Duke University
Durham, North Carolina 27705
Office of Animal Welfare Assurance Voice: 919.668.6720
Campus Mail: Hock Plaza Box 2724 Fax: 919.668.6725
US Mail: 2424 Erwin Road; Suite 606; Durham, NC 27705 http://vetmed.duhs.duke.edu
The Duke University Animal Care & Use Program is committed to advancing healthcare for humans and animals
through compassionate care and progressive animal use.
RESEARCH ANIMAL COORDINATOR CERTIFICATION
Program Overview
The Duke Animal Care and Use Program offers a training and certification program for individuals
wishing to serve as their laboratory ‘go-to’ person for animal care and use activities. Referred to as the
Research Animal Coordinator Certification (RACC) Program, individuals who participate in this program
will receive specific and detailed information concerning animal care and use at Duke. Those who
achieve certification may be designated by the Principal Investigator to serve as the laboratory
coordinator for all animal activities and provide in-lab guidance regarding animal care and use at Duke.
In addition to assisting with protocol development and processing, the RACC will be trained to provide
internal compliance assistance and hands-on procedure skills to laboratory members. The Duke Animal
Program views the RACC as the laboratory ‘subject matter expert,’ who will facilitate successful use of
animals in research activities while also knowing how to accomplish the variety of regulatory tasks at
Duke. This program provides direct applicability to the researcher (smoother research application
approval, accelerated approval, decreased risk of non-compliance issues) while also benefiting the RACC
candidate (enhancing the value to the research team, improving research skills, providing an improved
knowledge of how to ‘get things done’ for animal care or use issues). RACC training is consistent with
required training for certification with AALAS (American Association for Laboratory Animal Science), and
if desired by the candidate may be used as training leading to formal certification with AALAS as an ALAT
(Assistant Laboratory Animal Technician), LAT (Laboratory Animal Technician), or LATG (Laboratory
Animal Technologist).
The RACC program is voluntary, and offered at no-cost by the Duke Animal Care and Use Program.
Managed by the Office of Animal Welfare Assurance (OAWA) with significant contributions from the
Division of Laboratory Animal Resources (DLAR) and the Institutional Animal Care and Use Committee
(IACUC), the RACC program uses a multi-modal educational approach (e.g., lectures, web-modules,
meetings, one-on-one discussion, and hands-on learning). The Research Animal Coordinator will
develop new knowledge and research skills in all aspects of animal program oversight and management
to include protocol development, compliance oversight, common animal procedures involving
anesthesia and analgesia, aseptic surgical technique, DLAR husbandry procedures, facility security,
literature searches for alternatives to painful or distressful procedures, and much more. The RACC
candidate will be evaluated throughout the RACC program and those meeting or exceeding the
minimum knowledge and skill requirements will be certified as a Duke Animal Care and Use Program
RACC. As a certified RACC, individuals shall have a greater overall knowledge of animal research, and a
clear understanding of how to efficiently conduct fully compliant research at Duke. The RACC program
will include:
• SKILLS DEVELOPMENT FOR PROTOCOL APPLICATIONS AND AMENDMENTS: The RACC will
receive tips and suggestions for writing an animal use application which is complete and will
pass muster of IACUC review. An application which meets the regulatory requirements is
generally approved more rapidly than an application with significant issues requiring
attention.
• TIPS FOR PROCESSING OF PROTOCOL APPLICATIONS & AMEMDMENTS: The RACC will
receive training in specific processing measures and tips to make the application process
most efficient. The RACC will be able to facilitate the principal investigator through the
application processes.
• PROTOCOL AND GRANT CONCORDANCE GUIDANCE: The RACC will be trained in the
process of grant concordance reviews. Having this skill set will encourage an earlier
assessment and, if necessary, proper amendment submission to make the protocol and
grant concordant, and therefore a more rapid receipt of concordance letters for the
researcher.
• POLICIES AND GUIDELINES: The RACC will receive training in Duke animal program polices,
the process of policy development, interpretation and application of the Duke policies, and
the differences between policies and guidelines. The RACC will become well versed in
Duke’s policies and learn strategies to apply those policies to benefit animal welfare and
maintain compliance.
• LABORATORY PERSONNEL TRAINING: The RACC will receive advice and direction on
effective monitoring of laboratory personnel training status and recommendation to ensure
that all members are up-to-date and compliant.
• LABORATORY RESOURCE: The RACC will be seen as the ‘in-lab’ go-to person for questions
on animal welfare, regulations, protocol compliance and animal procedures.
• TRAINER FOR BASIC ANIMAL PROCEDURES: The RACC will receive wet-lab training and be
able to instruct laboratory personnel on appropriate animal handling and basic animal
procedures.
• LABORATORY LIAISON: The RACC will have the skills to serve as a liaison and facilitator for
communication between the laboratory and the IACUC, OAWA and DLAR.
• LABORATORY MENTOR: The RACC will have the skills to educate other laboratory personnel
on proper techniques and procedures such as aseptic surgical technique, monitoring
animals for well-being, and required record keeping.
• ANIMAL CARE AND USE COMPLIANCE: The RACC will have the knowledge to effectively
guide laboratory personnel in reporting animal concerns, protocol noncompliance, and
devising self-corrective measures which have a high likelihood of being IACUC approved.
• LABORATORY OMBUDSMAN: The RACC can serve as a central laboratory member who will
disseminate updates in protocol information, new or modified policy updates.
The RACC program consist small ‘CLASSES’ of participants, generally 6-8 candidates in a specific class.
The successful candidate will complete both ‘PHASES’ of the RACC program.
PHASE I will consist of an introductory session which describes the expectations and sets a time frame
for accomplishment of the required modules. PHASE I is core material required of all candidates. Core
material training is approximately 80% web module training which can be accomplished at the
convenience of the candidate, but within the range of dates for the specific class. The remaining
sessions are small group seminars presented by Duke Animal Care and Use Program leadership.
PHASE II will consist of species specific training. The discussions and activities of PHASE II will focus on
the specie(s) in use in the RACC candidate’s laboratory. The Curriculum Matrix provides more detailed
information about PHASE 1 and PHASE II.
Duke University
Durham, North Carolina 27705
Office of Animal Welfare Assurance Voice: 919.668.6720
Campus Mail: Hock Plaza Box 2724 Fax: 919.668.6725
US Mail: 2424 Erwin Road; Suite 606; Durham, NC 27705 http://vetmed.duhs.duke.edu
The Duke University Animal Care & Use Program is committed to advancing healthcare for humans and animals
through compassionate care and progressive animal use.
RESEARCH ANIMAL COORDINATOR CERTIFICATION
Table of Contents
RAC CURRICULUM OVERVIEW
TEACHING PLANS
Week 1 Orientation
Week 2 The Duke IACUC
Week 3 Application Development
Literature Search for Alternatives to Painful or Distressful Procedures
Week 4 Document Processing
Week 5 Inspections and Audits
Week 6 Reports
Week 7 Employee Occupational Health & Wellness
Week 8 Occupational Environmental Safety Office
Week 9 Controlled Substances
Week 10 DLAR Policies
AALAS LEARNING LIBRARY ASSIGNMENTS
RACC PHASE II - SPECIES CURRICULUM
Amphibians
Birds
Cats
Dogs
Fish
Gerbils
Guinea Pigs
Mice
Nonhuman primates
Rats
Swine
Rabbits
RACC PROCEDURES TRAINING FORM
RACC APPLICATION
PRE-COURSE SURVEY
RACC CERTIFICATE OF COMPLETION
RESEARCH ANIMAL COORDINATOR CERTIFICATION (RACC) CURRICULUM
SESSION TOPIC SUB-TOPICS FORMAT INSTRUCTOR AALAS LEARNING LIBRARY MODULES
A
ORIENTATION Curriculum Review Seminar RACC Facilitator
Introduction to the RACC
B
THE DUKE IACUC IACUC Membership Seminar IACUC Chairperson Working with the IACUC – Non VA version
Subcommittees OAWA Director Animal Welfare Act Regulations
Regulations PHS Policy on Humane Care & Use
Mock Protocol Review Practical
C
APPLICATION DEVELOPMENT Protocol Development Seminar Senior Compliance Liaison Euthanasia of Research Animals
Animal number justification
Pain Recognition and Alleviation in Laboratory Animals
Policies and Exemptions
Ethical Decision Making in Animal Research
"Does this activity require
an exemption?"
Practical
LITERATURE REVIEW FOR ALTERNATIVES TO
PAINFUL OR DISTRESSFUL PROCEDURES
Components of a literature
search
Biomedical Research Librarian
3 R's
Search strategies/databases
Seminar
Literature search
assignment
Practical
D
DOCUMENT PROCESSING
OAWA Processing
Seminar Grants and Contracts Specialists
IACUC Review and
Dispostion
E INSPECTIONS AND AUDITS
IACUC Semi-annual
Inspections
Seminar Compliance Liaison Staff The Semiannual Facility Inspection
Compliance Audits
Common Compliance Issues
Case-based scenarios to
illustrate compliance or non-
compliance
Practical Maintaining Animal Procedure Areas
Post Approval Monitoring
F
REPORTS (USDA, OLAW, AAALAC)
Institutional reporting
Seminar IACUC Administrator
Annual progress reports
OAWA Associate Director
Counting animals
Scenario discussion of USDA
pain and distress categories
and quiz
Practical
G
EMPLOYEE OCCUPATIONAL HEALTH & WELLNESS
(EOHW)
Employee Health Resources
Seminar Occ. Health Physician/Nurse
Occupational Health and Safety in the Care and Use of Animals
Recognition of risk
assessment
Laboratory Animal Allergy
Required training and
medical surveillance
H
OCCUPATIONAL ENVIRONMENTAL SAFETY OFFICE
(OESO)
OESO processes and
protocol review
Seminar
Occupational Environmental Safety
Office
Syringes and Needles
SOP writing
Orientation to Bio-Safety in Microbiological and Biomedical
Laboratories
Requirements for the use of
hazardous agents
Blood-borne Pathogens Training for Animal Research
Locate SOPs using OESO
websites; chemical look-up;
reporting compliance
Practical
Laboratory Bio-Security
I
CONTROLLED SUBSTANCES Review of schedules Seminar IACUC Vice-chairperson Working with Controlled Substances
C.S. storage and
recordkeeping
Process for DEA registration
and licensure
OAWA Director
J
DLAR POLICIES AND PROCEDURES DLAR resources Seminar
DLAR Veterinarian/Assistant
Director of Facility Operations
Personal Protective Equipment for Working in a Laboratory
Animal Facility
Biosecurity
RESEARCH ANIMAL COORDINATOR CERTIFICATION TEACHING PLAN Week 1 - ORIENTATION
RESEARCH ANIMAL COORDINATOR CERTIFICATION
TEACHING PLAN
SESSION TITLE: ORIENTATION
OBJECTIVES OF THIS SESSION:
1. To provide the new RAC candidate with an overview of the course and the expectations of each
candidate.
2.
To introduce the three ‘legs’ of the animal program.
3.
To remind candidates of the obligatory nature of animal protections in animal based research.
4.
To encourage RAC candidate to explore the opportunities before them in animal care & use.
MATERIALS/RESOURCES NEEDED FOR THIS SESSION:
• Course syllabus
• Course Schedule
• Password & training for AALAS Learning Library
• Initial Survey
OBJECTIVE OF THIS SESSION: Student will recognize the significance of their training and the value that
they can contribute to their laboratory with this certification. Students will receive the necessary
guidance to begin their self-training using the AALAS LL. Students will be able to describe why they
desire RAC certification and how the certification may assist their laboratory.
ANTICIPATORY KNOWLEDGE FOR THIS SESSION:
1. A general knowledge of animal care & use at Duke.
2.
Recognition of role of the IACUC in animal care & use.
3.
Recognition of the value of animals in research, testing, teaching, or exhibition.
4.
Recognition of their laboratories activities.
STUDENT PREPARATION PRIOR TO THE SESSION: None.
METHODOLOGY TO ASSESS UNDERSTANDING:
1. Questions during the presentation
2. Scenarios discussed during the presentation
OPENING STATEMENT: The Research Animal Coordinator can serve a pivotal role within the laboratory
by assuring animal well-being and quality research outcomes and improving the efficiency of proposals
and approvals, while also discouraging the development of adverse events which could be reportable to
federal oversight agencies.
RESEARCH ANIMAL COORDINATOR CERTIFICATION TEACHING PLAN Week 1 - ORIENTATION
POINTS TO ADDRESS DURING THIS SESSION:
Candidate introductions and description of why they want to become a RAC.
Certification will not be tied to protocol approval or renewal.
This is a one-time certification, but will have annual ‘refreshers’ and quarterly interactions.
Designed to improve communications between PI, OAWA, DLAR, IACUC.
Reduce incidence of protocol non-compliance within the laboratory.
Improve flow of work between lab and support entities.
Better prepare lab staff for their roles – support of PIs projects.
Course open to all lab staff (preferred candidates are those with lab management
responsibilities).
Focus of course will be on processes, procedures which will make the researcher successful.
Consist of didactic, hands-on training, AALAS Learning Library, and Facility tours.
Hands on workshop: DLAR training and vet staff.
CLOSING STATEMENT/CONCLUSION OF TRAINING: This course is exactly what you invest into it. You
can significantly enhance your laboratories research opportunities while inoculating them from
potentially important adverse outcomes.
POST-SESSION ASSIGNMENTS:
1. Completion of AALAS LL assignments prior to the next RAC meeting.
2. Development of a single idea to improve your laboratory’s function.
RESEARCH ANIMAL COORDINATOR CERTIFICATION Week 2 – THE DUKE IACUC
DUKE UNIVERSTIY
RESEARCH ANIMAL COORDINATOR CERTIFICATION
TEACHING PLAN
SESSION TITLE: The Duke IACUC
MATERIALS/RESOURCES NEEDED FOR THIS SESSION: Students are provided an IACUC
proposal for review. The proposal has several problems that students should identify and be prepared to
discuss.
OBJECTIVES OF THIS SESSION: Be able to answer the following questions:
1. Why are IACUCs necessary?
2. What is the make‐up of the IACUC at this institution?
3. What are the responsibilities of IACUC members?
4. How does the Committee function during meetings (deliberations, dispositions)?
5. By what principles do IACUCs evaluate proposals for animal use?
ANTICIPATORY KNOWLEDGE FOR THIS SESSION: Completion of the following AALAS
LL Web Modules:
•
Working with the IACUC – Non VA version
•
Animal Welfare Act Regulations
•
PHS Policy on Humane Care & Use
STUDENT PREPARATION PRIOR TO THE SESSION:
1. Complete AALAS Learning Library modules.
2. Read, edit, and be prepared to discuss the sample IACUC protocol in a mock protocol review
session.
METHODOLOGY TO ASSESS UNDERSTANDING:
1. Did the student successfully complete the AALAS Web Modules?
2. Did the student participate in the discussion and correctly identify the protocol concerns?
3. Did the student express a familiarity with the regulations / policies that apply to the
protocol?
4. Did the student ask questions regarding aspects of the protocol that were in the ‘gray’ area?
POINTS TO ADDRESS DURING THIS SESSION:
•
Regulatory basis for IACUC requirements
•
Animal rights vs. animal welfare, including intrinsic value for mankind vs. ethical costs for
animals, 3Rs (reduce, replace, refine).
•
Composition of local IACUC
•
Responsibilities of IACUC: protocol approval, annual protocol reviews, semi‐annual facility
site visits, semi‐annual program evaluations, monitor protocol compliance, investigate
animal welfare concerns
•
Structure of local IACUC meeting (particularly important if IACUC meetings are “closed”)
•
Principles to consider in protocol review, including examples
•
Discussion of sample protocol
POST
‐
SESSION ASSIGNMENT: None
RESEARCH ANIMAL COORDINATOR CERTIFICATION Week 3 – APPLICATION DEVELOPMENT
DUKE UNIVERSTIY
RESEARCH ANIMAL COORDINATOR CERTIFICATION
TEACHING PLAN
SESSION TITLE: Application Development
TRAINING OBJECTIVES OF THIS SESSION:
1. Introduce the RAC candidates to the regulatory bodies and documents that guide the IACUC
Animal Use Application review process.
2. Introduce the 3 R’s: Replacement, Reduction and Refinement
3. Orient the RAC candidate to the structure and format of the Animal Use Application
4. Discuss common pitfalls of the application process (personnel, animal number justification,
research facilities, special husbandry requirements, controlled substance use for research,
withholding anesthesia or analgesia, euthanasia and exemptions).
MATERIALS/RESOURCES NEEDED FOR THIS SESSION:
• Dr. Hale’s mock protocol – PI: Smythe, “Mechanisms of Inflammatory Bowel Disease
Pathogenesis”
• Dr. Vanderford’s OAWA review for mock protocol
• Power Point handout for note taking
STUDENT OBJECTIVE OF THIS SESSION:
At the conclusion of this session, the student will gain insight into the OAWA and IACUC review process.
They will become more familiar with the application process and the regulatory reasons for the
requested information. The RAC graduates will be well-prepared to take on the responsibility of protocol
and amendment application for their laboratories.
ANTICIPATORY KNOWLEDGE FOR THIS SESSION:
Students will have varied backgrounds in laboratories, but will all be familiar with the Animal Use
Application and IACUC review process.
STUDENT PREPARATION PRIOR TO THE SESSION:
Students will have gone over Dr. Hale’s mock protocol in a previous class.
METHODOLOGY TO ASSESS UNDERSTANDING:
Students are provided with the OAWA review of Dr. Hale’s mock protocol from the previous session. At
the conclusion of my presentation, we will apply the concepts by going over the review and eliciting
questions from their own laboratory experiences (i.e. different species, different types of procedures,
RESEARCH ANIMAL COORDINATOR CERTIFICATION Week 3 – APPLICATION DEVELOPMENT
etc.). Hopefully they will get a broader understanding of how to apply the regulatory review concepts in
various contexts.
OPENING STATEMENT:
What happens to your protocol after you submit it to IACUC@duke.edu
?
POINTS TO ADDRESS DURING THIS SESSION:
Animal Use Application processing and review process
Regulatory guidance and resources
Goals of OAWA and IACUC protocol review
The 3 R’s
Introduction to the Animal Use Application
Common pitfalls of the application process
Expectations for recognition and treatment of painful or distressful procedures
The requirements for scientific justification for withholding anesthesia or analgesia
Euthanasia policies at Duke
The requirements for scientific justification for exemptions
Process for requesting a pre-review of a draft application
Contact information for assistance with protocol application development
INTERACTIVE EXERCISE OR ASSIGNMENT:
I will lead a scenario based game entitled “Does this activity require an exemption?”
CLOSING STATEMENT:
Encourage RAC students to be the representatives for their laboratories and consider taking on the role
of protocol and amendment processing for their PI’s.
POST-SESSION ASSIGNMENT:
Encourage students to call with questions as they arise.
RESEARCH ANIMAL COORDINATOR CERTIFICATION Week 3 – LITERATURE SEARCH
DUKE UNIVERSTIY
RESEARCH ANIMAL COORDINATOR CERTIFICATION
TEACHING PLAN
SESSION TITLE: Searching the Literature for Animal Alternatives to Painful Procedures
OBJECTIVES OF THIS SESSION:
Learners will be able to:
• Focus a research protocol question into the components needed to conduct a thorough
literature search
• Select appropriate databases to search
• Design search strategies to cover the 3 R’s
• Understand and apply basic search tools like Boolean operators, truncation, and subject
headings appropriately
• Conduct a search in PubMed
MATERIALS/RESOURCES NEEDED FOR THIS SESSION:
• Projector
• Computer with access to the internet
ANTICIPATORY KNOWLEDGE FOR THIS SESSION: It would be useful for students to have some prior
knowledge of basic literature search skills. Students should also have knowledge of the 3 R’s and why it
is important to do a search for animal alternatives to painful procedures. It would be more relevant for
the student if they came to the session with an example protocol in mind from work they have done or
plan to do.
STUDENT PREPARATION PRIOR TO THE SESSION:
Students should review the online guide: http://guides.mclibrary.duke.edu/animalalternatives
METHODOLOGY TO ASSESS UNDERSTANDING:
A brief assignment given after the session requiring them to complete an animal alternatives literature
search and fill out a series of questions describing the process. I will review their answers and provide
feedback.
OPENING STATEMENT:
• Introduce myself
RESEARCH ANIMAL COORDINATOR CERTIFICATION Week 3 – LITERATURE SEARCH
• Introduce Library Guide: http://guides.mclibrary.duke.edu/animalalternatives
• Discuss the need for searching and the 3 R’s
POINTS TO ADDRESS DURING THIS SESSION:
Developing a Search strategy
o Focus your question
o Strategies for each of the 3 R’s
o Searching basics (Boolean operators, truncation, etc.)
o Search PubMed
How to use MeSH terms
Demonstrate a search in PubMed
Review NCBI Account Features
CLOSING STATEMENT
Contact the Library for help with searching the literature and use the materials we have provided in
class and online as guides.
INTERACTIVE EXERCISE OR ASSIGNMENT:
During the session I will work through an example and will engage students in helping to make decisions
and complete a search. After the session they will have a brief assignment to conduct a literature search
and answer questions about the search.
RESEARCH ANIMAL COORDINATOR CERTIFICATION Week 4 – DOCUMENT PROCESSING
DUKE UNIVERSTIY
RESEARCH ANIMAL COORDINATOR CERTIFICATION
TEACHING PLAN
SESSION TITLE: Document Processing
OBJECTIVES OF THIS SESSION:
1. To familiarize the RACC students with the forms to submit for protocols and amendments, and
the deadlines to do so.
2. To discuss the protocol specialist role in processing amendments, protocols and renewals.
3. To exemplify common mistakes when filling out and submitting the forms.
MATERIALS/RESOURCES NEEDED FOR THIS SESSION:
-Print outs of common forms RACCs will submit.
OBJECTIVE OF THIS SESSION:
Students should have a better understanding of the protocol, renewal and amendment submission
process. They should be able to recognize common mistakes when filling out these forms, so as to
insure they will not make these mistakes in the future.
ANTICIPATORY KNOWLEDGE FOR THIS SESSION:
• Appreciation of the importance of protperly filling out and submitting protocol and amendment
forms.
• Familiarization with commonly submitted forms.
• Resources to assist RACCs in their submissions.
STUDENT PREPARATION PRIOR TO THE SESSION:
None
METHODOLOGY TO ASSESS UNDERSTANDING:
• Questions during the presentation
• Active discussion during presentation
• Role play with students reviewing form as if they were processing it.
OPENING STATEMENT:
Submitting forms correctly is extremely important, because without protocols PIs cannot conduct
research. The speed in which protocols and amendments can be approved is much faster if originally
submitted correctly.
RESEARCH ANIMAL COORDINATOR CERTIFICATION Week 4 – DOCUMENT PROCESSING
POINTS TO ADDRESS DURING THIS SESSION:
Commonly used forms and where they are located.
The importance in checking for the newest version.
Deadlines
Common mistakes
Granite numbers
Importance in responding to questions regarding submissions.
CLOSING STATEMENT:
Protocol and amendment approval is extremely important and are much more efficiently processed
when submitted correctly initially. Learn who the protocol specialist is for your department and they
can assist you in future submissions.
POST-SESSION ASSIGNMENT:
None
RESEARCH ANIMAL COORDINATOR CERTIFICATION Week 5 – POST APPROVAL MONITORING
DUKE UNIVERSTIY
RESEARCH ANIMAL COORDINATOR CERTIFICATION
TEACHING PLAN
SESSION TITLE: Post Approval Monitoring
OBJECTIVES OF THIS SESSION:
1. To provide an overview of the post approval monitoring program
2. To identify and discuss most common non-compliances
3. To discuss reporting of adverse events
MATERIALS/RESOURCES NEEDED FOR THIS SESSION:
None
OBJECTIVE OF THIS SESSION:
Student should be able to understand how the post approval monitoring program works and its
importance at Duke. They should also understand what the common categories of non-compliance are
and how to avoid these, as well as how to report adverse or unanticipated events to the IACUC.
ANTICIPATORY KNOWLEDGE FOR THIS SESSION:
• Recognition of the role of the IACUC in animal care and use
• Recognition of the value of animals in research, testing and teaching
• Recognition of their laboratory’s activities
STUDENT PREPARATION PRIOR TO THE SESSION:
None
METHODOLOGY TO ASSESS UNDERSTANDING:
• Questions during the presentation
• Active discussion during presentation
OPENING STATEMENT:
Post Approval Monitoring is an important part of the Duke research community and serves as a way to
validate training, knowledge of the animal care and use policies and individual protocols. It is a team
effort among the OAWA, IACUC, DLAR and research personnel. Everyone is responsible for assuring the
humane care and use of the animals at Duke.
POINTS TO ADDRESS DURING THIS SESSION:
Description of Post Approval Monitoring Program at Duke
RESEARCH ANIMAL COORDINATOR CERTIFICATION Week 5 – POST APPROVAL MONITORING
Importance of Post Approval Monitoring
Importance of Post Approval Monitoring being a team effort
Common categories of non-compliance for previous year
How to identify non-compliances
How to avoid non-compliances
How to report non-compliances and adverse or unanticipated events
CLOSING STATEMENT:
Post Approval Monitoring is an important part of the Duke animal care and use community. It takes a
team effort to ensure the highest quality program. Research personnel are vital to this program as they
are daily participants in animal care and use and serve as eyes and ears in the field.
INTERACTIVE EXERCISE OR ASSIGNMENT:
We will list some scenarios and ask students to tell us whether procedures are non-compliant or
compliant.
RESEARCH ANIMAL COORDINATOR CERTIFICATION Week 6 – REPORTS
DUKE UNIVERSTIY
RESEARCH ANIMAL COORDINATOR CERTIFICATION
TEACHING PLAN
SESSION TITLE: Annual Reporting
OBJECTIVES OF THIS SESSION: Be able to: 1)Describe the details of what the institution is required to
report to PHS, USDA, and AAALAC, Int. each year; 2) Understand how to count “animals used” for USDA,
AALAC, and protocol-specific annual reports; and 3) Provide accurate annual reports related to the
participant’s own research protocols .
MATERIALS/RESOURCES NEEDED FOR THIS SESSION: None
ANTICIPATORY KNOWLEDGE FOR THIS SESSION: Basic understanding of regulatory entities: PHS, USDA,
and AAALAC, Int. and Duke’s requirement for submission of a protocol annual report for all protocols.
STUDENT PREPARATION PRIOR TO THE SESSION: The AALAS Learning Library modules covering PHS
Policy and Animal Welfare Act/Regulations have previously been covered with the regulations
component of “The Duke IACUC” seminar.
METHODOLOGY TO ASSESS UNDERSTANDING: Evaluation of the completeness and accuracy of future
reports submitted as data for preparation of institutional annual reports and for annual protocol
renewals.
OPENING STATEMENT: Not applicable
POINTS TO ADDRESS DURING THIS SESSION:
Differences in definition of an animal between USDA, OLAW, AAALAC, and your institution
What information is required from each lab group with regard to preparation of the USDA
annual report, including categorization of animals in pain categories B – E
What information is required for preparation of annual reports to OLAW
What information is required for preparation of annual reports to AAALAC
What information is required in annual reports specific to each protocol (“annual renewals”)
and how that may differ from what is provided for the other institution-wide reports
CLOSING STATEMENT: Not applicable
INTERACTIVEEXERCISE OR ASSIGMNENT:
In class scenario discussion of USDA pain and distress categories
In class group quiz on animal counting, deadlines, USDA pain and distress categories,
exemptions, and Category E scientific justification
RESEARCH ANIMAL COORDINATOR CERTIFICATION Week 7 – EOHW
DUKE UNIVERSTIY
RESEARCH ANIMAL COORDINATOR CERTIFICATION
TEACHING PLAN
SESSION TITLE: Employee Occupational Health and Wellness: Ensuring Health and Safety of Employees
Working with Research Animals
OBJECTIVES OF THIS SESSION:
1. Know the component resources comprising EOHW: Personal Assistance Service (PAS), Live for
Life (LFL) and Employee Occupational Health (EOH)
2. Recognize circumstances EOH utilization is indicated: work-related injury/illness, preparation for
work-related international travel, fitness for duty evaluations, reproductive health consultation
3. Understand reason employees are required to complete employee health medical surveillance
for animal handlers – prevention of lab animal allergies, protection of animals
MATERIALS/RESOURCES NEEDED FOR THIS SESSION: EOHW and OESO websites
OBJECTIVE OF THIS SESSION: Access EOHW appropriately and ensure employees comply with
surveillance requirements
ANTICIPATORY KNOWLEDGE FOR THIS SESSION: Work at Duke in a research lab
STUDENT PREPARATION PRIOR TO THE SESSION: Be familiar with OESO and EOHW websites
METHODOLOGY TO ASSESS UNDERSTANDING: Answer questions at end of session
OPENING STATEMENT: EOHW Mission – enhance health and productivity of the workforce, diminish risk
to individual employee, and institution, address regulatory expectations.
POINTS TO ADDRESS DURING THIS SESSION:
1. PAS overview
2. LFL overview
3. EOHW services including Fitness for Duty assessments, Travel Health Services, Reproductive
Health Counsel, Work-related injury/illness care and medical surveillance
4. Goals of Medical Surveillance
5. Lab animal allergies etiology and preventive methods
6. Process of Duke Animal Handler medical surveillance
7. General overview of medical surveillance for respirator use, latex exposure, high containment
laboratory work
CLOSING STATEMENT: Students should now have an improved knowledge of EOHW resources
available, basis for medical surveillance requirements including animal handler surveillance and how to
access EOHW.
POST-SESSION ASSIGNMENT: None
RESEARCH ANIMAL COORDINATOR CERTIFICATION Week 8 – OESO
DUKE UNIVERSTIY
RESEARCH ANIMAL COORDINATOR CERTIFICATION
TEACHING PLAN
SESSION TITLE: Research Animal Coordinator Certification (RACC) Training – Occupational & Environmental Safety
Office
OBJECTIVES OF THIS SESSION:
1. To become familiar with OESO and the responsibilities of each division and their resources
2. To understand the protocol review process through OESO
3. To review use of the OESO Laboratory Management System
4. To review writing SOPs and further explain OESO and IACUC requirements for use of hazardous agents in animals
MATERIALS/RESOURCES NEEDED FOR THIS SESSION: Copies of slides, sample protocol review form, homework
questions
OBJECTIVE OF THIS SESSION: The objective is to have students be able to assist in preparing protocols for submission
with all the required information included (e.g., SOPs, updated personnel in the online management system) to enable
quick, efficient clearance of their protocol.
ANTICIPATORY KNOWLEDGE FOR THIS SESSION: Knowledge of their laboratory’s biological, chemical, and/or
radiological hazards relevant to animal research
STUDENT PREPARATION PRIOR TO THE SESSION: Read slides, familiarize self with OESO website, attempt to answer
the homework questions
METHODOLOGY TO ASSESS UNDERSTANDING: Completion and review of homework assignment
OPENING STATEMENT: OESO wants to partner with labs to create a safer work environment. Through this class you
will learn to use the OESO website and many resources available to lab employees. You will be prepared to submit
your protocol with all required information and understand why these requirements are in place in order to achieve
OESO clearance.
POINTS TO ADDRESS DURING THIS SESSION:
Prevention of Occupational Exposure to Biological, Chemical and Radiological agents
Prevention of injuries from safety and ergonomic hazards
What OESO screens for in the protocol review
Section H
Training compliance
Hazardous Agent and Animal Handling SOPs
OESO clearance
CLOSING STATEMENT: We hope that you have learned about the many resources available through OESO and we
look forward to working with you to make your lab a safer work environment. (Contact information for OESO staff
involved in the protocol review process is made available.)
INTERACTIVE EXERCISE OR ASSIGNMENT: The class will participate in the following: Locate SOPs using various OESO
websites; conduct chemical look up; reporting and training compliance within the Laboratory Safety Management
database; complete homework assignment and review.
RESEARCH ANIMAL COORDINATOR CERTIFICATION Week 9 – CONTROLLED DRUGS
DUKE UNIVERSITY
RESEARCH ANIMAL COORDINATOR CERTIFICATION
TEACHING PLAN
SESSION TITLE: Controlled Substances Management in Animal Research at Duke
OBJECTIVES OF THIS SESSION: At the completion of this module, students should understand 1) the
regulatory oversight for the use of controlled agents for animal research at Duke, 2) controlled drug
schedules, 3) the application process for federal and state registrations, 4) security and storage of
controlled agents, 5) record-keeping and documentation for controlled drugs, 6) method of disposal, 7)
audits and 8) how to report concerns.
MATERIALS/RESOURCES NEEDED FOR THIS SESSION: None
ANTICIPATORY KNOWLEDGE FOR THIS SESSION: Basic understanding of regulatory oversight for
controlled drugs: DEA (Drug Enforcement Administration) and DHHS (Department of Health and Human
Services).
STUDENT PREPARATION PRIOR TO THE SESSION: AALAS Learning Library module “Working with
Controlled Substances.”
METHODOLOGY TO ASSESS UNDERSTANDING: Group discussion on key points presented
OPENING STATEMENT: Seminar will follow Power Point presentation
POINTS TO ADDRESS DURING THIS SESSION:
Regulatory oversight for controlled drug use for animal research
Controlled substance schedules and commonly used drugs for animal research
Definitions related to licensure and oversight of controlled drugs
Application process for DEA and DHHS registration
Security and storage for controlled drugs
Recordkeeping
Methods of disposal
Controlled drug auditing
Reporting concerns related to diversion
Helpful resources
CLOSING STATEMENT: Not applicable
INTERACTIVE EXERCISE OR ASSIGNMENT: Question and answer session
RESEARCH ANIMAL COORDINATOR CERTIFICATION Week 10 – DLAR
DUKE UNIVERSTIY
RESEARCH ANIMAL COORDINATOR CERTIFICATION
TEACHING PLAN
SESSION TITLE: DLAR Husbandry and Operations
OBJECTIVES OF THIS SESSION:
Provide information for research staff on what DLAR’s mission is, what
our staff brings to the research equation, what DLAR resources are available, and provide contact
information to make it easier to access DLAR services.
MATERIALS/RESOURCES NEEDED FOR THIS SESSION: None
OBJECTIVE OF THIS SESSION: To provide useful information about DLAR operations and husbandry
procedures and to encourage dialog between DLAR and research staff.
ANTICIPATORY KNOWLEDGE FOR THIS SESSION: N/A
STUDENT PREPARATION PRIOR TO THE SESSION: N/A
METHODOLOGY TO ASSESS UNDERSTANDING: Open dialog
OPENING STATEMENT: We are Happy to have the opportunity to find out what DLAR can do to provide
you with excellent customer service and easy access to DLAR resources.
POINTS TO ADDRESS DURING THIS SESSION:
Services we provide
How to contact the right DLAR personnel for what you need
How can we help?
CLOSING STATEMENT: We want to emphasize that our goal is to be a valued member of your research
team and to provide the best possible animal care and customer service.
POST-SESSION ASSIGNMENT: None
DUKE UNIVERSITY ANIMAL CARE AND USE PROGRAM
RESEARCH ANIMAL COORDINATOR CERTIFICATION PROGRAM
AALAS LEARNING LIBRARY ASSIGNMENTS FOR COURSE COMPLETION
Please Note**: These modules should be completed prior to the date class meets.
SUBJECT: The Duke IACUC
Working with the IACUC – Non VA version
Animal Welfare Act Regulations
PHS Policy on Humane Care & Use
SUBJECT: Application Development
Euthanasia of Research Animals – AVMA Guidelines
Pain Recognition and Alleviation in Laboratory Animals
Ethical Decision Making in Animal Research
SUBJECT: Inspections/Audits
The Semiannual Facility Inspection
Ethical Decision Making in Animal Research
Common Compliance Issues
Maintaining Animal Procedure Areas
Post Approval Monitoring
SUBJECT: Employee Occupational Health and Welfare (EOHW
Occupational Health & Safety in the Care and Use of Animals
Laboratory Animal Allergy
SUBJECT: Occupational Environmental Safety Office (OESO)
Syringes and Needles
Orientation to Bio-Safety in Microbiological and Biomedical Laboratories
Bloodborne Pathogens Training for Animal Research
Laboratory Bio-Security
SUBJECT: Controlled Substances
Working with Controlled Substances
SUBJECT: DLAR Animal Care Policies and Procedures
Personal Protective Equipment for Working in a Laboratory Animal Facility
Topic Sub-topics Format Details Time Notes Exceptions
Species
Specific
Training
Web
Module
A.L.L. Module + Quiz
for ALAT Training
"ALAT 30: Amphibians"
120
If working with a
species where there is
NOT a A.L.L. module
for, one-on-one
training may be
required
Handling and Restraint
Injections
Blood withdrawals
Identification
Oral gavage
Web
Module
A.L.L. Module + Quiz
"Pain recognition and
alleviation in
laboratory animals"
90
Recommend this prior to lecture to address
any questions
Lecture
60
Cover Duke's policies; stress importance of
following anesthetic and analgesic plan
outlined in the approved protocol
Web
Module
A.L.L. Module + Quiz
"Aseptic Technique for
Rodent Survival
Surgery"
120
Recommend this prior to lecture to address
any questions
Web
Video
12
http://oacu.od.nih.gov/UsefulResources/AT
TC.wmv
Lecture
30
Cover Duke's policies and STRESS different
requirments of mouse/rat aseptic
procedures (seen in module) and Bird
species
Peri-op
Intra-op
Post-op
Recordkeeping Lecture 30 Cover Duke's policies
Maintenance of the
facility
Review of husbandry
policies
Security
Do's and Don'ts
Protocol compliance
Ensuring death
Total Time:
702 11.7 hours
Lecture 300 5
hours
Web Based 342 5.7
hours
Other 60 1
hours
Tour to be scheduled with DLAR staff
member, preferable to coordinate with
husbandry supervisor of the area their
animals are housed
Should be required
for RACs from PI
managed areas also;
facility they tour
should have similar
species/housing that
is used in the
laboratory
Euthanasia
Lecture 30 Focus on Duke/IACUC policy and stress
secondary method
DLAR
Husbandry
Tour
60
Expectations
of care
Pain, anesthesia and
analgesia
• Pain recognition
• Anesthetics,
analgesics,
tranquilizers,
neuromuscular
blocking agents
Aseptic Surgical
Technique
Procedures
Future
Recommendation:
Cover this topic in a
hands-on wet-lab
Surgical Monitoring
Lecture
90
Cover Duke's policies and record
requirements
• Highlight: Peri-op analgesics, fasting,
evaluation of animal condition; Intra-op
monitoring for surgical depth; Post-op
monitoring requirements
Lecture covering the
basics of common
procedures
60
• Focus of this lecture should cover general
considerations for common procedures and
highlight any obvious species specific
diffrences
• Review Duke's policies and procedures
(what ones are available and where to find
them)
• Allow time for specific questions on
species or web module
• Discuss means to request individual or
protocol/species specific training
As the RACC training
program grows,
consider a hands-on
portion that is
protocol/species
specific
Research Animal Coordinator Certification (RACC) Curriculum
Section 2-D
Animal Specific Training: Amphibians
Lecture
Topic Sub-topics Format Details Time Notes Exceptions
Species
Specific
Training
Web
Module
A.L.L. Module + Quiz
for ALAT Training
"ALAT 29: Birds"
120
If working with a
species where there is
NOT an A.L.L. module,
one-on-one training
may be required
Handling and Restraint
Injections
Blood withdrawals
Identification
Oral gavage
Web
Module
A.L.L. Module + Quiz
"Pain recognition and
alleviation in
laboratory animals"
90
Recommend this prior to lecture to address
any questions
Lecture
60
Cover Duke's policies; stress importance of
following anesthetic and analgesic plan
outlined in the approved protocol
Web
Module
A.L.L. Module + Quiz
"Aseptic Technique for
Rodent Survival
Surgery"
120
Recommend this prior to lecture to address
any questions
Web
Video
12
http://oacu.od.nih.gov/UsefulResources/AT
TC.wmv
Lecture
30
Cover Duke's policies and STRESS different
requirments of mouse/rat aseptic
procedures (seen in module) and Bird
species
Peri-op
Intra-op
Post-op
Recordkeeping Lecture 30 Cover Duke's policies
Maintenance of the
facility
Review of husbandry
policies
Security
Do's and Don'ts
Protocol compliance
Ensuring death
Total Time:
702 11.7 hours
Lecture 300 5
hours
Web Based 342 5.7
hours
Other 60 1
hours
Tour to be scheduled with DLAR staff
member, preferable to coordinate with
husbandry supervisor of the area their
animals are housed
Should be required
for RACs from PI
managed areas also;
facility they tour
should have similar
species/housing that
is used in the
laboratory
Euthanasia
Lecture
30
Focus on Duke/IACUC policy and stress
secondary method
DLAR
Husbandry
Tour
60
Expectations
of care
Pain, anesthesia and
analgesia
• Pain recognition
• Anesthetics,
analgesics,
tranquilizers,
neuromuscular
blocking agents
Aseptic Surgical
Technique
Procedures
Future
Recommendation:
Cover this topic in a
hands-on wet-lab
Surgical Monitoring
Lecture
90
Cover Duke's policies and record
requirements
• Highlight: Peri-op analgesics, fasting,
evaluation of animal condition; Intra-op
monitoring for surgical depth; Post-op
monitoring requirements
Lecture covering the
basics of common
procedures
60
• Focus of this lecture should cover general
considerations for common procedures and
highlight any obvious species specific
diffrences
• Review Duke's policies and procedures
(what ones are available and where to find
them)
• Allow time for specific questions on
species or web module
• Discuss means to request individual or
protocol/species specific training
As the RACC training
program grows,
consider a hands-on
portion that is
protocol/species
specific
Research Animal Coordinator Certification (RACC) Curriculum
Section 2-D
Animal Specific Training: Birds
Lecture
Topic Sub-topics Format Details Time Notes Exceptions
Species
Specific
Training
Web
Module
A.L.L. Module + Quiz
for ALAT Training
"ALAT 24: Cats"
120
If working with a
species where there is
NOT a A.L.L. module
for, one-on-one
training may be
required
Handling and Restraint
Injections
Blood withdrawals
Identification
Oral gavage
Web
Module
A.L.L. Module + Quiz
"Pain recognition and
alleviation in
laboratory animals"
90
Recommend this prior to lecture to address
any questions
Lecture
60
Cover Duke's policies; stress importance of
following anesthetic and analgesic plan
outlined in the approved protocol
Web
Module
A.L.L. Module + Quiz
"Aseptic Technique for
Rodent Survival
Surgery"
120
Recommend this prior to lecture to address
any questions
Web
Video
12
http://oacu.od.nih.gov/UsefulResources/AT
TC.wmv
Lecture
30
Cover Duke's policies and STRESS different
requirments of mouse/rat aseptic
procedures (seen in module) and Bird
species
Peri-op
Intra-op
Post-op
Recordkeeping Lecture 30 Cover Duke's policies
Maintenance of the
facility
Review of husbandry
policies
Security
Do's and Don'ts
Protocol compliance
Ensuring death
Total Time:
702 11.7 hours
Lecture 300 5
hours
Web Based 342 5.7
hours
Other 60 1
hours
Tour to be scheduled with DLAR staff
member, preferable to coordinate with
husbandry supervisor of the area their
animals are housed
Should be required
for RACs from PI
managed areas also;
facility they tour
should have similar
species/housing that
is used in the
laboratory
Euthanasia
Lecture
30
Focus on Duke/IACUC policy and stress
secondary method
DLAR
Husbandry
Tour
60
Expectations
of care
Pain, anesthesia and
analgesia
• Pain recognition
• Anesthetics,
analgesics,
tranquilizers,
neuromuscular
blocking agents
Aseptic Surgical
Technique
Procedures
Future
Recommendation:
Cover this topic in a
hands-on wet-lab
Surgical Monitoring
Lecture
90
Cover Duke's policies and record
requirements
• Highlight: Peri-op analgesics, fasting,
evaluation of animal condition; Intra-op
monitoring for surgical depth; Post-op
monitoring requirements
Lecture covering the
basics of common
procedures
60
• Focus of this lecture should cover general
considerations for common procedures and
highlight any obvious species specific
diffrences
• Review Duke's policies and procedures
(what ones are available and where to find
them)
• Allow time for specific questions on
species or web module
• Discuss means to request individual or
protocol/species specific training
As the RACC training
program grows,
consider a hands-on
portion that is
protocol/species
specific
Research Animal Coordinator Certification (RACC) Curriculum
Section 2-D
Animal Specific Training: Cats
Lecture
Topic Sub-topics Format Details Time Notes Exceptions
Species
Specific
Training
Web
Module
A.L.L. Module + Quiz
for ALAT Training
"ALAT 25: Dogs"
120
If working with a
species where there is
NOT a A.L.L. module
for, one-on-one
training may be
required
Handling and Restraint
Injections
Blood withdrawals
Identification
Oral gavage
Web
Module
A.L.L. Module + Quiz
"Pain recognition and
alleviation in
laboratory animals"
90
Recommend this prior to lecture to address
any questions
Lecture
60
Cover Duke's policies; stress importance of
following anesthetic and analgesic plan
outlined in the approved protocol
Web
Module
A.L.L. Module + Quiz
"Aseptic Technique for
Rodent Survival
Surgery"
120
Recommend this prior to lecture to address
any questions
Web
Video
12
http://oacu.od.nih.gov/UsefulResources/AT
TC.wmv
Lecture
30
Cover Duke's policies and STRESS different
requirments of mouse/rat aseptic
procedures (seen in module) and Bird
species
Peri-op
Intra-op
Post-op
Recordkeeping Lecture 30 Cover Duke's policies
Maintenance of the
facility
Review of husbandry
policies
Security
Do's and Don'ts
Protocol compliance
Ensuring death
Total Time:
702 11.7 hours
Lecture 300 5
hours
Web Based 342 5.7
hours
Other 60 1
hours
Tour to be scheduled with DLAR staff
member, preferable to coordinate with
husbandry supervisor of the area their
animals are housed
Should be required
for RACs from PI
managed areas also;
facility they tour
should have similar
species/housing that
is used in the
laboratory
Euthanasia
Lecture
30
Focus on Duke/IACUC policy and stress
secondary method
DLAR
Husbandry
Tour
60
Expectations
of care
Pain, anesthesia and
analgesia
• Pain recognition
• Anesthetics,
analgesics,
tranquilizers,
neuromuscular
blocking agents
Aseptic Surgical
Technique
Procedures
Future
Recommendation:
Cover this topic in a
hands-on wet-lab
Surgical Monitoring
Lecture
90
Cover Duke's policies and record
requirements
• Highlight: Peri-op analgesics, fasting,
evaluation of animal condition; Intra-op
monitoring for surgical depth; Post-op
monitoring requirements
Lecture covering the
basics of common
procedures
60
• Focus of this lecture should cover general
considerations for common procedures and
highlight any obvious species specific
diffrences
• Review Duke's policies and procedures
(what ones are available and where to find
them)
• Allow time for specific questions on
species or web module
• Discuss means to request individual or
protocol/species specific training
As the RACC training
program grows,
consider a hands-on
portion that is
protocol/species
specific
Research Animal Coordinator Certification (RACC) Curriculum
Section 2-D
Animal Specific Training: Dogs
Lecture
Topic Sub-topics Format Details Time Notes Exceptions
Species
Specific
Training
Web
Module
A.L.L. Module + Quiz
for ALAT Training
"ALAT 31: Fish"
120
If working with a
species where there is
NOT a A.L.L. module
for, one-on-one
training may be
required
Handling and Restraint
Injections
Blood withdrawals
Identification
Oral gavage
Web
Module
A.L.L. Module + Quiz
"Pain recognition and
alleviation in
laboratory animals"
90
Recommend this prior to lecture to address
any questions
Lecture
60
Cover Duke's policies; stress importance of
following anesthetic and analgesic plan
outlined in the approved protocol
Web
Module
A.L.L. Module + Quiz
"Aseptic Technique for
Rodent Survival
Surgery"
120
Recommend this prior to lecture to address
any questions
Web
Video
12
http://oacu.od.nih.gov/UsefulResources/AT
TC.wmv
Lecture
30
Cover Duke's policies and STRESS different
requirments of mouse/rat aseptic
procedures (seen in module) and Bird
species
Peri-op
Intra-op
Post-op
Recordkeeping Lecture 30 Cover Duke's policies
Maintenance of the
facility
Review of husbandry
policies
Security
Do's and Don'ts
Protocol compliance
Ensuring death
Total Time:
702 11.7 hours
Lecture 300 5
hours
Web Based 342 5.7
hours
Other 60 1
hours
Tour to be scheduled with DLAR staff
member, preferable to coordinate with
husbandry supervisor of the area their
animals are housed
Should be required
for RACs from PI
managed areas also;
facility they tour
should have similar
species/housing that
is used in the
laboratory
Euthanasia
Lecture
30
Focus on Duke/IACUC policy and stress
secondary method
DLAR
Husbandry
Tour
60
Expectations
of care
Pain, anesthesia and
analgesia
• Pain recognition
• Anesthetics,
analgesics,
tranquilizers,
neuromuscular
blocking agents
Aseptic Surgical
Technique
Procedures
Future
Recommendation:
Cover this topic in a
hands-on wet-lab
Surgical Monitoring
Lecture
90
Cover Duke's policies and record
requirements
• Highlight: Peri-op analgesics, fasting,
evaluation of animal condition; Intra-op
monitoring for surgical depth; Post-op
monitoring requirements
Lecture covering the
basics of common
procedures
60
• Focus of this lecture should cover general
considerations for common procedures and
highlight any obvious species specific
diffrences
• Review Duke's policies and procedures
(what ones are available and where to find
them)
• Allow time for specific questions on
species or web module
• Discuss means to request individual or
protocol/species specific training
As the RACC training
program grows,
consider a hands-on
portion that is
protocol/species
specific
Research Animal Coordinator Certification (RACC) Curriculum
Section 2-D
Animal Specific Training: Fish
Lecture
Topic Sub-topics Format Details Time Notes Exceptions
Species
Specific
Training
Web
Module
A.L.L. Module + Quiz
for ALAT Training
"ALAT 21: Gerbils"
120
If working for a
species where there is
NOT a A.L.L. module
for, one-on-one
training may be
required
Handling and Restraint
Injections
Blood withdrawals
Identification
Oral gavage
Web
Module
A.L.L. Module + Quiz
"Pain recognition and
alleviation in
laboratory animals"
90
Recommend this prior to lecture to address
any questions
Lecture
60
Cover Duke's policies; stress importance of
following anesthetic and analgesic plan
outlined in the approved protocol
Web
Module
A.L.L. Module + Quiz
"Aseptic Technique for
Rodent Survival
Surgery"
120
Recommend this prior to lecture to address
any questions
Web
Video
12
http://oacu.od.nih.gov/UsefulResources/AT
TC.wmv
Lecture
30
Cover Duke's policies and STRESS different
requirments of mouse/rat aseptic
procedures (seen in module) and Bird
species
Peri-op
Intra-op
Post-op
Recordkeeping Lecture 30 Cover Duke's policies
Maintenance of the
facility
Review of husbandry
policies
Security
Do's and Don'ts
Protocol compliance
Ensuring death
Total Time:
702 11.7 hours
Lecture 300 5
hours
Web Based 342 5.7
hours
Other 60 1
hours
Lecture covering the
basics of common
procedures
60
• Focus of this lecture should cover general
considerations for common procedures and
highlight any obvious species specific
diffrences
• Review Duke's policies and procedures
(what ones are available and where to find
them)
• Allow time for specific questions on
species or web module
• Discuss means to request individual or
protocol/species specific training
As the RACC training
program grows,
consider a hands-on
portion that is
protocol/species
specific
Research Animal Coordinator Certification (RACC) Curriculum
Section 2-D
Animal Specific Training: Gerbils
Lecture
Future
Recommendation:
Cover this topic in a
hands-on wet-lab
Surgical Monitoring
Lecture 90
Cover Duke's policies and record
requirements
• Highlight: Peri-op analgesics, fasting,
evaluation of animal condition; Intra-op
monitoring for surgical depth; Post-op
monitoring requirements
Expectations
of care
Pain, anesthesia and
analgesia
• Pain recognition
• Anesthetics,
analgesics,
tranquilizers,
neuromuscular
blocking agents
Aseptic Surgical
Technique
Procedures
Tour to be scheduled with DLAR staff
member, preferable to coordinate with
husbandry supervisor of the area their
animals are housed
Should be required
for RACs from PI
managed areas also;
facility they tour
should have similar
species/housing that
is used in the
laboratory
Euthanasia
Lecture
30
Focus on Duke/IACUC policy and stress
secondary method
DLAR
Husbandry
Tour
60
Topic Sub-topics Format Details Time Notes Exceptions
Species
Specific
Training
Web
Module
A.L.L. Module +
Quiz for ALAT
Training "ALAT 22:
Guinea Pigs"
120
If working for a
species where there is
NOT a A.L.L. module
for, one-on-one
training may be
required
Handling and Restraint
Injections
Blood withdrawals
Identification
Oral gavage
Web
Module
A.L.L. Module +
Quiz "Pain
recognition and
alleviation in
laboratory animals"
90
Recommend this prior to lecture to address
any questions
Lecture 60
Cover Duke's policies; stress importance of
following anesthetic and analgesic plan
outlined in the approved protocol
Web
Module
A.L.L. Module +
Quiz "Aseptic
Technique for
Rodent Survival
Surgery"
120
Recommend this prior to lecture to address
any questions
Web
Video
12
http://oacu.od.nih.gov/UsefulResources/AT
TC.wmv
Lecture 30
Cover Duke's policies and STRESS different
requirments of mouse/rat aseptic
procedures (seen in module) and Bird
species
Peri-op
Intra-op
Post-op
Recordkeeping Lecture 30 Cover Duke's policies
Maintenance of the
facility
Review of husbandry
policies
Security
Do's and Don'ts
Protocol compliance
Ensuring death
Total Time:
702 11.7 hours
Lecture 300 5
hours
Web Based 342 5.7
hours
Other 60 1
hours
Lecture covering
the basics of
common
procedures
60
• Focus of this lecture should cover general
considerations for common procedures and
highlight any obvious species specific
diffrences
• Review Duke's policies and procedures
(what ones are available and where to find
them)
• Allow time for specific questions on
species or web module
• Discuss means to request individual or
protocol/species specific training
As the RACC training
program grows,
consider a hands-on
portion that is
protocol/species
specific
Research Animal Coordinator Certification (RACC) Curriculum
Section 2-D
Animal Specific Training: Guinea Pigs
Lecture
Future
Recommendation:
Cover this topic in a
hands-on wet-lab
Surgical Monitoring
Lecture
90
Cover Duke's policies and record
requirements
• Highlight: Peri-op analgesics, fasting,
evaluation of animal condition; Intra-op
monitoring for surgical depth; Post-op
monitoring requirements
Expectations
of care
Pain, anesthesia and
analgesia
• Pain recognition
• Anesthetics,
analgesics,
tranquilizers,
neuromuscular
blocking agents
Aseptic Surgical
Technique
Procedures
Tour to be scheduled with DLAR staff
member, preferable to coordinate with
husbandry supervisor of the area their
animals are housed
Should be required
for RACs from PI
managed areas also;
facility they tour
should have similar
species/housing that
is used in the
laboratory
Euthanasia
Lecture
30
Focus on Duke/IACUC policy and stress
secondary method
DLAR
Husbandry
Tour
60
Topic Sub-topics Format Details Time Notes Exceptions
Species
Specific
Training
Web
Module
A.L.L. Module + Quiz
for ALAT Training
"ALAT 18: Mice"
120
If working with a
species where there is
NOT a A.L.L. module,
one-on-one training
may be required
Handling and Restraint
Injections
Blood withdrawals
Identification
Oral gavage
Web
Module
A.L.L. Module + Quiz
"Pain recognition and
alleviation in
laboratory animals"
90
Recommend this prior to lecture to address
any questions
Lecture
60
Cover Duke's policies; stress importance of
following anesthetic and analgesic plan
outlined in the approved protocol
Web
Module
A.L.L. Module + Quiz
"Aseptic Technique for
Rodent Survival
Surgery"
120
Recommend this prior to lecture to address
any questions
Web
Video
12
http://oacu.od.nih.gov/UsefulResources/AT
TC.wmv
Lecture
30
Cover Duke's policies and STRESS different
requirments of mouse/rat aseptic
procedures (seen in module) and Bird
species
Peri-op
Intra-op
Post-op
Recordkeeping Lecture 30 Cover Duke's policies
Maintenance of the
facility
Review of husbandry
policies
Security
Do's and Don'ts
Protocol compliance
Ensuring death
Total Time:
702 11.7 hours
Lecture 300 5
hours
Web Based 342 5.7
hours
Other 60 1
hours
Lecture covering the
basics of common
procedures
60
• Focus of this lecture should cover general
considerations for common procedures and
highlight any obvious species specific
diffrences
• Review Duke's policies and procedures
(what ones are available and where to find
them)
• Allow time for specific questions on
species or web module
• Discuss means to request individual or
protocol/species specific training
As the RACC training
program grows,
consider a hands-on
portion that is
protocol/species
specific
Research Animal Coordinator Certification (RACC) Curriculum
Section 2-D
Animal Specific Training: Mice
Lecture
Future
Recommendation:
Cover this topic in a
hands-on wet-lab
Surgical Monitoring
Lecture
90
Cover Duke's policies and record
requirements
• Highlight: Peri-op analgesics, fasting,
evaluation of animal condition; Intra-op
monitoring for surgical depth; Post-op
monitoring requirements
Expectations
of care
Pain, anesthesia and
analgesia
• Pain recognition
• Anesthetics,
analgesics,
tranquilizers,
neuromuscular
blocking agents
Aseptic Surgical
Technique
Procedures
Tour to be scheduled with DLAR staff
member, preferable to coordinate with
husbandry supervisor of the area their
animals are housed
Should be required
for RACs from PI
managed areas also;
facility they tour
should have similar
species/housing that
is used in the
laboratory
Euthanasia
Lecture
30
Focus on Duke/IACUC policy and stress
secondary method
DLAR
Husbandry
Tour
60
Topic Sub-topics Format Details Time Notes Exceptions
Species
Specific
Training
Web
Module
A.L.L. Module + Quiz
for ALAT Training
"ALAT 28: Nonhuman
Primates"
120
If working with a
species where there is
NOT a A.L.L. module
for, one-on-one
training may be
required
Handling and Restraint
Injections
Blood withdrawals
Identification
Oral gavage
Web
Module
A.L.L. Module + Quiz
"Pain recognition and
alleviation in
laboratory animals"
90
Recommend this prior to lecture to address
any questions
Lecture
60
Cover Duke's policies; stress importance of
following anesthetic and analgesic plan
outlined in the approved protocol
Web
Module
A.L.L. Module + Quiz
"Aseptic Technique for
Rodent Survival
Surgery"
120
Recommend this prior to lecture to address
any questions
Web
Video
12
http://oacu.od.nih.gov/UsefulResources/AT
TC.wmv
Lecture
30
Cover Duke's policies and STRESS different
requirments of mouse/rat aseptic
procedures (seen in module) and Bird
species
Peri-op
Intra-op
Post-op
Recordkeeping Lecture 30 Cover Duke's policies
Maintenance of the
facility
Review of husbandry
policies
Security
Do's and Don'ts
Protocol compliance
Ensuring death
Total Time:
702 11.7 hours
Lecture 300 5
hours
Web Based 342 5.7
hours
Other 60 1
hours
Tour to be scheduled with DLAR staff
member, preferable to coordinate with
husbandry supervisor of the area their
animals are housed
Should be required
for RACs from PI
managed areas also;
facility they tour
should have similar
species/housing that
is used in the
laboratory
Euthanasia
Lecture
30
Focus on Duke/IACUC policy and stress
secondary method
DLAR
Husbandry
Tour
60
Expectations
of care
Pain, anesthesia and
analgesia
• Pain recognition
• Anesthetics,
analgesics,
tranquilizers,
neuromuscular
blocking agents
Aseptic Surgical
Technique
Procedures
Future
Recommendation:
Cover this topic in a
hands-on wet-lab
Surgical Monitoring
Lecture
90
Cover Duke's policies and record
requirements
• Highlight: Peri-op analgesics, fasting,
evaluation of animal condition; Intra-op
monitoring for surgical depth; Post-op
monitoring requirements
Lecture covering the
basics of common
procedures
60
• Focus of this lecture should cover general
considerations for common procedures and
highlight any obvious species specific
diffrences
• Review Duke's policies and procedures
(what ones are available and where to find
them)
• Allow time for specific questions on
species or web module
• Discuss means to request individual or
protocol/species specific training
As the RACC training
program grows,
consider a hands-on
portion that is
protocol/species
specific
Research Animal Coordinator Certification (RACC) Curriculum
Section 2-D
Animal Specific Training: Non-Human Primates
Lecture
Topic Sub-topics Format Details Time Notes Exceptions
Species
Specific
Training
Web
Module
A.L.L. Module + Quiz
for ALAT Training
"ALAT 19: Rats
120
If working with a
species where there is
NOT a A.L.L. module
for, one-on-one
training may be
required
Handling and Restraint
Injections
Blood withdrawals
Identification
Oral gavage
Web
Module
A.L.L. Module + Quiz
"Pain recognition and
alleviation in
laboratory animals"
90
Recommend this prior to lecture to address
any questions
Lecture
60
Cover Duke's policies; stress importance of
following anesthetic and analgesic plan
outlined in the approved protocol
Web
Module
A.L.L. Module + Quiz
"Aseptic Technique for
Rodent Survival
Surgery"
120
Recommend this prior to lecture to address
any questions
Web
Video
12
http://oacu.od.nih.gov/UsefulResources/AT
TC.wmv
Lecture
30
Cover Duke's policies and STRESS different
requirments of mouse/rat aseptic
procedures (seen in module) and Bird
species
Peri-op
Intra-op
Post-op
Recordkeeping Lecture 30 Cover Duke's policies
Maintenance of the
facility
Review of husbandry
policies
Security
Do's and Don'ts
Protocol compliance
Ensuring death
Total Time:
702 11.7 hours
Lecture 300 5
hours
Web Based 342 5.7
hours
Other 60 1
hours
Tour to be scheduled with DLAR staff
member, preferable to coordinate with
husbandry supervisor of the area their
animals are housed
Should be required
for RACs from PI
managed areas also;
facility they tour
should have similar
species/housing that
is used in the
laboratory
Euthanasia
Lecture
30
Focus on Duke/IACUC policy and stress
secondary method
DLAR
Husbandry
Tour
60
Expectations
of care
Pain, anesthesia and
analgesia
• Pain recognition
• Anesthetics,
analgesics,
tranquilizers,
neuromuscular
blocking agents
Aseptic Surgical
Technique
Procedures
Future
Recommendation:
Cover this topic in a
hands-on wet-lab
Surgical Monitoring
Lecture
90
Cover Duke's policies and record
requirements
• Highlight: Peri-op analgesics, fasting,
evaluation of animal condition; Intra-op
monitoring for surgical depth; Post-op
monitoring requirements
Lecture covering the
basics of common
procedures
60
• Focus of this lecture should cover general
considerations for common procedures and
highlight any obvious species specific
diffrences
• Review Duke's policies and procedures
(what ones are available and where to find
them)
• Allow time for specific questions on
species or web module
• Discuss means to request individual or
protocol/species specific training
As the RACC training
program grows,
consider a hands-on
portion that is
protocol/species
specific
Research Animal Coordinator Certification (RACC) Curriculum
Section 2-D
Animal Specific Training: Rats
Lecture
Topic Sub-topics Format Details Time Notes Exceptions
Species
Specific
Training
Web
Module
A.L.L. Module + Quiz
for ALAT Training
"ALAT 26: Swine"
120
If working with a
species where there is
NOT a A.L.L. module
for, one-on-one
training may be
required
Handling and Restraint
Injections
Blood withdrawals
Identification
Oral gavage
Web
Module
A.L.L. Module + Quiz
"Pain recognition and
alleviation in
laboratory animals"
90
Recommend this prior to lecture to address
any questions
Lecture
60
Cover Duke's policies; stress importance of
following anesthetic and analgesic plan
outlined in the approved protocol
Web
Module
A.L.L. Module + Quiz
"Aseptic Technique for
Rodent Survival
Surgery"
120
Recommend this prior to lecture to address
any questions
Web
Video
12
http://oacu.od.nih.gov/UsefulResources/AT
TC.wmv
Lecture
30
Cover Duke's policies and STRESS different
requirments of mouse/rat aseptic
procedures (seen in module) and Bird
species
Peri-op
Intra-op
Post-op
Recordkeeping Lecture 30 Cover Duke's policies
Maintenance of the
facility
Review of husbandry
policies
Security
Do's and Don'ts
Protocol compliance
Ensuring death
Total Time:
702 11.7 hours
Lecture 300 5
hours
Web Based 342 5.7
hours
Other 60 1
hours
Tour to be scheduled with DLAR staff
member, preferable to coordinate with
husbandry supervisor of the area their
animals are housed
Should be required
for RACs from PI
managed areas also;
facility they tour
should have similar
species/housing that
is used in the
laboratory
Euthanasia
Lecture
30
Focus on Duke/IACUC policy and stress
secondary method
DLAR
Husbandry
Tour
60
Expectations
of care
Pain, anesthesia and
analgesia
• Pain recognition
• Anesthetics,
analgesics,
tranquilizers,
neuromuscular
blocking agents
Aseptic Surgical
Technique
Procedures
Future
Recommendation:
Cover this topic in a
hands-on wet-lab
Surgical Monitoring
Lecture
90
Cover Duke's policies and record
requirements
• Highlight: Peri-op analgesics, fasting,
evaluation of animal condition; Intra-op
monitoring for surgical depth; Post-op
monitoring requirements
Lecture covering the
basics of common
procedures
60
• Focus of this lecture should cover general
considerations for common procedures and
highlight any obvious species specific
diffrences
• Review Duke's policies and procedures
(what ones are available and where to find
them)
• Allow time for specific questions on
species or web module
• Discuss means to request individual or
protocol/species specific training
As the RACC training
program grows,
consider a hands-on
portion that is
protocol/species
specific
Research Animal Coordinator Certification (RACC) Curriculum
Section 2-D
Animal Specific Training: Swine
Lecture
Topic Sub-topics Format Details Time Notes Exceptions
Species
Specific
Training
Web
Module
A.L.L. Module + Quiz
for ALAT Training
"ALAT 23: Rabbits"
120
If working for a
species where there is
NOT a A.L.L. module
for, one-on-one
training may be
required
Handling and Restraint
Injections
Blood withdrawals
Identification
Oral gavage
Web
Module
A.L.L. Module + Quiz
"Pain recognition and
alleviation in
laboratory animals"
90
Recommend this prior to lecture to address
any questions
Lecture
60
Cover Duke's policies; stress importance of
following anesthetic and analgesic plan
outlined in the approved protocol
Web
Module
A.L.L. Module + Quiz
"Aseptic Technique for
Rodent Survival
Surgery"
120
Recommend this prior to lecture to address
any questions
Web
Video
12
http://oacu.od.nih.gov/UsefulResources/AT
TC.wmv
Lecture
30
Cover Duke's policies and STRESS different
requirments of mouse/rat aseptic
procedures (seen in module) and Bird
species
Peri-op
Intra-op
Post-op
Recordkeeping Lecture 30 Cover Duke's policies
Maintenance of the
facility
Review of husbandry
policies
Security
Do's and Don'ts
Protocol compliance
Ensuring death
Total Time:
702 11.7 hours
Lecture 300 5
hours
Web Based 342 5.7
hours
Other 60 1
hours
Lecture covering the
basics of common
procedures
60
• Focus of this lecture should cover general
considerations for common procedures and
highlight any obvious species specific
diffrences
• Review Duke's policies and procedures
(what ones are available and where to find
them)
• Allow time for specific questions on
species or web module
• Discuss means to request individual or
protocol/species specific training
As the RACC training
program grows,
consider a hands-on
portion that is
protocol/species
specific
Research Animal Coordinator Certification (RACC) Curriculum
Section 2-D
Animal Specific Training: Rabbits
Lecture
Future
Recommendation:
Cover this topic in a
hands-on wet-lab
Surgical Monitoring
Lecture
90
Cover Duke's policies and record
requirements
• Highlight: Peri-op analgesics, fasting,
evaluation of animal condition; Intra-op
monitoring for surgical depth; Post-op
monitoring requirements
Expectations
of care
Pain, anesthesia and
analgesia
• Pain recognition
• Anesthetics,
analgesics,
tranquilizers,
neuromuscular
blocking agents
Aseptic Surgical
Technique
Procedures
Tour to be scheduled with DLAR staff
member, preferable to coordinate with
husbandry supervisor of the area their
animals are housed
Should be required
for RACs from PI
managed areas also;
facility they tour
should have similar
species/housing that
is used in the
laboratory
Euthanasia
Lecture
30
Focus on Duke/IACUC policy and stress
secondary method
DLAR
Husbandry
Tour
60
Revised June 04, 2013
RACC Mouse Procedures Training Form
Procedure
Participant’s
Initials
Instructor’s
Initials
Handling & restraint
Intraperitoneal (IP) injections
Subcutaneous (SC) injections
Intravenous (IV) injections (tail vein)
Submandibular blood collection
Oral gavage
Euthanasia (CO2 followed by bilateral thoracotomy)
Cardiac puncture (post CO2 euthanasia)
Aseptic Technique
Participant: ___________________________________________________________
Print Name Initials
Participant Signature: ___________________________________________________
What lab do you work in at Duke? _________________________________________
Instructor: ___________________________________________________
Amy McArdle
Date of Training: _____________________________
Duke University Medical Center
Research Animal Coordinator Training and Certification Program
Application
The Duke University Animal Care and Use Program (ACUP) is hosting the Research Animal Coordinator Training
and Certification Program. This program is designed to enhance an individual’s knowledge of important animal
research topics and facilitate smooth and efficient animal based research in the laboratory. Training includes
federal regulations, Duke’s policies, animal handling and welfare principles. Successful individuals will be
certified as a coordinator within their laboratory to disseminate knowledge, provide training, speed-up protocol
processing, and ensure animal welfare and protocol compliance within their laboratory.
To enroll in the RAC training program please complete this form and e-mail it to w.wa[email protected] or fax it to
919.668.6725. Enrollment is limited to one person per laboratory or per principal investigator.
1. Name of laboratory member (applicant): ______________________________________________________
• Educational background and/or degrees: _______________________________________________
• Contact number: ___________________________________________________________________
• Email address: _____________________________________________________________________
2. Principal investigator recommending this applicant: _____________________________________________
• Contact number: ___________________________________________________________________
• Email address: _____________________________________________________________________
3. Protocol number(s) associated with this laboratory: ______________________________________________
• Animal species on protocol(s):_________________________________________________________
• Animal procedures on these protocols (please indicate which species the procedure will be
performed on if using >1 species):
__________________________________________________________________________________
__________________________________________________________________________________
• Some/all animals in this laboratory or under these protocols are housed in laboratory space and
husbandry services are provided by the PI or laboratory staff (i.e., they are not in a DLAR managed
area) Yes No (choose one)
4. The principal investigator should approve this application by hard copy signing this application, providing an
electronic signature, or sending an email endorsement for the applicant to participate in the Research
Animal Coordinator Certification Program. Eligibility criteria for RACC applicants:
• Be approved by a Duke principal investigator
• Be a permanent employee of Duke University
• Have a role within the laboratory of animal care/use oversight, management, care, or research (e.g.,
lab manager, senior lab associate, principal lab person, primary lab contact, responsible person for
animal care)
Signature of the applicant: ______________________________________ Date: ___________________
Signature of the principal investigator: _____________________________
Date: ____________________
<NOTE: DOCUMENTS SENT FROM A ‘DUKE.EDU’ EMAIL ADDRESS ARE CONSIDERED ELECTRONICALLY SIGNED>
Need More Info?
If you would like more information on the Research Animal Coordinator Training and Certification Program,
including an outline of all required courses and evaluation requirements, please contact: Bill Wade at
w.wade@duke.edu
or 668.6722
DUKE UNIVERSITY ANIMAL CARE AND USE PROGRAM
RESEARCH ANIMAL COORDINATOR CERTIFICATION PROGRAM
PRE-COURSE SURVEY
Please take a few moments to fill out this pre-course survey. This information will help us in preparing
future course modules and allow us to provide current, practical information for the course participants.
1. Is the species of animal you work with covered by any of the federal regulations, and if so which one?
2. Which federal animal use ‘policy’ governs NIH funded activity with animals?
3. What federal agency provides the most funding for biomedical research?
4. Who is ultimately responsible for all research conducted on animals under an IACUC approved protocol?
5. Under what circumstances can the IACUC suspend an animal model protocol?
6. How often must protocols be reviewed? And by whom must they be reviewed?
7. What information do you particularly hope to receive from the program?
8. Who is your departmental representative to the IACUC?
9. What is the proper method to capture and transport a mouse?
10. Describe the difference (if any) between an animal rights and animal welfare activist.
11. What is a ‘humane endpoint?’
12. What is the difference between IACUC Policies and IACUC Suggestions?
13. Where could you find guidance on the maximum amount of blood you can collect from a mouse?
14. What is the web address for:
a. Animal Program Website?
b. DLAR Website?
15. What disinfecting agents are safe around animals, but kill microbes?
16. What are the important environmental parameters for:
a. Aquatics ?
b. Reptiles?
c. Mammals?
17. Euthanasia is the act of (complete sentence):
18. Diseases in my animals which can have negative research impact without showing signs of disease
include:
19. Concerning the concepts of ‘pre-emptive analgesia’ and pre-emptive antibiotics’ :
a. Are important because:
b. Are employed how:
20. What are the ‘Animal Tracks?’
DUKE UNIVERSITY
ANIMAL CARE & USE PROGRAM
RESEARCH ANIMAL COORDINATOR
HAS COMPLETED THE RESEARCH ANIMAL COORDINATOR CERTIFICATION
PROGRAM
Date
_______________________ ________________________
Laura Hale, MD, PhD Bill Wade, LVT, RLATG, CPIA
IACUC Chair Education & Training Liaison
