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Animal Use Protocol (AUP) (Application form Instructions) 1. Please refer to the NTU-IACUC Policies for Special Procedures before submitting this application. 2. In order to perform its obligations in accordance with the NTU-IACUC Policies for Special Procedures, it needs a complete description of the proposed animal use and care. Incomplete application will be returned to the applicant resulting in delay in the granting of approval. 3. Submit the completed form together with the soft copy of required documents. 4. Any changes to the approved Animal Use Protocol (AUP) (procedure, species, personnel, etc.) must be documented through submission of an Amendment Form and approved by the NTU-IACUC before implementation. a) Any SIGNIFICANT changes to an approved project in progress (e.g. the inclusion of new procedures involving potential pain, surgery or anaesthetization, or a change in Principal Investigator or course director) require IACUC review (and approval) prior to initiation. b) Any NON-SIGNIFICANT changes to an approved project in progress (e.g. increase in number of animals used within 15%, changes in location of experiment or changes in personnel) require administrative review (and approval) prior to initiation. 5. Approval of AUP will be for a maximum of 3 years. Extension can only be granted one time for a maximum of 6 months with the approval of the NTU-IACUC. Following this, a new application is required. 6. For animal deliveries please ensure Facilities Director is informed. 7. NTU-IACUC reviews applications monthly so please ensure that this completed form, along with necessary supporting documents, are submitted by the first working day of a month so as to be reviewed the following month. All reviews by NTU-IACUC are on a first come, first served basis. 8. Manuscripts submitted to journals that are based on work done on an approved AUP must include reference to the approving institute and corresponding AUP number. Version: V06 Effective Date: 23 Aug 2018 Document Number: NTU-IACUC-SOP-1.1-F01 Document Name: NTU-IACUC AUP Application Form 1

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Animal Use Protocol (AUP) (Application form Instructions)

1. Please refer to the NTU-IACUC Policies for Special Procedures before submitting this application.

2. In order to perform its obligations in accordance with the NTU-IACUC Policies for Special Procedures, it needsa complete description of the proposed animal use and care. Incomplete application will be returned to the applicant resulting in delay in the granting of approval.

3. Submit the completed form together with the soft copy of required documents.

4. Any changes to the approved Animal Use Protocol (AUP) (procedure, species, personnel, etc.) must bedocumented through submission of an Amendment Form and approved by the NTU-IACUC before implementation.

a) Any SIGNIFICANT changes to an approved project in progress (e.g. the inclusion of new procedures involvingpotential pain, surgery or anaesthetization, or a change in Principal Investigator or course director) require IACUC review (and approval) prior to initiation.

b) Any NON-SIGNIFICANT changes to an approved project in progress (e.g. increase in number of animals usedwithin 15%, changes in location of experiment or changes in personnel) require administrative review (and approval) prior to initiation.

5. Approval of AUP will be for a maximum of 3 years. Extension can only be granted one time for a maximum of6 months with the approval of the NTU-IACUC. Following this, a new application is required.

6. For animal deliveries please ensure Facilities Director is informed.

7. NTU-IACUC reviews applications monthly so please ensure that this completed form, along with necessarysupporting documents, are submitted by the first working day of a month so as to be reviewed the following month. All reviews by NTU-IACUC are on a first come, first served basis.

8. Manuscripts submitted to journals that are based on work done on an approved AUP must include referenceto the approving institute and corresponding AUP number.

Version: V06Effective Date: 23 Aug 2018Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

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Select the AUP application type

New Submission

Renewal

Document title:

Select all that apply

Research

Pilot Study

Breeding Protocol

Teaching

Others

Start Date (DD-MM-YYYY):

End Date (DD-MM-YYYY):

1a. AUP Application Type

1b. Project Title

1c. Project Category

1d. Proposed Project Duration

Project is valid for a maximum of 3 years.

Application number of protocol to be renewed and reason(s) for renewal: *

Version: V06Effective Date: 23 Aug 2018Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

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If user(s) to be added is/are not available in selection lists, please provide the following details of user(s) to be added:

Provide the names of all personnel who will oversee or conduct work under this protocol. Click on "Edit selection" to add users to each category.

2a. Principal Investigator (PI)/Course Instructor

PI / Course Instructor here refers to the main person responsible for the care and use of animals in this

protocol. The PI must be the grant holder.

Last name First name

2b. Emergency Contact(s)

Animal facility staff will try to contact personnel listed in this section whenever an animal is found in moribund condition, in pain or distress. However, NTU-IACUC is not responsible for any animals that, in the professional opinion of the Attending Veterinarian, are suffering in excess of the pain and distress limits approved for this protocol, and which are subsequently euthanized for humane reasons to alleviate further suffering.

In the event that animals have to be euthanized by the Attending Veterinarian without the knowledge of the PI / emergency contact personnel, indicate on cage cards whether the Attending Veterinarian and his staff are to assist in collecting any of the following tissue samples:

a) Type of tissue samples to be collected

b) Harvesting procedures

c) Storage conditions of harvested tissue samples

2c. Co-Investigator(s)

List the names of all other individuals (besides the PI) authorised to conduct procedures involving animals under this protocol.

Last name First name

2d. Research Personnel

Research Personnel conduct research procedures using animals under this protocol.

2e. Pre-Reviewer

Pre-Reviewers are required to perform a pre-review of the protocol as assigned by the PI. The Pre-Reviewer is the ACR or ADR of the School or College respectively.

First name

2f. Request Addition of a New User

First Name Last Name e-mail Contact N0

Last name

First name Last name

First name Last name

Version: V06Effective Date: 23 Aug 2018Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

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Grant Type

Grant Title

Others

Funding Status

Awarded

Period of grant validity (DD-MMM-YYYY):

Pending

Others

Funding

Awarded Date Expiry Date

Version: V06Effective Date: 23 Aug 2018Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

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Species

4a. Animal Characteristics

Age at Acquisition

Weight at Acquisition (metric)

Number Housed at Any One Time

Strain

4b. Animal Source (Local/Overseas, Address)

4c. Housing Location

4d. Other Descriptions (State any other information relevant to animals allocated)

4e. Breeding Plan (Determine and describe the number of breeding pairs you need to supply sufficient mice for your experiments)

Version: V06Effective Date: 23 Aug 2018Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

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(i

(i) Specific Objectives of the Project

(ii) Project Abstract

(iii) Attach a Flowchart of Experimental Procedures and Timelines * (*)

I have attached a flowchart

No flowchart attached

v) Significance of Expected Benefits to Humans or Animals

Lay Description

List in point form

250 words or less, using simple language, avoiding the use of scientific/medical jargon

The flowchart should give a clear overview of the experimental plan for the animals from entry into the project to proposal's endpoint, with timelines clearly indicated.

Version: V06Effective Date: 23 Aug 2018Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

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Use one of the following web-sites to assist / justify your searches

1. National Centre for the Replacement, Refinement and Reduction of Animals in Research

2. USDA Animal Welfare Information Centre, Alternatives and Searches

3. Alternatives to Animal Testing on the Web

4. Johns Hopkins University Centre for Alternatives to Animal Testing

5. European Union Reference Laboratory for Alternative to Animal Testing

6. Fund for the Replacement of Animals in Medical Research (FRAME)

The IACUC requires “that animals should be used only if the researcher’s best efforts to find an alternative have failed”. The three Rs (Replacement, Reduction and Refinement) are the cornerstone of ethical animal research, and NTU-IACUC requires investigators to implement the 3Rs when they are preparing to use animals for scientific or teaching purposes.

6a. Describe the results of searches conducted to verify that the proposed work is not an unnecessary duplication of previous work done.

Search Data

Add literature search information.

Search Searched Keywords Searched to DB Title # of hits conducted from searched

Based on search results obtained, how will the experiments outlined in this protocol be tailored to avoid duplication of earlier work done?

6b. Alternative non-animal methods

Are there any alternative non-animal methods used by other investigators for the type of work proposed in this AUP (e.g. tissue cultures, in vitro monoclonal antibody, computer model, etc)?

Yes

No

6c. Why must animals be used in these experiments?

Select all that apply

This is a study of animal behaviour

This phenomenon under study cannot be reproduced in vitro

This is a pre-clinical study of the in vivo effectiveness of a treatment or procedure

This is for teaching

Others

Describe why these alternatives are not appropriate for this project.

Please elaborate:

IMPORTANT: Retain all search data on file for the duration of the AUP

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6d. Species Characteristics

What characteristics of this/these species make them appropriate for the proposed study? *

These might include structural, behavioural, physiological, biochemical, or other features or considerations (such as availability of species-specific reagents, or the use of well-established model) which make the model compatible with the research objectives. Cost is not a primary consideration.

6e. Reduction, replacement and refinement: How have you considered the 3Rs?

(i) Reduction: Describe how you have attempted to reduce the number of animals. *

(ii) Replacement: Have you considered statistical models in vitro work, instead of using animals etc.? Please describe. *

(iii) Refinement: Have you considered pilot studies, how have you refined any surgical procedures or other manipulations? Please describe. *

Version: V06Effective Date: 23 Aug 2018Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

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Pain Classification

Classification 1

Number of animals/year

Classification 2

Number of animals/year

Classification 3

Number of animals/year

Classification 4

Number of animals/year

Total number of animals requested

*

7a. Classification of Pain/ Distress

NO pain, distress, or use of pain-relieving drugs. Routine procedures (e.g. injections, tattooing, blood sampling) should be reported with this classification.

Species Strain YEAR 1 YEAR 2 YEAR 3 Remarks

Accompanying pain or distress to the animals for which appropriate anaesthetics, analgesics, or tranquillising drugs will be used.

Species Strain YEAR 1 YEAR 2 YEAR 3 Remarks

Accompanying pain or distress to the animals for which the use of appropriate anaesthetics, analgesic, or tranquillising drugs would have adversely affected the procedures, results, or interpretation of the research, experiments, surgery

Species Strain YEAR 1 YEAR 2 YEAR 3 Remarks

Animals being bred, conditioned, or held for scientific activities at each facility but not yet used for research purposes.

Species Strain YEAR 1 YEAR 2 YEAR 3 Remarks

Complete the table below to indicate the total number of animals requested per year. This should be a sum of the annual number requested under the selected pain categories:

Species Strain YEAR 1 YEAR 2 YEAR 3 Remarks

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7b. (only for Classification 3)

Explain the procedures producing pain or distress in these animals and justify why appropriate anaesthetic, analgesic or tranquilising drugs cannot be used.

*

If pregnant animals are used, describe how you will take care of the offspring. *

7c. Please justify the number of animals used as stated in section 7.a.

Provide a breakdown of how the total numbers are arrived at and explain the distribution of animal numbers across different procedures or experimental groups. *

If statistics are used (e.g. c2 test, Fisher’s Exact test, Student’s t-test, ANOVA), describe the statistical analysis.

7d. Use of pregnant animals

Version: V06Effective Date: 23 Aug 2018Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

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*

Name of study segment:

Species:

Overview

In the field "Name of study segment", enter the AUP title. Expand the "Species" field and select all the species reflected under this application and click "Apply". Lastly, select "Add".

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No. of entries:

No. of entries:

Will food/fluid or both be restricted for the animal(s) used?

Yes *

Provide additional details, including (i) duration of restriction, (ii) possible effects on the animal, (iii) how the animal’s health and well-being will be assessed during this period and (iv) why positive reinforcement is not a suitable substitute:

No

Will the animal be restrained conscious for a continuous period exceeding 15 minutes?

Yes *

Provide additional details, including (i) description of the restraint, (ii) duration of restraint and (iii) how the animal will be observed during this period.

If the duration exceeds 6 hours and the animal’s ability to access food and water is limited, provide the following information:

No

Click on "Add/edit procedures" below to select from a list of pre-determined non-surgical procedures. Each procedure will correlate to a training competency under the "Procedures Training Verification" module. If a non-surgical procedure is not listed, manually describe your procedure; note there is no automatic link to training and you will need to document additional training details under the "Procedures Training Verification" module.

List of Non-Surgical Procedures

Description Species

Description of Non-Surgical Procedures

In LAY LANGUAGE, describe each procedure listed above. The following must be included clearly for each procedure, where applicable: Liquids - Volume, Concentration, Route of Administration, Frequency Implants - Dimensions, Size

Others

(a) when food and water will be given (b) how body weight will be monitored (c) how hydration status will be monitored

Version: V06 Effective Date: 23 Aug 2018 Document Number: NTU-IACUC-SOP-1.1-F01 Document Name: NTU-IACUC AUP Application Form

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Describe the relevant experience and training to qualify operator(s) in performing this surgery:

Complete this table for those with insufficient / no surgical experience on the relevant animal species:

Surgical considerations:

(i) How are surgical instruments sterilised and how is the sterility maintained?

(ii) Has adequate consideration been given to asepsis? Describe the method(s) for sterilising the surgical site and instruments?

(iii) How is the site closed (including all layers)? Describe sutures used and suture method.

(iv) Where will the procedure be conducted?

(v) If clips or non-absorbable sutures are used, when will they be removed?

(vi) How will the animals be monitored over the 72 hours post-surgery? How will records of this monitoring be carried out?

Nature of surgical procedure

Survival

Non-survival

Will multiple surgeries be carried out on animal(s)?

Yes

Provide scientific justification for Multiple Survival Surgical Procedures (MSSP) to be performed on the animal(s):

State the periods between respective surgeries: *

No

Summary of Surgical Procedures

Complete this section if surgical procedures will be performed on animals.

Surgical Procedures

Name of Surgeon(s) Experience in Carrying out Surgical Procedures in Lab Animals

Name of Trainee(s) Name and Experience of Trainer

Title of procedure Description of procedure Pain classification, if applicable

Describe relevant anaesthesia / analgesia administered

Number of animals affected

Personnel

performing

Version: V06 Effective Date: 23 Aug 2018 Document Number: NTU-IACUC-SOP-1.1-F01 Document Name: NTU-IACUC AUP Application Form

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Personnel Training / Vaccination Requirements

Select the relevant training and vaccinations required.

AUP Training

RCULA Theory Certification

RCULA Practical Certification

Status

The selected training and vaccination are required for all personnel prior to protocol submission and approval. The matrix below shows the current status of these requirements for personnel added to this protocol.

Under Status, the availability of certification and vaccination information is reflected. If any item is indicated with a NO, provide relevant document/update to IACUC Secretariat so that the user’s profile can be updated.

Tentative Training and Vaccination Dates

Select the vaccinations applicable to this study

Tetanus (compulsory for work with rodents)

Hepatitis B (compulsory for work with rodents)

Measles (compulsory for work with primates)

All personnel listed must have undergone RCULA training and have the necessary vaccinations. If RCULA training or vaccination are not complete, state tentative completion dates:

RCULA Training

Personnel Tentative training date (dd/mm/yyyy)

Vaccination

Personnel Vaccination Tentative vaccination date (dd/mm/yyyy)

Version: V06Effective Date: 23 Aug 2018Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

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9a.Experimental animal use endpoint

Describe when (use time line, clinical sign, etc) the EXPERIMENTAL ENDPOINT for EACH group of animals will be.

All animals (as described in Section 7) must be covered by an endpoint. (not to be confused with humane endpoints).

9b. Death as an experimental endpoint

Will death the experimental endpoint for any group of animals?

Yes

Please provide justification as to why an alternative to death cannot be used as an endpoint:

No

Version: V06Effective Date: 23 Aug 2018Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

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Indicate any clinical conditions or abnormalities expected or that could arise as a result of the proposed study or teaching exercise

In terms of species-specific behavioural changes and physiological signs, list the criteria that will be used to trigger the decision to remove an animal from the teaching exercise or experiment, or to terminate the teaching exercise or experiment.

Select all the humane endpoints that apply:

Tumour size

Specify maximum growth (cm):

Weight loss (more than 20% of bodyweight over 1 week OR no more than 10% over 24 hrs)

Inability to drink or eat

Abnormal behavior such as vocalization, CNS signs, shivering, immobility, inactiveness

Clinical symptoms (e.g. lameness, ruffled fur/coat, dyspnea, vomiting, edema, discharges)

Signs of Toxicity

Wound infection/dehiscence(breakdown)

Vomiting of blood (Haematemesis): NOT applicable to rodents

Severe bleeding

Severe or chronic pain

Others:

e.g. behavioural changes such as increased grooming, vocalization or postural changes, or physical abnormalities such as anorexia, dehydration, diarrhoea, etc.

If necessary, consult the Attending Veterinarian for further advice.

10a. Clinical conditions or abnormalities expected from proposed study

When experimental procedures produce animals that may become ill, it is necessary to define an endpoint to ensure that an experimental animal's discomfort, pain and/or distress is terminated, minimized or reduced.

10b. Criteria for animal removal from study

10c. Humane Endpoints

Version: V06Effective Date: 23 Aug 2018Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

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State how animals that have arrived at humane endpoints will be treated

10e. Treatment of animals at humane endpoint

10f. Other comments

Indicate frequency of observation and person(s) in charge:

10d. Animal Monitoring

Version: V06Effective Date: 23 Aug 2018Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

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11a. Indicate how carcasses are to be disposed of after completion of the project/research.

Anaesthetic overdose

State the agent that will be used:

CO2

Exsanguination (under anaesthesia)

Cervical dislocation

Justify why physical methods have to be used and state the location where it will be done:

Decapitation

Justify why physical methods have to be used and state the location where it will be done:

Others

Euthanasia [select preferred technique(s)]:

11b. Specify the method of carcass disposal. Include method of disposing contaminated organs/tissues.

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(i) Is Recombinant DNA or transgenic animal used?

Yes

No

(ii) Is Lentiviral vector used?

Yes

No

(iii) Proposed category of GMAC work:

Cat. A

Cat. B

Cat. C

List all genetic constructs for Genetically Engineered Animals used on this protocol.

GMAC approval must be obtained and attached to this section tab

3rd generation lentivirus vector are exempt from BATA. Please select ABSL2 for biosafety level. Please note that a maximum of 100ml of Lentivirus culture may be brought to NTU and that there should be no storage within the facility.

The Singapore Biosafety Guidelines for Research on Genetically Modified Organisms (GMOs) can be accessed for further information: http://www.gmac.gov.sg/Index_Singapore_Biosafety_Guidelines_for_Research_on_GMOs.html Or please contact the GMAC Secretariat: [email protected]

List all Radiological Hazards used on this protocol.

Complete the table below and attach appropriate license(s) for the use of these radioactive substances.

List all Chemical Hazards used on this protocol.

Complete all the relevant sections below if this AUP uses any of the following material(s). Indicate the nature of the material(s) and biological safety levels where appropriate. Prior to the start of the experiment involving the use of potentially hazardous material at NTU, the PI and/or his /her staff must inform the room technician and ARF safety officer the nature of the work and material(s) used. All cages must be labelled with the material used, start date, estimated end date, and contact details of user. All activities within the AUP must be covered by a Risk Assessment (RA) and please provide the approved RA with the application.

1) Potentially Hazardous Materials

A. Genetically Modified Organisms (GMOs)

B. Radioactive Substances

(i) Are radioactive substances used?

No

Yes

Please select an item for each mandatory (*) section and provide a text where necessary.

(i) Are chemical substance(s) used?

Appropriate Safety Data Sheet (SDS) for the chemical(s) used must be included as well as SOP on waste management.

A copy of NTU’s Cytotoxic and ABSL2 Waste Handling SOP can be requested from NTU-LKCMedicine ARF safety officer for this AUP’s

waste management consideration.

Note: ONLY WORKING VOLUME MAY BE BROUGHT INTO THE ANIMAL FACILITY. NO STORAGE OF CHEMICAL IS PERMITTED

WITHIN THE FACILITY.

Yes

Isotope Half Life Maximum dose/volume Carcass waste generation (kg/month)

C. Chemical Substances and New Chemical Entities

GMAC reference number:Proposed category of GMAC works:

Cat. ACat. BCat. C

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iii

If yes, please provide information on chemical substance used in this AUP in the table below:

No

(ii) Are new Chemical Entity(ies) {NCE}/pharmaceutical substance(s) used

Yes

If new chemical entities are to be tested, describe preliminary steps/ tests undertaken to ensure that pain and

distress are minimised during the proposed study:

*

No

If yes, please provide all SDS and relevant waste handling SOPs.

A copy of NTU's Cytotoxic and ABSL2 Waste Handling SOP can be requested from NTU-LKCMedicine ARF safety officer for

this AUP's management consideration.

Note: ONLY WORKING VOLUME MAY BE BRIUGHT INTO THE ANIMAL FACILITY.

NO STORAGE OF CHEMICAL IS PERMITTED WITHIN THE ANIMAL FACILITY.

* Please provide information on NCE/pharmaceutical substance used in this AUP in the table below. Any changes to the listed

compounds will require an amendment to your AUP

Commercial Name Generic Name Maximum dose/ volume

Classification (eg: cytotoxic drugs, antibiotics / hormones)

Known Hazardous Metabolites (if applicable)

iii. Applicable ONLY if chemicals classified under the following categories are introduced or used in this AUP:

(a) Chemical agents / drugs / substances / mixtures that fall under the following description:

◦ Carcinogenicity ◦Cytotoxicity

◦Germ Cell Mutagenicity

◦Reproductive Toxicity

◦Teratogenicity

◦ Globally Harmonized System (GHS) Health Hazard (if applicable)

*

Chemical Name CAS Number

Classification(eg:. oxidant/flammables/toxic/teratogen/mutagen/carcinogen/teratogen/

reproduction/hazard/explosives etc

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(b) Novel Compound or NCEs

Comment

Please justify and submit supporting document for alternative Waste Management Procedure for IACUC review and

consideration.

Justification:

Describe waste disposal methodology in the Comment box if different from NTU’s Cytotoxic and ABSL2 Waste Handling SOP. Please

also justify the reason for the different method used.

Chemical Name Risk Group Carcass waste generation (kg/month)

D. Human Derived Materials

New restrictions are in place with regards to the use of human derived materials under the Human Biomedical Research Act. All use of human material in animals will require you to file for IRB approval. IRB approval letter must be included in the AUP application or amendment. Restricted human biomedical research is defined in the Fourth Schedule of HBRA and these include:

1. Human biomedical research involving human eggs or human embryos 2. Human biomedical research involving —

(a) the following types of human-animal combination embryos:

(i) cytoplasmic hybrid embryos;

(ii) human-animal combination embryos created by the incorporation of human stem cells (including induced pluripotent stem cells);

(iii) human-animal combination embryos created in-vitro by using —

◾ human gametes and animal gametes; or ◾ one human pronucleus and one animal pronucleus; ◾ the introduction of human stem cells (including induced pluripotent stem cells) into a prenatal animal foetus or

animal embryo;

◾ the introduction of human pluripotent stem cells (including induced pluripotent stem cells) into a living postnatal animal;

◾ the introduction of human stem cells (including induced pluripotent stem cells) or human neural cells into the brain of a living postnatal animal; or

◾ any entity created as a result of any process referred to in sub paragraphs (b), (c) and (d)

For human-derived materials requiring IRB approval, please contact the Secretariat of the NTU Institutional Review Board (IRB) at (65)

65922495 or email at [email protected]. The IRB approval letter obtained should include the use of human cells in animals.

Research involving the use of commercial cell lines (excluding embryonic and other stem cells) will not require NTU-IRB approval

for exemption. Principal Investigators will only need to complete and submit an E-Declaration form to the NTU-IRB via email at

[email protected]. The E-declaration form is obtainable from NTU-IRB office. Please forward the E-declaration form and acknowledgement

letter from NTU-IRB to NTU-IACUC office for record keeping.

HBRA Regulatory Framework

FAQs on HBRA

A copy of NTU’s Cytotoxic and ABSL2 Waste Handling SOP can be requested from NTU-LKCMedicine ARF safety officer for this AUP’s

waste management consideration.

Please select ABSL2 for biosafety level (See section H – Overall Animal Biosafety Level).

Comment

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Pl c

(i) Are Materials Defined as per Items 2a-2e Used?

Yes * IRB Application Number:

* IRB Application Approval Date:

Please list and provide information on all human derived materials (examples includes but not limited to ell lines, human stem cells, tissues, etc.) used in this AUP in the table below:

Name Source of Supply (e.g.: from)

E. Non-Human Derived Materials

Are Other Biologically-Derived Materials Used?

Yes

Complete the table below and attach relevant documents

Name of non-human biologically derived material used Source of Supply (eg,:from)

Carcass waste generation (kg/month)

List all human or animal derived Biologicals or Cell Lines used on this protocol.

Date, late MAP test IBC Protocol # IBC Approval Date Source

(i) Are Biological Agent(s) or Toxin(s) Used?

Yes

Please provide information on biological agent(s) or toxin(s) used in this AUP in the table below:

Name Strain / LD50

(for toxins) Supply Source

Select the schedule in Biological Agents and Toxins Act (BATA), if applicable:

First Schedule Part I

First Schedule Part II

Second Schedule

Third Schedule

Fourth Schedule

Fifth Schedule

Not applicable

No

No

No

F. Biological Agent and/or Toxins(s)

Biological or Cell Line

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G. Other Inorganic or Organic Materials Used

Are Other Inorganic or Organic Materials Used?

Yes

Provide toxicity and disposal information; attach necessary documentation:

Complete the table below:

Provide information on other inorganic or organic materials used:

e.g. microchip implantation, gel matrix implantation, etc.

Name Toxicity Information Source of Supply

No

H. Overall Animal Biosafety Level

Overall Animal Biosafety Level and Relevant Chemical Safety Classification

ABSL1

ABSL2

ABSL3

Other Comments

Only applicable if GMOs / human derived materials / biological agents / toxins are introduced or used in this AUP. Attach a risk assessment for all the procedures mentioned in this application including transfer of animals, if any.

2) Staff Health

It is the responsibility of the Principal Investigator (PI) to inform NTU staff of any risks to staff health.

State whether the procedure(s) will result in the release of infectious or non-infectious organisms, and how you intend to handle spills and unused stocks:

Potential hazard to humans:

None

Present

Describe potential health risks to animals or humans

Have you attached a Risk Assessment? (RA)

Yes

No

Specify any special animal care required because of the hazard(s) involved, precautions to be taken by personnel and any special containment requirements (i.e. storage, waste/disposal requirements, etc).

Access the Workplace Risk Assessment System (WRAS) to complete a RA.

Version: V06Effective Date: 23 Aug 2018Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

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3) Declaration of Biological Material / Animal Products for Use in Animals

Yes

No

If derived from humans, materials MUST be tested for Mycoplasma. Such tests must be performed before this application is submitted. Contact NTU ARF for assistance.

To prevent the inadvertent infection of research animals and NTU colonies, declare the origin and sterility status of any biological materials/animal products you intend to use in this AUP:

Complete the table below: *

The listed materials are PCR based or MAP/RAP/HAP/Mycoplasma tested:

Nature of Material (e.g. cell lines, antiserum, etc.)

Animal Source Supplied

Sterile? (Yes/No)

Supplied Attenuated? (Yes/No)

Version: V06Effective Date: 23 Aug 2018Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

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PI Certification

By submitting this form, as the PI you agree to the following terms:

◦ Animals used in this research or teaching project will be cared for in accordance with the principles contained inGuide for the Care and Use of Laboratory Animal (8th Edition)

◦ You have considered alternative procedures that do not involve the use of living animals.

◦ You will use the minimum number of animals consistent with objectives of described research/teaching program.◦ You have carefully selected the species that you propose to use.◦ You will use techniques and facilities that are in accordance with the Guide for the Care and Use ofLaboratory Animal (8th Edition)

◦ You will notify the IACUC of any revisions to this AUP.◦ You will keep copies of all approved AUPs, revisions and amendments in an accessible file.◦ This project has been reviewed for scientific merit.◦ The consultant Attending Veterinarian has been consulted prior to AUP submission / consultation not considerednecessary.

◦ Animals housed in other Satellite Rooms. Animals from external sources need to be quarantined or housed accordingto the revised guidelines on animal quarantine.

◦ Animals will be housed in Animal Facility◦ Facility management has been consulted and has certified that indicated facility(ies) has(have) the resources tosupport this work

Version: V06Effective Date: 23 Aug 2018Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

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