................. 6 
1.8.  Compliance (in relation to studies)................................. 6 
1.9.  Control Product................................................ 6 
1.10.  Contract Research Organization (CRO)............................ 7 
1.11.  Disposal of Investigational Veterinary Products..................... 7 
1.12.  Disposal of Study Animals ..................................... 7 
1.13.  Final Study Report (FSR)....................................... 7 
1.14.  Good Clinical Practice (GCP) ................................... 7 
1.15.  Informed Consent ............................................ 7 
1.16.  Inspection.................................................. 7 
1.17.  Investigational Veterinary Product ............................... 7 
1.18.  Investigator................................................. 8 
1.19.  Monitor .................................................... 8 
1.20.  Multicenter Study ............................................ 8 
1.21.  Quality Assurance (QA)........................................ 8 
1.22.  Quality Control (QC) .......................................... 8 
1.23.  Randomization .............................................. 8 
1.24.  Raw Data................................................... 8 
1.25.  Regulatory Authorities ........................................ 8 
1.26.  Sponsor.................................................... 9 
1.27.  Standard Operating Procedure (SOP)............................. 9 
1.28.  Study Animal................................................ 9 
1.29.  Study Protocol .............................................. 9 
1.30.  Study Protocol Amendment .................................... 9 
1.31.  Study Protocol Deviation....................................... 9 
1.32.  Target Animal ............................................... 9 
1.33.  Veterinary Product ........................................... 9 
2.  THE PRINCIPLES OF VICH GCP ..................................... 9 
3.  THE INVESTIGATOR ............................................. 11 
3.1.  General...................................................... 11 
3.2.  Responsibilities.   ............................................. 11 
4.  THE SPONSOR ................................................. 14 
4.1.  General.  .................................................... 14 
4.2.  Responsibilities.   ............................................. 14 
4.3.  Delegations to a CRO........................................... 16 
5.  THE MONITOR.................................................. 17 
5.1.  General.  .................................................... 17 
5.2.  Responsibilities.   ............................................. 17 
6.  THE STUDY PROTOCOL.......................................... 19 
6.1.  General...................................................... 19 
6.2.  Study Protocol Review.  . ....................................... 19 
6.3.  Study Protocol Check List.  :..................................... 19 
7.  THE FINAL STUDY REPORT ....................................... 24 
7.1.  General...................................................... 24 
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7.2.  Authorship................................................... 24 
7.3.  Content of Final Study Report.   .................................. 25 
7.4.  Report Amendments.  .......................................... 28 
8.  STUDY DOCUMENTATION ........................................ 28 
8.1.  General...................................................... 28 
8.2.  Categories of study documentation.  .............................. 29 
8.3.  Recording and handling study documentation. ...................... 30 
8.4.  Retention of study documentation................................. 31 
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GOOD CLINICAL PRACTICE 
 
This guidance represents FDAs current thinking on this matter and does not 
create or confer any rights for or on any person, and does not operate to bind 
FDA or the public. An alternate method may be used as long as it satisfies the 
requirements of the applicable statutes and regulations.  
 
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 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 and New Zealand. 
 
This guidance should be followed when developing clinical study data that are intended 
to be submitted to regulatory authorities. 
 
When a guidance document states a requirement imposed by law, the requirement is 
law and its force and effect are not changed in any way by virtue of its inclusion in the 
guidance document. 
 
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1.  GLOSSARY 
 
1.1.  Adverse Event (AE) 
Any observation in animals that is unfavorable and unintended and occurs 
after the use of a veterinary product or investigational veterinary product, 
whether or not considered to be product related. 
 
1.2.  Applicable Regulatory Requirement(s) 
Any law(s) and regulation(s) of the relevant regulatory authority addressing 
the conduct of studies using investigational veterinary products. 
 
1.3.  Audit 
A systematic and independent examination of study related activities and 
documentation to determine whether the study being evaluated is or was 
properly conducted and whether the data are or were recorded, analyzed 
and  accurately  reported  according  to  the  study  protocol,  study  related 
standard operating procedures (SOPs), Good Clinical Practice (GCP) and 
the applicable regulatory requirements. 
 
1.4.  Authenticated Copy 
A copy, which is a complete reflection of an original document, that bears 
or contains a statement, signed and dated by the individual(s) making the 
copy, certifying that such copy is complete and accurate. 
 
1.5.  Blinding (Masking) 
A  procedure  to  reduce  potential  study  bias  in  which  designated  study 
personnel are kept uninformed of the treatment assignment(s). 
 
1.6.  Case Report Forms/Data Capture Forms/Record Sheets 
Printed, optical, electronic, or magnetic documents specifically designed to 
record study protocol-required and other observations of study animals or 
laboratory results. 
 
1.7.  Clinical Study  
A single scientific experiment conducted in a target species to test at least 
one hypothesis relevant to the proposed effectiveness claim(s) or to in-use 
safety in the target animal for a veterinary product under investigation.  For 
the  purpose  of  this  guidance,  the  term  clinical  study  and  study  are 
synonymous. 
 
1.8.  Compliance (in relation to studies) 
Adherence to the study protocol, relevant SOPs, Good Clinical Practice, 
and the applicable regulatory requirements. 
 
1.9.  Control Product 
Any approved product used according to label directions, or any placebo, 
used  as  a  reference  in  a  clinical  study  for  comparison  with  the 
investigational veterinary product under evaluation. 
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1.10. Contract Research Organization (CRO) 
An individual or organization contracted by the sponsor or investigator to 
perform one or more of the obligations of the sponsor or investigator. 
 
1.11. Disposal of Investigational Veterinary Products 
The  fate  of  investigational  veterinary  and  control  products  during  or 
following completion of the study.  For example, after complying with any 
restrictions  to  minimize  public  health  concerns,  the  products  may  be 
returned  to  the  sponsor,  incinerated  or  disposed  of  by  other  approved 
methods. 
 
1.12. Disposal of Study Animals 
The fate of the study animals or their edible products during or following 
completion of the study.  For example, after complying with any restrictions 
to minimize public health concerns, animals may be slaughtered, returned 
to the herd, sold or returned to their owner. 
 
1.13. Final Study Report (FSR)  
A comprehensive description of a study of an investigational veterinary 
product that is written after the collection of all raw data is complete or the 
study is discontinued and that completely describes the objectives and 
experimental  materials  and  methods  (including  statistical  analyses), 
presents the study results and contains a critical evaluation of the study 
results. 
 
1.14. Good Clinical Practice (GCP) 
A  standard  for  the  design,  conduct,  monitoring,  recording,  auditing, 
analysis,  and  reporting  of  clinical  studies.    Adherence  to  the  standard 
provides assurance that the data and reported results are complete, correct 
and accurate, that the welfare of the study animals and the safety of the 
study  personnel  involved  in  the  study  are  ensured,  and  that  the 
environment and the human and animal food chains are protected. 
 
1.15. Informed Consent 
A documented process by which an owner, or owners agent, voluntarily 
confirms the owners willingness to allow their animal(s) to participate in a 
particular study, after having been informed of all aspects of the study that 
are relevant to the decision to participate. 
 
1.16. Inspection 
The act by a relevant regulatory authority of conducting, in accordance with 
its  legal  authority,  an  official  review  of  study  documentation,  facilities, 
equipment,  finished  and  unfinished  materials  (and  associated 
documentation),  labeling,  and  any  other  resources  related  to  the 
registration of an investigational veterinary product and that may be located 
at any site related to the study. 
 
1.17. Investigational Veterinary Product 
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Any biological or pharmaceutical form of, or any animal feed containing one 
or more active substances being evaluated in a clinical study, to investigate 
any  protective,  therapeutic,  diagnostic,  or  physiological  effect  when 
administered or applied to an animal. 
 
1.18. Investigator 
An individual responsible for all aspects of the conduct of a study at a study 
site.  If a study is conducted by a group of individuals at a study site, the 
investigator is the leader of the group. 
 
1.19. Monitor 
An individual responsible for overseeing a clinical study and ensuring that it 
is conducted, recorded, and reported in accordance with the study protocol, 
Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and 
the applicable regulatory requirements. 
 
1.20. Multicenter Study 
A study conducted according to a single study protocol at more than one 
site. 
 
1.21. Quality Assurance (QA) 
A planned and systematic process established to ensure that a study is 
performed and the data are collected, documented (recorded) and reported 
in  compliance  with  this  guidance  and  the  applicable  regulatory 
requirements. 
 
1.22. Quality Control (QC) 
The  operational  techniques  and  activities  undertaken  within  the  quality 
assurance system to verify that the requirements for quality of the study-
related activities have been fulfilled. 
 
1.23. Randomization 
The process of assigning study animals (or groups of study animals) to 
treatment or control groups using an element of chance to determine the 
assignments in order to reduce bias. 
 
1.24. Raw Data 
Any original worksheets, calibration data, records, memoranda and notes of 
first-hand observations and activities of a study that are necessary for the 
reconstruction and evaluation of the study.  Raw data may include, but are 
not limited to, photographic materials, magnetic, electronic or optical media, 
information  recorded  from  automated  instruments,  and  hand-recorded 
datasheets.    Facsimile  transmissions  and  transcribed  data  are  not 
considered raw data. 
 
1.25. Regulatory Authorities 
Bodies  having  the  statutory  power  to  regulate.    In  this  guidance,  the 
expression  regulatory  authorities  includes  the  authorities  that  review 
submitted clinical data and conduct inspections. 
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1.26. Sponsor 
An  individual,  company,  institution  or  organization  which  takes 
responsibility  for  the  initiation,  management,  and  financing  of  a  clinical 
study for the veterinary product under investigation. 
 
1.27. Standard Operating Procedure (SOP) 
A detailed, written instruction to facilitate consistency in the performance of 
a specific function. 
 
1.28. Study Animal 
Any animal that participates in a clinical study, either as a recipient of the 
investigational veterinary product or as a control. 
 
1.29. Study Protocol 
A document signed and dated by the investigator and the sponsor that fully 
describes the objective(s), design, methodology, statistical considerations 
and  organization  of  a  study.    The  study  protocol  may  also  give  the 
background and rationale for the study but these could be provided in other 
study protocol-referenced documents.  Throughout this guidance the term 
study protocol includes all study protocol amendments. 
 
1.30. Study Protocol Amendment 
A written change or modification of the study protocol effected prior to the 
implementation of the protocol or execution of the changed or modified 
task.  Study protocol amendments should be signed and dated by the 
investigator and sponsor and incorporated into the study protocol. 
 
1.31. Study Protocol Deviation 
A  departure  from  the  procedures  stated  in  the  study  protocol.    Study 
protocol deviations should be recorded as a statement signed and dated by 
the investigator describing the deviation and the reason for its occurrence 
(if identifiable). 
 
1.32. Target Animal 
The specific animal by species, class and breed identified as the animal for 
which the investigational veterinary product is intended for use. 
 
1.33. Veterinary Product 
Any product with approved claims to having a protective, therapeutic or 
diagnostic effect or to affect physiological functions when administered to or 
applied  to  an  animal.    The  term  applies  to  therapeutics,  biologicals, 
diagnostics and modifiers of physiological function. 
 
2.  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.  
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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 
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encouraged  to  adopt  and  adhere  to  generally  recognized  sound  QA 
practices. 
 
3.  THE INVESTIGATOR 
 
3.1.  General. 
 
3.1.1.  The investigator is the individual responsible for all aspects of the 
conduct of the study.  These would include: the dispensing and the 
administration  of  the  investigational  and  control  veterinary 
product(s), the implementation of the study protocol, the collection 
and reporting of the study data and the protection of the health and 
welfare  of  the  personnel  involved  in  the  study  and  the  animals 
during the study. 
 
3.1.2.  The investigator should have sufficient knowledge, scientific training 
and experience, as evidenced by a current curriculum vitae and 
other  credentials,  to  conduct  clinical  studies  to  investigate  the 
effectiveness  and  in-use  safety  of  investigational  veterinary 
products in the target species.  The investigator should be familiar 
with the background and requirements of the study before taking 
receipt of the investigational veterinary product. 
 
3.1.3.  If a study is conducted by a group of individuals, the investigator is 
the leader of the group. 
 
3.1.4.  The  investigator  may  be  assisted  by  trained  competent  staff  in 
collecting, recording and the subsequent processing of data. 
 
3.1.5.  An individual should not serve as both the investigator and the 
monitor of any one study. 
 
3.2.  Responsibilities.  The investigator should: 
 
3.2.1.  Submit to the sponsor, before the study is initiated, an up-to-date 
personal curriculum vitae and other applicable credentials. 
 
3.2.2.  Agree, by signature, to the study protocol with the sponsor that the 
study will be conducted according to the study protocol following 
the principles of GCP and applicable regulatory requirements. 
 
3.2.3.  Ensure that the study is conducted according to the study protocol, 
relevant SOPs, GCP and applicable regulatory requirements. 
 
3.2.4.  Maintain in the study documentation a signed and dated copy of the 
study  protocol  which  includes  each  study  protocol  amendment.  
Each study protocol amendment, whether prepared by the sponsor 
or investigator, should be signed and dated by the sponsor and 
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investigator and should identify what has been changed or modified 
and the reasons for such change or modification. 
 
3.2.5.  Record in a signed and dated statement, to be retained in the study 
documentation,  any  deviation  from  the  study  protocol  and  the 
reason for its occurrence (if identifiable). 
 
3.2.6.  Notify the sponsor promptly of any study protocol deviation. 
 
3.2.7.  Provide sufficient qualified personnel, including (as appropriate) a 
veterinarian to attend to the study animals, for the timely and proper 
conduct  of  the  study.    Adequately  inform  and  provide  any 
necessary  training  to  personnel  involved  with  the  study  or  the 
management of the study animals to ensure compliance with the 
study protocol and applicable regulatory requirements. 
 
3.2.8.  Delegate any authority and work, including any subcontracted work, 
only to individuals qualified by training and experience to perform 
the assigned duties. 
 
3.2.9.  Provide  relevant  materials  and  information  obtained  from  the 
sponsor to the study personnel. 
 
3.2.10. Ensure that adequate and well-maintained facilities and equipment, 
whether owned or leased, are used to conduct the study. 
 
3.2.11. Utilize  Standard  Operating  Procedures  (SOPs)  for  practical 
applications as appropriate.   
 
3.2.12. Comply  with  applicable  regulatory  requirements  governing  the 
humane care of study animals. 
 
3.2.13. Obtain informed consent from each owner, or owners agent, before 
their animal(s) participate in the study.  Each owner or owners 
agent  should  receive  relevant  information  regarding  such 
participation from the investigator prior to giving their consent. 
 
3.2.14. Supervise the housing, feeding, and care of all study animals at the 
study site and inform owners of animals housed off-site of their 
obligations as stated in the study protocol. 
 
3.2.15. Document any veterinary care and procedures, changes in animal 
health, or significant environmental changes. 
 
3.2.16. Comply with the study protocol regarding the use of edible products 
derived from food-producing animals treated with an investigational 
and control veterinary product(s) and the proper disposal of study 
animals. 
 
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3.2.17. Promptly notify the sponsor of adverse events (AEs). 
 
3.2.18. Manage  any  code  procedure  and  documentation  (e.g. 
randomization  envelopes,  blinding  information)  with  professional 
care  and  ensure  that  any  treatment  code  is  only  broken  in 
accordance  with  the  study  protocol  and  with  the  sponsors 
knowledge and consent.  Study personnel who can not be or are 
not blinded (masked) should participate in the conduct of the study 
to the minimum extent necessary. 
 
3.2.19. Be responsible for the receipt, control, storage, distribution, and 
further mixing with subsequent assay (if any) of the investigational 
and  control  veterinary  product(s)  shipped  or  delivered  to  the 
investigator for the conduct of the study. 
 
3.2.20. Provide  secure  storage  of,  and  control  the  access  to  the 
investigational and control veterinary product(s) in accordance with 
the study protocol and label specifications. 
 
3.2.21. Maintain a full inventory of receipt, usage, assay results for the 
investigational and control veterinary product(s) in feed or water (if 
further mixing by the investigator is required) and any remaining 
stocks of unused investigational and control veterinary product(s). 
 
3.2.22. Ensure that the investigational and control veterinary product(s) are 
dispensed and administered to study animals in accordance with 
the study protocol. 
 
3.2.23. Not redistribute the investigational and control veterinary product(s) 
to any individual not authorized to receive them. 
 
3.2.24. At  the  end  of  the  study,  reconcile  delivery  records  of  the 
investigational and control veterinary product(s) with those of usage 
and returns including accounting for any discrepancies. 
 
3.2.25. When the study is completed or discontinued, be responsible for 
and  adequately  document  the  safe  and  final  disposal  of  the 
investigational and control veterinary product(s), including animal 
feed containing the investigational or control veterinary product(s).  
This may be achieved by return to the sponsor or other appropriate 
means of disposal. 
 
3.2.26. Collect and retain the study documentation. 
 
3.2.27. Document  unanticipated  events  that  may  affect  the  quality  and 
integrity of the study when they occur and any corrective action 
taken. 
 
3.2.28. Collect and record data, including unanticipated observations, in 
accordance  with  the  study  protocol  and  applicable  regulatory 
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requirements  in  an  unbiased  manner  that  accurately  and 
completely reflects the observations of the study. 
 
3.2.29. Prepare  and  maintain  an  accurate  and  complete  record  of  all 
contacts  including  all  telephone  calls,  visits,  letters,  and  other 
contacts  with  representatives  of  the  sponsor,  representatives  of 
relevant regulatory authorities and other personnel (e.g., contract 
research organization personnel) concerning the design, conduct, 
documentation, and reporting of the study.  A contact record should 
include: the date and time of the contact; the nature of the contact; 
the name and organizational affiliation of all individuals involved; a 
summary  of  the  purpose  of  the  contact  and  subject  matter 
discussed with sufficient detail to describe the basis of any actions 
that may be taken by the investigator and/or the sponsor as a result 
of the contact. 
 
3.2.30. Ensure that all specimens required to be retained by the study 
protocol and any applicable regulatory requirements are identified 
in a manner that is complete, accurate, legible and precludes loss 
of identification from the specimen. 
 
3.2.31. Securely store, protected from deterioration, destruction, tampering, 
or vandalism, all study documentation or authenticated copies of 
study documentation required to be retained by the investigator for 
the period of time required by the relevant regulatory authorities. 
 
3.2.32. Provide  to  the  sponsor  on  request  either  the  signed  study 
documentation or an authenticated copy.  When all or part of the 
study documentation is forwarded to the sponsor, an authenticated 
copy  of  the  forwarded  information  should  be  retained  by  the 
investigator. 
 
3.2.33. Participate, when applicable, in the preparation of the final study 
report. 
 
3.2.34. Permit monitoring and quality auditing of a clinical study. 
 
3.2.35. Permit the relevant regulatory authority to inspect the facilities used 
by the investigator for the study and to inspect and copy any or all 
of the study documentation made or kept by the investigator as part 
of or pertaining to the study for the purpose of verifying the validity 
of the data. 
 
4.  THE SPONSOR 
 
4.1.  General.  An individual, company, institution or organization which takes 
responsibility  for  the  initiation,  management,  and  financing  of  a  clinical 
study for the veterinary product under investigation. 
 
4.2.  Responsibilities.  The sponsor should: 
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4.2.1.  Ascertain that sufficient scientifically valid information exists with 
respect  to  the  effectiveness  and  safety  of  the  investigational 
veterinary  product  to  justify  conduct  of  the  clinical  study.  The 
sponsor should also determine from this information that there are 
no environmental, animal welfare, or scientific grounds which might 
preclude the conduct of a clinical study. 
 
4.2.2.  Ensure that notification or application relating to the conduct of the 
study  has  been  submitted  to  the  regulatory  authorities  where 
required. 
 
4.2.3.  Select the investigator(s) and assure their qualifications, determine 
their availability for the entire duration of the study, confirm that they 
agree to undertake the study in accordance with an agreed study 
protocol, GCP and applicable regulatory requirements. 
 
4.2.4.  Appoint appropriately qualified and trained monitor(s). 
 
4.2.5.  Arrange,  as  necessary,  for  the  preparation  of  SOPs  for  the 
procedural and technical elements of the study. 
 
4.2.6.  Prepare a study protocol, in consultation with the investigator as 
appropriate,  giving  due  regard  to  the  above  considerations  and 
consistent with the principles for GCP. 
 
4.2.7.  Sign,  along  with  the  investigator,  the  study  protocol  as  an 
agreement that the clinical study will be conducted according to the 
study protocol.  Any amendments to the study protocol should have 
the signed agreement of both sponsor and investigator. 
 
4.2.8.  Ensure, for multicenter studies, that: 
 
4.2.8.1. All investigators conduct the study in strict compliance with 
the study protocol agreed to by the sponsor and if required, 
by the regulatory authority. 
 
4.2.8.2. The data capture system is designed to capture the required 
data at all multicenter study sites.  For those investigators 
who are collecting additional data requested by the sponsor, 
supplemental data capture systems should be provided and 
designed to capture the additional data. 
 
4.2.8.3. All investigators are given uniform instructions on following 
the  study  protocol,  on  complying  with  a  uniform  set  of 
standards  for  the  assessment  of  clinical  and  laboratory 
findings and on capturing data. 
 
4.2.8.4. Communication between investigators is facilitated. 
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4.2.9.  Inform  the  investigator  of  appropriate  chemical,  pharmaceutical, 
toxicological, safety, effectiveness and other relevant information as 
a prerequisite to conducting the study.  The sponsor should also 
inform  the  investigator  of  any  such  pertinent  information  that 
becomes available during the study and when required, ensure that 
the relevant regulatory authority is also notified. 
 
4.2.10. Report  all  AEs  in  accordance  with  applicable  regulatory 
requirements. 
 
4.2.11. Ensure the proper disposal of all study animals and any edible 
products derived from them according to the applicable regulatory 
requirements. 
 
4.2.12. Ensure  that  the  investigational  and  control  veterinary  product(s) 
have  been  prepared,  labeled  and  shipped  according  to 
requirements of the relevant regulatory authority. 
 
4.2.13. Prepare  and  retain  records  of  shipment  of  the  investigational 
veterinary and control product(s).  When the study is completed or 
discontinued, ensure the proper and final disposal of all supplies of 
the investigational and control veterinary product(s) and any animal 
feed containing the investigational or control veterinary product. 
 
4.2.14. Maintain  study  documentation,  protected  from  deterioration, 
destruction, tampering or vandalism, for as long as required to fulfill 
applicable regulatory requirements in the countries where the study 
has  been  submitted  in  support  of  the  registration  of  the 
investigational veterinary product. 
 
4.2.15. In  the  event  that  an  animal  is  treated  with  an  investigational 
veterinary product, arrange for a study report to be written whether 
or not the study has been completed as planned. 
 
4.2.16. Ensure the quality and integrity of data from clinical studies by 
implementing quality audit procedures that are consistent with well-
recognized and accepted principles of quality assurance. 
 
4.2.17. Comply with the applicable regulatory requirements governing the 
humane care of study animals. 
 
4.3.  Delegations to a CRO. 
 
4.3.1.  A sponsor may delegate any or all of the sponsors study-related 
duties and functions to a CRO, but the ultimate responsibility for the 
quality  and  integrity  of  the  study  data  always  resides  with  the 
sponsor. 
 
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4.3.2.  Any  study-related  duty  or  function  that  is  delegated  to  a  CRO 
should be specified in writing. The sponsor should notify the CRO 
of  its  responsibility  to  comply  with  applicable  regulatory 
requirements. 
 
4.3.3.  Any study-related duties or functions not specifically delegated to a 
CRO are retained by the sponsor. 
 
4.3.4.  All references to a sponsor in this guidance also apply to a CRO to 
the extent that a CRO has assumed the study-related duties and 
functions of a sponsor. 
 
5.  THE MONITOR 
 
5.1.  General.  An individual appointed by the sponsor to be responsible to the 
sponsor for monitoring and reporting on progress of the study, verifying the 
data  and  confirming  that  the  clinical  study  is  conducted,  recorded  and 
reported in compliance with GCP and applicable regulatory requirements.  
The  monitor  should  have  scientific  training  and  experience  to 
knowledgeably oversee a particular study.  The monitor should be trained 
in quality control techniques and data verification procedures.  The monitor 
should  understand  all  applicable  protocol  requirements  and  be  able  to 
determine  whether  the  study  was  conducted  in  accordance  with  the 
protocol and relevant SOPs.  An individual should not serve as both the 
monitor and investigator for any one study.  The monitor is the principal 
communication link between the sponsor and the investigator. 
 
5.2.  Responsibilities.  The monitor should: 
 
5.2.1.  Assist the sponsor to select the investigator when requested. 
 
5.2.2.  Be  reasonably  available  to  the  investigator  for  consultation  in 
person, by telephone or by other means. 
 
5.2.3.  Determine that the investigator and staff have sufficient time to 
devote  to  the  study.    Also,  determine  that  the  study  site  has 
adequate  space,  facilities,  equipment  and  staff  and  that  an 
adequate number of study animals is likely to be available for the 
duration of the study. 
 
5.2.4.  Confirm that the study staff has been adequately informed about 
the details of the study. 
 
5.2.5.  Ensure that the investigator accepts responsibility for conducting 
the study and in so doing understands: the investigational status of 
the veterinary product under evaluation; the nature and details of 
the  study  protocol;  the  applicable  regulatory  requirements 
governing the humane care of study animals; the conditions of any 
authorization  for  the  use  of  edible  products  derived  from  food-
producing  animals  treated  with  the  investigational  or  control 
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veterinary product(s) and any other applicable restrictions on the 
disposal or subsequent use of study animals. 
 
5.2.6.  Work according to the sponsors requirements, visit the investigator 
with  sufficient  frequency  before,  during  and  after  the  study  to 
control  adherence  to  the  study  protocol,  GCP  and  applicable 
regulatory requirements. 
 
5.2.7.  Not, in any way, bias the data collection process or outcome of the 
study, other than to ensure that the current study protocol, relevant 
SOPs,  GCP,  and  applicable  regulatory  requirements  are  being 
followed.  
 
5.2.8.  Ensure that informed consent is obtained and recorded from the 
owner(s) or owners agents prior to their animals participating in the 
study. 
 
5.2.9.  Ensure that all data are correctly and completely recorded. 
 
5.2.10. Ensure that illegible, missing or corrected study documentation is 
fully explained. 
 
5.2.11. Confirm  that  the  storage,  dispensing  and  documentation  of  the 
supply of the investigational and control veterinary product(s) are 
safe and appropriate and ensure that any unused products are 
returned by the investigator to the sponsor or disposed of properly. 
 
5.2.12. Review the raw data and other study documentation necessary to 
determine  that  the  study  protocol  is  being  followed  and  the 
information maintained or kept by the investigator is accurate and 
complete. 
 
5.2.13. Prepare  and  maintain  an  accurate  and  complete  record  of  all 
contacts  including  all  telephone  calls,  visits,  letters  and  other 
contacts  with  the  investigator,  representatives  of  the  sponsor, 
representatives  of  relevant  regulatory  authorities  and  other 
personnel  (e.g.,  contract  research  organization  personnel) 
concerning the design, conduct, documentation, and reporting of 
the study.  A contact record should include:  the date and time of 
the contact; the nature of the contact; the name, and organizational 
affiliation of all individuals involved; a summary of the purpose of 
the contact and subject matter discussed with sufficient detail to 
describe  the  basis  of  any  actions  that  may  be  taken  by  the 
investigator and/or the sponsor as a result of the contact. 
 
5.2.14. Confirm  investigator  compliance  to  the  principles  of  GCP  by 
providing a signed and dated summary report of the contacts, visits 
made and activities witnessed during the conduct of the study.  This 
summary report should be submitted to the sponsor at the end of 
the study. 
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6.  THE STUDY PROTOCOL 
 
6.1.  General. 
 
6.1.1.  A study protocol is a document that states the objectives of the 
study and defines the conditions under which the study is to be 
performed and managed. 
 
6.1.2.  A  well-designed  study  relies  predominantly  on  a  thoroughly 
considered,  well-structured  and  comprehensive  protocol  which 
should be completed and approved by the sponsor and investigator 
before the study is initiated. 
 
6.1.3.  A comprehensive study protocol that is easily understood by the 
investigator  executing  the  study  and  by  the  relevant  regulatory 
authority reviewing the protocol and study results may facilitate the 
registration process for veterinary products. 
 
6.2.  Study Protocol Review.  Review of the study protocol by the relevant 
regulatory authority prior to the initiation of the clinical study is encouraged 
within the principles of GCP particularly when there is any uncertainty about 
a proposed study design or there are differing opinions about the relevance 
of several options for conducting the study.  Review of the study protocol by 
the relevant regulatory authority does not bind the authority to accept the 
data  collected  from  a  study  conducted  using  such  a  study  protocol.  
However, it is expected that both the sponsor and the relevant regulatory 
authority  would  benefit  from  such  a  review,  in  terms  of  a  mutual 
understanding  of  the  regulatory  requirements  and  the  relevance  of  the 
objective(s) of the study protocol. 
 
6.3.  Study  Protocol  Check  List.    The  study  protocol  should  contain  the 
information  given  in  the  following  list  of  items  or  this  list  should  be 
considered whenever a study is contemplated.  The list provided is not 
exhaustive nor is every item included applicable to all study protocols but it 
is intended to give guidance: 
 
6.3.1.  Title of the study. 
 
6.3.2.  Identifier unique to the study.  A unique identifier consists of a 
study protocol number, the status of the study protocol (i.e., draft, 
final, amended) and the date of the version of the study protocol, all 
of which should be clearly located on the title page. 
 
6.3.3.  Study  contacts.    Study  contacts  include  the  investigator, 
representatives of the sponsor and all other participants responsible 
for major aspects of the study.  List, for each contact, the title, 
qualifications,  professional  background,  as  well  as  the  postal 
address telephone number and other communication means. 
 
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6.3.4.  Identity  of  the  sites  (if  known  at  the  time  of  study  protocol 
preparation). 
 
6.3.5.  Objective(s)/purpose of the study. 
 
6.3.6.  Justification.    Describe  all  information  where  relevant  to  the 
understanding of the objective of the study (pre-clinical or clinical 
data published or otherwise available) that justifies the conduct of 
the clinical study. 
 
6.3.7.  Schedule of events.  Schedule of key events occurring during the 
animal phase of the study including: the expected date and time of 
commencement of the animal phase, the period during which the 
investigational  and  control  veterinary  product(s)  are  being 
administered,  the  post  administration  observation  period,  the 
withholding  period  (when  applicable)  and  the  termination  date 
where known. 
 
6.3.8.  Study design.  Describe: 
 
6.3.8.1.  The  overall  design  of  the  study,  e.g.  a  placebo  control 
clinical field effectiveness study or a randomized blocked 
design versus a positive control, with blinding. 
 
6.3.8.2.  The  treatment,  if  any,  in  detail  to  be  applied  to  control 
group(s) or for control period(s). 
 
6.3.8.3.  The randomization method, including the procedures to be 
adopted  and  practical  arrangements  to  be  followed  to 
allocate animals to treatment groups and treatment groups 
to experimental units. 
 
6.3.8.4.  The experimental unit(s) and justify their selection. 
 
6.3.8.5.  The extent and methods of blinding (masking) and other 
bias  reducing  techniques  to  be  used  and  state  the 
provisions, including procedures and personnel, for access 
to treatment codes. 
 
6.3.9.  Animal selection and identification.  Specification of the source, 
number, identity and type of study animal to be used, such as 
species, age, gender, breed category, weight, physiological status 
and prognostic factors. 
 
6.3.10. Inclusion/exclusion  and  post-inclusion  removal  criteria.  
Specify objective criteria for the exclusion from, inclusion in and 
removal subsequent to inclusion in the study. 
 
6.3.11. Animal management and housing.  Describe: 
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6.3.11.1. The containment of the study animals, e.g. pens, kennels, 
pastures. 
 
6.3.11.2. Space  allocation  per  animal  (in  comparison  to  standard 
management practices). 
 
6.3.11.3. The  thermoregulation  (heating/cooling)  and  ventilation  of 
animal accommodation. 
 
6.3.11.4. Permissible  and  non-permissible  concomitant  veterinary 
care and therapy. 
 
6.3.11.5. The management of feed (including pasture management 
and the preparation and storage of mixed feeds) and water 
(including  supply,  availability  and  quality)  and  their 
presentation to the study animals. 
 
6.3.12. Animal  feeds.    Authoritative  reference  sources  may  serve  as 
useful guides in the determination of the nutritional requirements of 
the  study  animals  and  preparation  of  feeds.    The  ration-related 
study  documentation  should  be  sufficient  to  establish  that  the 
nutritional  requirements  of  the  animals  are  met  so  as  not  to 
compromise the objectives of the study and to ensure that animal 
welfare  requirements  are  met.    Where  nutritional  status can  be 
critical to the measurements to be collected in the study, detailed 
records of feed characteristics should be collected.  As appropriate: 
 
6.3.12.1. Determine  the  nutrient  needs  of  the  study  animals  and 
prepare feeds meeting these needs. 
 
6.3.12.2. Provide quantitative composition (e.g., feedstuffs, vitamins, 
minerals  and,  as  appropriate,  permissible  feed  additives) 
and calculated nutrient densities for all feeds used in the 
study. 
 
6.3.12.3. Describe procedures for the sampling of the feed used in the 
study  and  subsequent  analysis  of  these  samples  for 
selected nutrients. 
 
6.3.12.4. Develop and follow objective criteria to determine whether 
feeds used in the study, based on actual laboratory nutrient 
analyses, meet the pre-determined calculated requirements. 
 
6.3.12.5. Provide a feeding program (feeding schedule). 
 
6.3.12.6. Collect records of the amount of feed offered and refused. 
 
6.3.13. Investigational veterinary and control product(s). 
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6.3.13.1. Clearly and precisely identify the investigational veterinary 
product to readily permit an unambiguous determination of 
the specific formulation.  Instructions for the further mixing (if 
any), packaging and storage of these products should be 
stated. 
 
6.3.13.2. If the investigational veterinary product is administered in 
feed or water, describe the procedures for determining the 
concentration of the investigational veterinary product in the 
feed or water, including the sampling methods and assay 
methodologies  (e.g.  laboratory  used,  analytical  method, 
number  of  replicates,  assay  limits,  permitted  analytical 
variation) to be used.  Develop and follow objective criteria 
to determine whether the investigational veterinary product 
concentration in the feed or water is adequate. 
 
6.3.13.3. Identify control products by generic or trade name; dosage 
form,  formulation  (ingredients);  concentration;  batch 
number;  expiry  date.    Store  and  use  these  products 
according to label directions. 
 
6.3.14. Treatments.    For  the  investigational  and  control  veterinary 
product(s): 
 
6.3.14.1. Justify the dosing to be used. 
 
6.3.14.2. Describe the dosing regimen (route, site of injection, dose, 
frequency and duration of administration) to be followed in 
administering the products. 
 
6.3.14.3. Specify objective criteria for the potential use of concomitant 
veterinary treatment. 
 
6.3.14.4. Describe the methods and precautions to be taken to ensure 
the safety of study personnel handling these products prior 
to and during administration. 
 
6.3.14.5. Describe  measures  to  ensure  administration  of  these 
products  in  compliance  with  the  study  protocol  or  its 
labeling. 
 
6.3.15. Disposal  of  study  animals,  products  of  study  animals  and 
investigational and control veterinary product(s). 
 
6.3.15.1. Describe the proposed disposal of the study animals. 
 
6.3.15.2. Describe the care to be given to animals removed from the 
study in accordance with pre-established criteria. 
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6.3.15.3. State the conditions for use of edible products from food-
producing animals that must be followed in order to comply 
with  the  authorization  granted  by  the  relevant  regulatory 
authority. 
 
6.3.15.4. Describe the proposed disposal of the investigational and 
control veterinary product(s). 
 
6.3.16. Assessment of effectiveness. 
 
6.3.16.1. Define  the  effects  to  be  achieved  and  the  clinical  end-
point(s) to be reached before effectiveness can be claimed. 
 
6.3.16.2. Describe  how  such  effects  and  end-points  are  to  be 
measured and recorded. 
 
6.3.16.3. Specify the timing and frequency of study observations. 
 
6.3.16.4. Describe the special analyses and/or tests to be performed, 
including  the  time  of  sampling  and  the  interval  between 
sampling, storage of samples, and the analysis or testing. 
 
6.3.16.5. Select and define any scoring system and measurements 
that  are  necessary  to  objectively  measure  the  targeted 
response(s) of the study animal and evaluate the clinical 
response. 
 
6.3.16.6. Define the methods for computing and calculating the effect 
of the investigational veterinary product. 
 
6.3.17. Statistics/Biometrics.    Thoroughly  describe  the  statistical 
methodologies  to  be  used  to  evaluate  the  effectiveness  of  the 
investigational veterinary product, including the hypotheses to be 
tested,  the  parameters  to  be  estimated,  the  assumptions  to  be 
made, and the level of significance, the experimental unit and the 
statistical model to be used.  The planned sample size should be 
justified in terms of the target animal population, the power of the 
study and pertinent clinical considerations. 
 
6.3.18. Handling  of  records.    Specify  procedures  for  recording, 
processing,  handling,  and  retaining  raw  data  and  other  study 
documentation required by the relevant regulatory authority. 
 
6.3.19. Adverse events.  Describe procedures for: 
 
6.3.19.1. Observing study animals with sufficient frequency to detect 
AEs. 
 
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6.3.19.2. Taking appropriate actions in response to observed AEs.  
Appropriate  actions  may  involve,  among  other  items, 
locating  and  breaking  blinding  codes  so  that  appropriate 
medical treatment can be given. 
 
6.3.19.3. Recording of the AEs in the study documentation. 
 
6.3.19.4. Reporting AEs to the sponsor. 
 
6.3.20. Supplements to be appended to the protocol. 
 
6.3.20.1. List  any  study-specific  SOPs  that  apply  to  the  conduct, 
monitoring and reporting of the study. 
 
6.3.20.2. Attach a copy of all data capture and event record forms to 
be used during the study. 
 
6.3.20.3. Include any other relevant supplements, e.g. information to 
be provided to the owners of animals, instructions to study 
personnel. 
 
6.3.21. Changes to the study protocol.  Instructions for preparation of 
amendments  and  reporting  of  deviations  to  the  study  protocol 
should be provided. 
 
6.3.22. References.  Provide citations to relevant literature referenced in 
the study protocol. 
 
7.  THE FINAL STUDY REPORT 
 
7.1.  General. 
 
7.1.1.  The  final  study  report  (FSR)  is  a  complete  and  comprehensive 
description of the study written after its completion.  It includes a 
description  of  the  materials  and  methods,  a  presentation  and 
evaluation of the results, statistical analyses and a critical clinical, 
scientific and statistical appraisal.  The report should follow the 
format of the study protocol. 
 
7.1.2.  The sponsor should provide a FSR for any study in which an animal 
has been treated with an investigational veterinary product whether 
or not the study has been completed as planned. 
 
7.2.  Authorship. 
 
7.2.1.  The preparation of this report can be accomplished as follows: 
 
7.2.1.1.  The sponsor may prepare the FSR; 
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7.2.1.2.  The investigator may prepare the FSR for the sponsor; or 
 
7.2.1.3.  The sponsor and investigator may prepare the FSR through 
a collaborative effort. 
 
7.2.2.  All individuals involved in the preparation of the FSR would be 
considered author(s). 
 
7.2.3.  When  an  investigator  relinquishes  authorship  of  the  FSR,  the 
investigator should provide to the authors: 
 
7.2.3.1.  All necessary study documentation specific to the site at 
which the investigator conducted the study, and 
 
7.2.3.2.  A signed and dated document, to be included in the FSR, 
which  adequately  describes  the  study  documentation 
provided to the author(s) and attests to the accuracy and 
completeness of the documentation provided. 
 
7.2.4.  The authors of the FSR should sign and date the report.  Authors of 
the FSR should be aware that the regulatory authorities view these 
signatures  as  an  affirmation  that  all  data  were  collected  in 
compliance  with  the  study  protocol,  relevant  SOPs,  GCP  and 
applicable  regulatory  requirements,  and  that  all  statements  are 
accurate  and  complete  representations  of  study  activities  and 
results  and  are  fully  supported  by  the  study  documentation.  
Therefore, the authors may wish to include in the report a brief 
statement describing their contributions to the report. 
 
7.3.  Content  of  Final  Study  Report.    The  FSR  should  include  relevant 
information from the following list.  The list provided is not exhaustive nor is 
every  item  included  applicable  to  all  FSRs,  but  it  is  intended  to  give 
guidance.    The  study  protocol  section  should  be  consulted  for  an 
explanation of the items in this list. 
 
7.3.1.  Title and identifier of the study. 
 
7.3.2.  Objectives of the study. 
 
7.3.3.  The  titles,  names,  qualifications  and  roles  of  all  people 
involved in conducting key elements of the study. 
 
7.3.4.  The identity of the site(s) at which the study was conducted. 
 
7.3.5.  Key study dates. 
 
7.3.6.  Materials and methods. 
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7.3.6.1.  Study design. 
 
7.3.6.2.  Animal selection and identification. 
 
7.3.6.2.1.  Full details of study animals in each group, including 
but not limited to: numbers, breed, age, gender and 
physiological status. 
 
7.3.6.2.2.  Disease history of the animals, where available and 
if  appropriate,  relevant  to  the  condition  under 
investigation,  especially  in  the  case  of  specific 
disease problems associated with an animal unit. 
 
7.3.6.2.3.  Where appropriate, diagnosis of the condition being 
treated or prevented, including a description of the 
clinical signs or other diagnostic methods according 
to conventional criteria. 
 
7.3.6.2.4.  Detailed inclusion and exclusion criteria applied to 
the selection of study animals. 
 
7.3.6.2.5.  Full  information  on  any  study  animal  removed 
subsequent to inclusion in the study. 
 
7.3.6.3.  Animal management and housing. 
 
7.3.6.3.1.  Details of animal housing and management. 
 
7.3.6.3.2.  Composition of feed and the nature and quantity of 
any additives in the feed. 
 
7.3.6.3.3.  Details of any concomitant treatment administered 
during  the  study,  either  prior  to,  during  or  after 
treatment  with  the  investigational  veterinary  or 
control  product(s),  and  details  of  any  interactions 
observed. 
 
7.3.6.4.  Animal disposal.  A summary of the disposal of the study 
animals and their edible products. 
 
7.3.6.5.  Treatments. 
 
7.3.6.5.1.  The  identification  of  the  study  investigational 
formulation  used  in  the  study,  including  strength, 
purity,  composition,  quantity,  and  batch  or  code 
mark. 
 
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7.3.6.5.2.  The dosage of the investigational veterinary product, 
method, route and frequency of administration, and 
precautions, if any, taken during administration. 
 
7.3.6.5.3.  Details  of  the  control  product(s)  used  with  a 
justification for their selection. 
 
7.3.6.5.4.  The duration of treatment and observation periods. 
 
7.3.6.5.5.  A summary of use and disposal of all investigational 
veterinary product and control product(s) shipped or 
delivered to the investigator. 
 
7.3.6.6.  Study procedures.  A full description of the methods used 
including, if applicable, assay methods used to determine 
investigational  veterinary  product  concentration  in  feed, 
water, body fluids and tissues. 
 
7.3.6.7.  Statistical methods.  A description of the transformations, 
calculations or operations performed on the raw data and 
any statistical methods employed to analyze the raw data. 
Reasons  should  be  given  if  the  statistical  methods  used 
differed from those proposed in the study protocol. 
 
7.3.7.  Results and their evaluation.  A full description of the results of 
the study, whether favorable or unfavorable, including tables of all 
data recorded during the study. 
 
7.3.8.  Conclusions based on each individual case or treatment group 
as appropriate. 
 
7.3.9.  Administrative and compliance items. 
 
7.3.9.1.  A description of the procedures used to record, process, 
handle and retain raw data and other study documentation. 
 
7.3.9.2.  A  description  of  any  protocol  deviations  and/or 
amendments,  and  an assessment  of  their impact  on  the 
outcome of the study. 
 
7.3.9.3.  A description of circumstances that could have affected the 
quality or integrity of the data, specifying the time frame and 
the extent of their occurrence. 
 
7.3.9.4.  Details  of  any  AEs  occurring  during  the  study  and  any 
measures taken in consequence.  For all studies where no 
AE was observed or recorded, a statement to this effect 
should be included in the FSR. 
 
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7.3.9.5.  The location of all study documentation. 
 
7.3.10. Additional  information.    Additional  information  such  as  the 
following  may  be  included  in  the  body  of  the  report  or  as  an 
appendix: 
 
7.3.10.1. Study protocol 
 
7.3.10.2. Dates of monitoring visits 
 
7.3.10.3. Audit certification by auditor, consisting of the dates of site 
visits,  audits  and  when  reports  were  provided  to  the 
sponsor. 
 
7.3.10.4. Supplementary reports, e.g. analytical, statistical, etc. 
 
7.3.10.5. Copies  of  study  documentation  supporting  study 
conclusions 
 
7.4.  Report Amendments.  Any addition, deletion, or correction to the FSR 
should be in the form of an amendment by the authors.  The amendment 
should clearly identify that part of the FSR that is being added, deleted or 
corrected and the reasons for the change(s), and should be signed and 
dated by the authors.  Minor errors, e.g., typographical errors, noted after 
finalization  of  the  report  may  be  indicated  directly  on  the  FSR  when 
accompanied by the signature or initials of the authors, the date of the 
change and the reason for the change. 
 
8.  STUDY DOCUMENTATION 
 
8.1.  General. 
 
8.1.1.  Study documentation consists of those records that individually and 
collectively permit evaluation of the conduct of the study and the 
quality  of  the  data  produced.    Filing  study  documentation,  or 
authenticated copies thereof, at the investigator and sponsor sites 
in a timely manner can greatly assist in the successful management 
of a study by the investigator and sponsor. 
 
8.1.2.  All study documentation should be retained for the period of time 
required by relevant regulatory authorities.  Any or all of the study 
documentation described in this guidance is subject to, and should 
be  available  for,  monitoring  on  behalf  of  the  sponsor.    Study 
documentation should be audited by the sponsors quality audit 
procedures,  consistent  with  well-recognized  and  accepted 
principles of quality assurance.  When a quality audit is conducted, 
the auditor should prepare a report for the sponsor which details the 
auditing  process  and  which  certifies  that  the  audit  has  been 
conducted. 
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8.1.3.  Any or all of the study documentation described in this guidance 
may be inspected, audited and copied by the relevant regulatory 
authority as part of the process to confirm the validity of the study 
conduct and the integrity of the data collected. 
 
8.1.4.  The  requirements  for  the  submission  of  study  documentation 
should be governed by the relevant regulatory authority. 
 
8.2.  Categories  of  study  documentation.    Study  documentation  should 
include, but is not limited to: 
 
8.2.1.  Study protocol.  This documentation consists of the original study 
protocol,  all  protocol  amendments  and  records  of  all  protocol 
deviations. 
 
8.2.2.  Raw data.  The raw data of a study generally includes several 
classes  of  data.    Neither  the  classes  below  nor  the  examples 
provided for each class are intended to be all-inclusive. 
 
8.2.2.1.  Animal  records.    All  pertinent  data  relating  to  the  study 
animals,  such  as:  purchase  records,  documentation  of 
animal exclusion from, inclusion in and removal subsequent 
to inclusion in the study, informed consent of the owner, 
treatment assignment, all recorded observations (including 
analytical assay results of biological samples), case report 
forms,  adverse  events,  animal  health  observations, 
composition and nutrient assay of animal feeds and final 
animal disposal. 
 
8.2.2.2.  Investigational and control veterinary product records.  All 
pertinent records of the ordering, receipt, inventory, assay, 
use or administration (documenting the dosing regimen, e.g. 
dose,  rate,  route,  and  duration  of  administration),  return, 
and/or  disposal  of  all  the  investigational  and  control 
veterinary product(s) including any animal feed containing 
the investigational or control veterinary product. 
 
8.2.2.3.  Contact records.  The monitors and investigators records of 
all contacts (e.g. visits, telephone, written and electronic) 
relating  to  the  design,  conduct,  documentation,  and 
reporting of a study. 
 
8.2.2.4.  Facility  and  equipment  records.    As  appropriate, 
descriptions  of  the  study  site,  e.g.  diagrams  and 
photographs,  equipment  identification  and  specifications, 
equipment calibration and maintenance records, equipment 
failure  and  repair  records,  meteorological  records  and 
environmental observations. 
 
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8.2.3.  Reports.  Reports consist of: 
 
8.2.3.1.  Safety reports.  Reports of adverse events. 
 
8.2.3.2.  Final study report. 
 
8.2.3.3.  Other  reports.    For  example,  statistical,  analytical,  and 
laboratory reports. 
 
8.2.4.  Standard operating procedures and reference materials.  These 
include any reference materials and SOPs related to key elements 
of the study. 
 
8.3.  Recording and handling study documentation. 
 
8.3.1.  Raw data, whether handwritten or electronic, should be attributable, 
original,  accurate,  contemporaneous  and  legible.    Attributable 
means the raw data can be traced by signature (or initials) and date 
to the individual who observed and recorded the data.  If more than 
one individual observes or records the raw data, that fact should be 
reflected in the data entries.  In automated data collection systems, 
the individual(s) responsible for direct data input should record their 
name along with the date at the time of data input.  Original and 
accurate  means  the  raw  data  are  the  firsthand  observations.  
Contemporaneous means the raw data are recorded at the time of 
observation.    Legible  means  the  raw  data  are  readable  and 
recorded in a permanent medium, e.g. ink for written records or 
electronic records that are unalterable. 
 
8.3.2.  Raw data should be maintained in an organized manner and, where 
appropriate, should be recorded in a bound laboratory notebook or 
on  pre-established  forms  designed  specifically  for  recording 
particular observation(s).  Records should be diligently completed 
with  all  data  points  recorded  as  required  in  the  study  protocol.  
When  additional  observations  are  warranted,  e.g.  to  provide 
additional information for pre-planned observations or observation 
of  unanticipated  events,  such  observations  should  also  be 
recorded.  
 
8.3.3.  Units used to measure observations should always be stated and 
transformation  of  units  should  always  be  indicated  and 
documented.    Values  of  laboratory  analyses  should  always  be 
recorded on a record sheet or attached to it.  If available, normal 
reference values for the laboratory analyzing the specimens should 
be included. 
 
8.3.4.  If a portion of the raw data needs to be copied or transcribed for 
legibility, an authenticated copy of that data should be made.  The 
reason for the copying or transcription should be explained in a 
dated  memorandum  or  in  a  dated  notation  on  the  transcribed 
record, signed by the individual(s) making the copy or transcription.  
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In such a case the copied raw data, the copy or transcript of the raw 
data and the memorandum should be kept together in the study 
documentation. 
 
8.3.5.  Any correction in the hand-written study documentation should be 
made by drawing one straight line through the original entry.  The 
original  entry  should  still  be  legible.    The  correction  should  be 
initialed and dated by the individual(s) making the correction at the 
time the correction is made and should describe the reason for the 
change. 
 
8.3.6.  Similarly, if data are entered directly into a computer system, the 
electronic  record  is  considered  the  raw  data.    A  computerized 
system should ensure that the methods for record keeping and 
retention afford at least the same degree of confidence as that 
provided with paper systems.  For example, each entry, including 
any change, should be made under the electronic signature of the 
individual making the entry, and any changes that are made to data 
stored on electronic media should be maintained in an audit trail to 
protect the authenticity and integrity of the electronic records. 
 
8.4.  Retention of study documentation. 
 
8.4.1.  All study documentation should be stored in a manner that protects 
it  from  deterioration,  destruction,  tampering  or  vandalism  in 
accordance with the nature of the records.  The storage site should 
permit  the  orderly  storage  and  easy  retrieval  of  the  retained 
documentation. 
 
8.4.2.  The location of the study documentation, and any authenticated 
copy, for a study should be specified in the final study report. 
 
8.4.3.  All  study  documentation  should  be  retained  for  an  appropriate 
period of time to satisfy the requirements of the relevant regulatory 
authorities to which the study may be or has been submitted in 
support of the registration of the investigational veterinary product. 
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