post approval monitoring program n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Post Approval Monitoring Program PowerPoint Presentation
Download Presentation
Post Approval Monitoring Program

Loading in 2 Seconds...

play fullscreen
1 / 22

Post Approval Monitoring Program - PowerPoint PPT Presentation


  • 146 Views
  • Uploaded on

Post Approval Monitoring Program. Presented by Carolyn Malinowski Manager, Quality Assurance and Training . Discussion Areas. What is Post Approval Monitoring Why should we do this Who will be involved Logistics Implementation Questions. Post-Approval Monitoring (PAM).

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Post Approval Monitoring Program' - jana


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
post approval monitoring program

Post Approval Monitoring Program

Presented by Carolyn Malinowski

Manager, Quality Assurance and Training

discussion areas

Discussion Areas

  • What is Post Approval Monitoring
  • Why should we do this
  • Who will be involved
  • Logistics
  • Implementation
  • Questions
post approval monitoring pam

Post-Approval Monitoring (PAM)

  • PAM is a program through which ACUC/CCM can ensure and document program integrity, compliance with regulations and guidelines, and adherence to protocol.
  • PAM can serve as a facilitator or conduit for information exchange between researchers, and between researchers and ACUC/CCM
  • PAM can serve as the eyes and ears of the ACUC
slide4

PAM can provide assurance to regulatory agencies and Northwestern University that animal experiments are monitored for compliance with approved ACUC protocols

goals

Goals

  • Ensure animal well being
  • Protect the Institution
  • Resource for the research community
  • Facilitate science
  • Ensure regulatory compliance
what pam is not

What PAM is NOT

  • NOT Animal Cops
  • NOT a replacement for the ACUC
  • NOT required by the USDA or PHS
  • NOT a “must” of AAALAC
  • NOT new ground or a new regulation
regulatory basis

Regulatory Basis

  • USDA: 2.31 IACUC Functions
  • Public Health Service (PHS)
  • The ‘Guide for the Care and Use of Laboratory Animals’
  • U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training
usda 2 31 iacuc functions

USDA: 2.31 IACUC Functions

  • Review, at least once every 6 months, the research facility’s program for the humane care and use of animals…
  • Inspect, at least once every 6 months, all of the research facilities, including animal study areas…
slide9

3. …The IACUC may determine the best means of conducting evaluations of the research facility’s programs and facilities…

4. …Investigate concerns involving the care and use of animals at the research facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees…

public health service

Public Health Service

1. … Review at least once every 6 months the institution’s program for humane care and use of animals…

2. … The IACUC shall confirm that the research project will be conducted in accordancewith the Animal Welfare Act insofar as it applies to the research project, and that the research project is consistent with the Guide unless acceptable justification for a departure is present. Further the IACUC shall determine that the research project conforms with the institution's Assurance…

slide11

3. The IACUC shall conduct continuing review of activities covered by this Policy at appropriate intervals as determined by the IACUC…

4. The IACUC may suspend an activity that is previously approved if it determines that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the Guide, the institution’s Assurance…

the guide

1. …IACUC, also referred to as “the committee,” to oversee and evaluate the institution’s animal program, procedures, and facilities to ensure that they are consistent with the recommendations in this Guide…

2. Its (the IACUC) functions includeinspection of facilities; evaluation of programs and animal-activity areas; submission of reports to responsible institutional officials; review of proposed uses of animals in research, testing, or education (i.e., protocols); and establishment of a mechanism forreceipt and review of concerns involving the care and use of animals at the institution.

The ‘Guide’

slide13

3. Performance standards define an outcome in detail and provide criteria for assessing that outcome, but do not limit the methods by which to achieve that outcome. This performance approach requires professional input and judgment to achieve outcome goals.

4. ...the IACUC should pay particular attention to animal well-being through continuing evaluation of outcomes.

slide14

5. Assessment of animal space needs should be a continuing process.

6. A continuing and thorough assessment of surgical outcomes should be performed to ensure appropriate procedures are followed… In the event of modification, assessment of outcomes should be even more intense and might have to incorporate criteria other than the obvious clinical morbidity and mortality.

slide15

U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

VIII. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training…

who will be involved

Who will be involved?

  • Quality Assurance and Training Staff
  • ACUC Staff/Committee
  • Animal Health Technicians/Veterinarians
  • PI’s and Lab/Research Staff
  • Note: all CCM staff will report directly to the ACUC for all matters concerning PAM
who will be selected

Who will be selected?

  • All active protocols
  • Random selection
  • At the discretion of the ACUC and veterinary staff
  • Complimentary to ACUC semi-annual inspections
  • Initial Goal: one inspection per week
upon selection

Upon Selection…

  • Know the lab and the protocols
  • Labs will be contacted and visits scheduled
  • Compliance Liaison (CL) team visit
  • Document findings
  • Discuss findings with PI and research staff
examples of areas that will be reviewed

Examples of Areas that will be Reviewed

  • Protocol and Personnel
  • Study Procedures
  • Anesthesia
  • Surgery
  • Post-Surgical Care
  • Euthanasia
  • Record Keeping
  • Laboratory
after cl team visit

After CL Team visit

  • Written draft of visit to PI/research personnel
  • Final report: PI, research personnel, ACUC, Attending Veterinarian
  • Files of reports maintained by CLA
  • Follow up and support:
  • - Training
  • - Protocol modifications if needed
implementation

Implementation

  • Tentative plan to begin PAM program in January 2006
  • Initial plan to visit one lab per week
  • Much of it will be established as the program progresses
  • Changes will be made as necessary