Key policies, procedures and regulations

• Federal policies and laws/regulations
• AAALAC International Regulations and Resources, U.S.
• ACUP policies and guidelines  
• DAR standard operating procedures
• IACUC written policies and procedures

Education and training

Required for investigators

• AALAS Learning Library (mandatory prior to final approval of IACUC protocol)
• VCU occupational health and safety program for animal handlers
• Researcher workshop: Conducting animal research at VCU 

Supplemental

• Request for research specific hands-on training
• RAMS-ACUP (IACUC protocols and animal ordering guidance documents)
• Educational resources
• NIH: What investigators need to know about the use of animals

VCU regulatory and administrative oversight

Division of Animal Resources (DAR)
(804) 828-9837
dar@vcu.edu 

Mark Bates, Ph.D., DVM, DACLAM
Director, DAR and Attending Veterinarian

Institutional Animal Care and Use Committee (IACUC)/Animal Care and Use Program (ACUP)
(804) 828-6587
iacuc@vcu.edu 

Amy (Kuei-Lan) Chuang, M.S., RQAP-GLP, CPIA
Director, ACUP

Jolene Windle, Ph.D.
IACUC chair

Forms and submission procedures

• ACUP forms
• RAMS-ACUP (protocol submission and animal ordering)

For more information

Website: ACUP
Email: iacuc@vcu.edu
Reporting: Click here to report compliance problems or concerns

Key policies, procedures and regulations

• Biological safety
• Select agents information page

Education, training and guides

Required for investigators (VCU eID required to log in)

• BioRAFT home page
• BioRAFT course directory

VCU regulatory and administrative oversight

Institutional Biosafety Committee

Forms and submission procedures

• Forms

For more information

Safety and Risk Management website

Key policies, procedures and regulations

• VCU: ClinicalTrials.gov registration and results reporting
• DHHS: NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
• FDA: FDAAA Final Rule (42 CFR Part 11)

Education, training and guides

• ClinicalTrials.gov FAQ’s and resources
• ClinicalTrials.gov training materials
• Decision tool: Is my study a clinical trial?
• Final rule: how do I determine if my study is an applicable clinical trial?
  • Applicable clinical trial checklist

VCU regulatory and administrative oversight

Maureen Olmsted, Ph.D.
Research navigator
ClinicalTrials.gov administrator

Johanna Biamonte, CCRP
Massey Cancer Center
Clinical trials reporting specialist

Forms and submission procedures

• ClinicalTrials.gov PRS account request form
• ClinicalTrials.gov Protocol Registration and Results System (PRS)

For more information

• Wright Center for Clinical and Translational Research ClinicalTrials.gov Site

VCU regulatory and administrative oversight

• VCU Conflict of Interest Review Committee
• Research Integrity and Ethics (Conflict of Interest Program)

Forms and submission procedures

• Access AIRS
• To access AIRS outside of VCU: Click here for VCU's VPN

For more information

• airs@vcu.edu
• VCU conflicts of interest in research webpage

Key policies and procedures

Use of controlled substances in research

Regulations

• DEA diversion control division
• Code of Federal Regulations, 21 CFR 1300-END
• New DEA registration and renewal applications
• Virginia Board of Pharmacy regulations
• Virginia Board of Pharmacy registration application

Education and training

• Use of controlled substances in research manual
• Controlled substances in research Compass training (registrants and authorized users)

VCU regulatory and administrative oversight

You Lee H. Kim
Senior research compliance analyst
controlsub@vcu.edu

Forms, submission procedures and more information

OVPRI controlled substances

Key policies, procedures and regulations

• Research data ownership, retention, access and security
• NIH Data Sharing Policy
• Code of Virginia (Chapter 7, Public Records Act)
• Records management
• Computer and network resources use
• VCU Data Management System (DMS)

Education and training

Required for investigators

• At discretion of the school

Supplemental

• At discretion of the school

VCU regulatory and administrative oversight

Srirama Rao, Ph.D.
Vice President for Research and Innovation

Forms and submission procedures

None

For more information

• Innovation Gateway
• Office of the Vice President for Research and Innovation

Key policies and procedures

Export compliance and research security

Federal regulations

• Office of Foreign Assets Control (OFAC)
• International Trade in Arms Regulations (ITAR)
• Export Administration Regulations (EAR)

Education and training

Required for investigators

• CITI training

VCU regulatory and administrative oversight

Export Compliance Program
International Affairs Compliance Committee
Peter Landsman, Assistant director

Forms and submission procedures

• VCU international employee/visitor export control review form
• Visiting nonemployee scholar agreement
• Export control self-assessment guide
• Export control red flags
• Office of Procurement Services travel services
• Temporary Export Certification (TMP) form
• International travel checklist

For more information

Key policies, procedures and regulations

• Reporting sponsor-investigator Investigational New Drug Applications (IND) or Investigational Device Exemptions (IDE)
• FDA IND regulations
• FDA IDE regulations
• VCU-VCUH clinical research standard operating procedures

Education and training

• FDA training and continuing education
• FDA learning portal for students, academia and industry
• REdI clinical investigator training course
• CDERLearn
• CDRHLearn
• Regulatory guidance for academic research of drugs and devices (ReGARDD)
• Talent@VCU - “Investigational New Drug Application (IND) Sponsor and Investigator Training” or “Investigational Device Exemptions (IDEs) Sponsor and Investigator Training”

VCU regulatory and administrative oversight

Elizabeth B. Collins, M.A., CCRP 
FDA regulatory program manager 
(804) 828-0819
estoddert@vcu.edu

Forms and submission procedures

• VCU FDA submission portal
• VCU IND/IDE procedure handbook
• VCU certification of IND/IDE suitability form
• IND/IDE external to VCU (domestic facilities) multisite certification form
• Other IND/IDE VCU forms and checklists 

For more information

VCU faculty-held IND or IDE
Email: indide@vcuhealth.org

Key policies, procedures and regulations

Federal regulations:

• The privacy rule
• The security rule

Education and training

Required for investigators

• VCU/VCUHS HIPAA training program
• VCU Health notice of privacy practices

Supplemental

• HIPAA for researchers
• Research repositories, databases and the HIPAA privacy rule
• Data classification standard
• Data handling and storage standard
• Personnel security standard
• Clinical research and the HIPAA privacy rule

VCU regulatory and administrative oversight

• VCU Affiliated Covered Entity Privacy Board
• Jill McCormack, Vice President
  Chief Compliance and Privacy Officer
  VCU Health Compliance Services

Forms and submission procedures

Forms (no current electronic submission)

Key policies, procedures and regulations

• Conduct of human subject research
• Determining what constitutes human subjects research (see p.10)
• IRB written policies and procedures
• DHHS regulations
• FDA regulations
• State regulations (see p.23)

Education and training

Required for investigators

• CITI training (required prior to IRB submission)

Supplemental

• Policies and guidance
• Guidance documents for using RAMS-IRB
• IRB events

VCU regulatory and administrative oversight

Susan Robb, CRA, CHRC
Interim director
Human research protection program

Monika Markowitz, Ph.D.
Director
Research integrity and ethics

Forms and submission procedures

Forms

For more information

IRB
Email: orsp@vcu.edu
Reporting: click here to report compliance problems or concerns

Key policies, procedures and regulations

• VCU intellectual property policy

Education and training

Required for investigators

• At discretion of the school

Supplemental

• At discretion of the school

VCU regulatory and administrative oversight

Ivelina Metcheva, Ph.D., MBA
Senior executive director

Magdalena Morgan, Ph.D.
Assistant director

Forms and submission procedures

Invention disclosure form

For more information

Innovation Gateway

Key policies, procedures and regulations

• Sponsored programs proposals: definitions, solicitation, review, approval and submission
• Sponsored programs proposal submission deadlines
• Division of sponsored programs responsibilities
• Sponsored agreements and gifts
• Facilities and administrative cost recovery
• Minimum effort for principal investigators and key personnel on sponsored programs
• Cost sharing
• Limited submission opportunities
• Corporate research agreements
• Policies and regulations links:
  • Pre-award costs
  • 2 CFR 200 (uniform guidance)
    • Uniform administrative requirements
    • Cost principles
    • Audit requirements for federal awards

Education and training

Required for investigators

• Mandatory training for PIs and research administration staff: A sponsored project compliance training program to increase awareness of grant accounting standards and improve accountability.

Supplemental

• Find funding
• List of training opportunities

VCU regulatory and administrative oversight

Division of Sponsored Programs

Tina L. Cunningham
Associate vice president for sponsored programs

Andrea J. Publow
Director, Government/Non-profit support

Melanie Wiggins
Director, Industry and clinical trials

Forms and submission procedures

• Sponsored programs forms
• Electronic submission information

For more information

Division of Sponsored Programs

Key policies, procedures and regulations

• Radiation safety guide
  • Guidelines for training and/or experience for investigators
• Emergency procedures
• Applicable state and federal regulations

Education and training

Required for investigators

Radiation safety training

This on-line training is designed to provide personnel with a basic understanding of VCU/VCUHS radiation safety rules and regulations, and to comply with the Commonwealth of Virginia's radiation safety regulations. Completion of on-line training is required for all personnel who use or plan to use radionuclides at the university.

1. Log in to BioRaft
2. Select “Training”
3. Select “Course Directory”
4. Select “Radiation Safety Training”
5. Follow on screen instructions

VCU regulatory and administrative oversight

Radiation safety committee (RSC)

Forms and submission procedures

Radiation safety forms

For more information

Safety and Risk Management

Key policies, procedures and regulations

• FDA IND regulations
• VCU Health policy - intranet only
• VCU-VCUH clinical research standard operating procedures

Education and training

Required for investigators

• At discretion of the school

Supplemental

• At discretion of the school

VCU regulatory and administrative oversight

Mary Pak, Pharm.D.
Manager, VCU Medical Center Investigational Drug Service
Mary.Pak@vcuhealth.org

Forms and submission procedures

Request IDS services 

For more information

VCU Medical Center Investigational Drug Service
Email: investigational.drug@vcuhealth.org