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U.S. Department of Health and Human Services

Training and Continuing Education

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ORAU Course Catalog 2013 - BIORESEARCH

 

Course ID: BR201
Course Title: Basic Clinical Bioresearch Monitoring
 
Course Description: This six (6) day course is designed to provide an overview of the Clinical Bioresearch Monitoring program and to provide practical training in the methods and techniques used in conducting and reporting Clinical Investigator, Institutional Review Board (IRB), Sponsor/Monitor/CRO and In Vivo Bioequivalence inspections. The course will consist of lectures, case study presentations, workshops and 483 exercises that cover the requirements of 21 CFR 50, 54, 56, 312, 812, and 511 as they relate to regulated research.
 
Course Objectives:
Upon completion of this course, the participant should be able to:
  1. Identify and utilize the proper Clinical Bioresearch Monitoring regulations, policies and procedures necessary to conduct the various types of Clinical Bioresearch Monitoring inspections.
  2. Identify strategies and approaches used to conduct various types of Clinical Bioresearch Monitoring inspections.
  3. Recognize and evaluate study data generated during a clinical trial for different types of Bioresearch Monitoring inspections.
 
Target Audience: Investigators, Supervisory Investigators, Compliance Officers, and CSOs from the centers who have limited experience in the BIMO program and who will conduct inspections or review EIRs of Clinical Investigators (CIs), Institutional Review Boards (IRB), Sponsors, Monitors, Contract Research Organizations (CROs) and In Vivo Bioequivalence inspections.
 
Prerequisites: Prior to attending, nominees must
  1. Completed their ORA New Hire training curriculum (FDA: Level I, including the audit) or completed the six (6) month district training program (includes 3 week ORA New Hire training curriculum) if hired prior to January 1, 2002 and not Level I; State employees should have completed their new hire program and have experience working in the program area.
  2. An active TURBO EIR account and have written a 483 in TURBO.
  3. Participated in at least one (1) Clinical Bioresearch Monitoring inspection prior to attending the course.
  4. Completed all pre-course reading (will be provided to enrolled participants prior to course).
 
Course Duration: 6 Days
CEU: 4.2
 
Course ID: BR202
Course Title: Basic Nonclinical Bioresearch Monitoring
 
Course Description: This 9½ day course is designed to provide an overview of the Good Laboratory Practices (GLP) regulations program area and types of studies. It will focus on practical training in the methods and techniques used in preparing, conducting and reporting Nonclinical Bioresearch Monitoring (GLP) inspections. This course consists of lectures, laboratory tours, laboratory demonstrations, a mock inspection and a workshop with presentations that will cover the requirements of the Good Laboratory Practice (GLP) regulations, , practical computer exercise, and a case study review.  
 
Course Objectives:
Upon completion of this course, the participant will be able to:
    1. Apply FDA regulations, policies and procedures to nonclinical laboratory and data audit inspections.
    2. Evaluate study data generated during a nonclinical laboratory inspection.
    3. Relate the principles presented during lectures, exercises and demonstrations to conduct inspections of nonclinical laboratories and perform data audits to determine adherence to the procedural requirements of the regulations.
    4. Construct FDA 483s that are based on regulations.
    5. Recognize and use the language and technical terms used in toxicological studies.
 
Target Audience:  This course is designed for Investigators, Supervisory Investigators, Compliance Officers, and CSOs from the centers who have limited experience in the BIMO program and who will conduct inspections or review EIRs of Clinical Investigators (CIs), Institutional Review Boards (IRB), Sponsors, Monitors, Contract Research Organizations (CROs) and In Vivo Bioequivalence inspections.
 
Prerequisites: Prior to attending, nominees must:
  1. Completed their ORA New Hire training curriculum (FDA: Level I, including the audit) or completed the six (6) month district training program (includes 3 week ORA New Hire training curriculum) if hired prior to January 1, 2002 and not Level I; State employees should have completed their new hire program and have experience working in the program area.
  2. An active TURBO EIR account and have written a 483 in TURBO.
  3. Participated in at least one (1) Non Clinical Bioresearch Monitoring inspection prior to attending the course.
  4. Supervisory Investigators, Compliance Officers and Center Consumer Safety Officers must have reviewed or participated in at least one (1) Non Clinical Bioresearch Monitoring inspection.
  5. Completed all pre-course reading (will be provided to enrolled participants prior to course).
 
Course Duration: 9.5 Days
CEU: Pending
 
Course ID:         BR250
Course Title:    Nonclinical Bioresearch Monitoring
(Note; BR202 & BR302 have been consolidated, those students who completed both courses BR202 and BR302 do not need to take this course)
 
Course Description:  This 9 ½ day course is designed to provide an overview of the Good Laboratory Practices (GLP) regulations program area and types of studies. It will focus on practical training in the methods and techniques used in preparing, conducting, and reporting Non- Clinical Bioresearch Monitoring (GLP) inspections. This course consists of lectures, laboratory tours, laboratory demonstrations, a mock inspection and a workshop with presentations that will cover the requirements of the Good Laboratory Practice (GLP) regulations, practical computer exercise, and a case study.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
 
  1. Apply FDA regulations, policies and procedures to non-clinical laboratory and data audit inspections.
  2. Evaluate study data generated during a non-clinical laboratory inspection.
  3. Relate the principles presented during lectures, exercises and demonstrations to conduct inspections of non-clinical laboratories and perform data audits to determine adherence to the procedural requirements of the regulations.
  4. Construct FDA-483s that are based on the regulations.
  5. Recognize and use the language and technical terms used in toxicological studies.
 
Target Audience:  CSOs, Compliance Officers, and Supervisory CSOs who will conduct, participate, or review establishment inspections/reports of non-clinical bioresearch laboratories.
 
Prerequisites:  Prior to attending, nominees must have:
 
  1. Completed their ORA New Hire training curriculum (FDA: Level I, including the audit) or completed the six (6) month district training program (includes 3 week ORA New Hire training curriculum) if hired prior to January 1, 2002 and not level I; State employees should have completed their new hire program and have experience working in the program area.
  2. An active TURBO account and have written a FDA 483 in TURBO.
  3. Participated in at least one (1) non- clinical bioresearch monitoring inspection prior to attending the course.
  4. Supervisory Investigator’s, Compliance Officers and Center Consumer Safety Officers must have reviewed or participated in at least one (1) non-clinical bioresearch monitoring inspection.
  5. Completed all pre-course reading (will be provided to enrolled participants prior to the course).  
 
Course Duration: 9.5 Days                                               CEU:  6.4
 

Course ID: BR301
Course Title: Advanced Clinical Bioresearch Monitoring
 

Course Description: This 3 day course is designed to provide practical training on emerging issues, new technology in electronic health records, patient diaries, and international clinical trials. The course consists of lectures, presentations, and a case study.

 
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Apply concepts presented during the course to conduct complex bioresearch monitoring inspections for adherence to the federal regulations.
  2. Identify and document complex FDA 483 observations.
  3. Identify and document falsified study data
 
Target Audience: This course is designed for Consumer Safety Officers, Supervisory Consumer Safety Officers, Compliance Officers or Center Consume Safety Officers with experience in conducting and/or reviewing clinical bioresearch monitoring establishment inspections and reports.
 
Prerequisites:  Prior to attending, nominees must:
  1. Completed their New Hire training curriculum (FDA: Level I, including the audit) or completed the 6 month district training program (includes 3 week new hire program) if hired prior to Jan 1, 2002 and not Level I; State employees should have completed their new hire program and have experience working in the program area.
  2. An active TURBO EIR account and have written a 483 in TURBO.
  3. Successfully completed the Basic Clinical Bioresearch Monitoring (BR201) course.
  4. Experience as a Consumer Safety Officer, Supervisory Consumer Safety Officer, and Compliance Officer and currently conducting/reviewing clinical bioresearch monitoring inspections. Experienced means participants have successfully conducted at least five (5) BIMO inspections per year after taking the Basic Clinical Bioresearch Monitoring (BR201) course.  
 
Course Duration: 3 Days
CEU: 2.1
 
Course ID: BR302
Course Title: Advanced Nonclinical Bioresearch Monitoring
 
Course Description: This course is designed to provide practical training in the methods and techniques used to audit necropsy and histology data, quantitative instrumentation, laboratory and electronic data management systems and environmental systems found in Nonclinical Laboratory (GLP) Bioresearch Monitoring inspections. This course will consist of lectures, a practical laboratory exercise, demonstrations, panel discussions and a computer exercise using EXCEL to audit study data.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Relate the principles presented during lectures, exercises and demonstrations to conduct complex nonclinical laboratory inspections.
  2. Recognize vulnerabilities of computerized systems used to collect or manage nonclinical laboratory data.
  3. Use computer program to effectively and efficiently audit nonclinical laboratory data.
 
Target Audience: Field Investigators, Supervisory Investigators, Compliance officers or Center Consumer Safety Officers with experience in conducting or reviewing nonclinical laboratory/GLP inspections or reports.
 
Prerequisites: Prior to attending, nominees must:
  1. Complete the ORA New Hire training curriculum: FDA, Level I; State employees must have completed their new hire program and have experience working in the program area.
  2. Be identified by management to conduct Nonclinical Bioresearch Monitoring (GLP) Inspections.
  3. Successfully complete the Basic Nonclinical Bioresearch Monitoring (BR202) training course.
  4. Will conduct these types of inspections upon completion of the course.
 
Course Duration: 4.5 Days
CEU: 3.3