Forms

• Sponsored programs
  • Pre-award
  • Award set-up
  • Post-award
  • Industry and clinical trials
  • Non-funded agreements
• Research administration and compliance
• Controlled substances forms
• VCU Innovation Gateway
• VCU IRB
• Western IRB
• ACUP

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Sponsored programs forms

Visit the VCU Controller website for current rate information.

Pre-award

Proposal forms

• F&A Exemption Request Form [Word version]
• Generic Proposal Face Page
• Grant Transfer Between Institutions Form (Incoming grant transfer)
• NSF Fastlane Account Request Form
• NIH eRA Commons Account Request Form
• Principal Investigator (PI) Eligibility Exception Form
• VCU Health System Employee Approval Form (Required for engagement in sponsored project activities)

Budget development

• Cost Sharing Authorization Form
• Detailed Budget Worksheet, 1-5 Year Project
• Loaded Budget Worksheet, 1-5 Year Project
• Modular Budget Worksheet, 1-5 Year Project
• Percent of Time and Effort to Person Months Conversion Table 
• New Sponsor Form
• RAMS-SPOT SF424 Detailed Subaward RR_Budget
• VCUHS Ancillary Services Request

Subrecipient(s)

• All Occasion Letter to Subrecipient when VCU is PTE
• Subrecipient Project-Specific Consortium Letter (when VCU is PTE)
• VCU Entity Form for non-FDP Expanded Clearinghouse Subrecipients
• VCU IDC Uniform Guidance Letter to Subrecipient

Resources and references

• All Occasion Letter to PTE when VCU is Subrecipient
• Intellectual Property Definitions
• VCU IDC Uniform Guidance Letter to Sponsor

Award set-up

• Administrator New Award Set-Up Checklist
• Banner Account Request Form

Post-award

Award acceptance, establishment and management

• Grant Transfer Between Institutions Form (Outgoing grant transfer)
• Grants and Contracts Accounting and Effort Reporting Forms

Industry and clinical trials

• Accelerated CDA Template
• Accelerated Clinical Trial Agreement (ACTA) Template
• ClinicalTrials.gov Account Create Form
• Industry Clinical Trial Internal Budget Template

Non-funded agreements

• Confidentiality/Non-Disclosure Agreement Request
• Data Use Agreement Request

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Research administration and compliance forms

• Clinical Research Coverage Analysis Forms
• Disposition of Research Data Form
• VCU International Employee/Visitor Pre-Screening Form
• Sponsored Project/Research Volunteer Documentation Form
• Visiting Nonemployee Scholar Agreement
• TMP Exception Form
• Subrecipient Interest Disclosure Form
• VCU Employee and Facility Use Guidelines for Clinical Research

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Controlled substances forms

• Checklist - Applying for Virginia Board of Pharmacy and DEA Registrations [Word version]
• Personnel Screening Form – Authorized User
• VCU Controlled Substances Inspection Form
• Authorized Users Signature Log I [Word version]
• Authorized Users Signature Log II-V [Word version]
• Controlled Substances Inventory Record [Word version]
• Controlled Substance Dispensing Record [Word version]
• Controlled Substance Usage Log [Word version]
• Controlled Substance Disposal Log [Word version]
• Controlled Substance Transfer Invoice [Word version]

To request a copy of a sample completed application or form, email controlsub@vcu.edu.

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VCU Innovation Gateway forms

• Invention Disclosure Form

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VCU IRB forms

VCU IRB forms are revised periodically. When preparing a submission, please be sure to use the most current versions of the forms by referring to this website and linking to the forms below. The IRB will accept the preceding version of the form for 30 days following the posting of a revised form.

IRB reliance forms

• Site Specific Application for Relying on VCU’s IRB (rev. 10/1/2018)
• VIRGINIA Site Specific Application for Relying on VCU’s IRB (rev. 10/1/2018)
• Relying Site Continuing Review Form (rev. 10/1/2018)
• Relying Site Closure Request Form (rev. 10/1/2018)

HIPAA forms

• Review Preparatory to Research Form
• HIPAA Data Use Agreement for Limited Data Sets
• Stand-alone HIPAA Authorization template (rev. 6/1/11)
• Verbal HIPAA Authorization Script template (rev. 1/21/19)
• Research on PHI of Decedents Certification Form

Visit our HRPP policies and guidance page to learn more about HIPAA guidance.

General consent and assent templates

These templates comply with the 2018 Final Rule Requirements for informed consent documents.

• Biomedical Consent Template (rev. 1/21/19)
• Social-Behavioral Consent Template (rev. 1/21/19)
• Child Assent Template (rev. 10/1/18)
• Exempt Study Information Sheet Template (rev. 1/21/19)
• Guidance for preparing forms and consents

Consent templates for specific types of studies

• Research Repository Consent Template (rev. 6/8/17)
• Consent Template for Humanitarian Use Device (HUD) (rev. 10/1/18) - To be used in conjunction with HUD patient labeling

Consent short forms for non-English speaking subjects

To be used in conjunction with the full English language consent form

• Arabic Short Form
• English Translation of Short Form
• Farsi Short Form
• French Short Form
• Mandarin Short Form 
• Russian Short Form
• Somali Short Form
• Spanish Short Form
• Swahili Short Form
• Tsonga Short Form
• Vietnamese Short Form
• Venda Short Form

Supplemental submission forms

• Certificate of Confidentiality Assurance Letter Template (rev. 10/1/2018)
  For non-NIH funded studies that apply for a Certificate of Confidentiality - email completed, signed letter to IRBPanelA@vcu.edu for counter-signature by the Institutional Official
• Study Closure Form (rev. 5/14/14)
  PAPER STUDIES ONLY - email the completed and signed form to IRBPanelA@vcu.edu
• Principal Investigator Eligibility Form (rev. 10/1/2018)
  For non-employees of VCU/VCUHS who have a VCU faculty status.
• Appeal Form (rev. 10/1/2018)

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WIRB submission instructions and forms

What may be reviewed by WIRB?

All industry sponsored research involving human participants should be submitted in RAMS-IRB requesting review by WIRB , except projects that meet one or more of the following criteria:

• Funding provided by the Department of Defense directly to VCU or as a sub-award
• Involve human subject activities conducted by Navy and Marine Corps personnel
• Involve naval military personnel and Department of Navy (DoN) employees as research subjects
• Are supported by naval activities through any agreement (e.g., contract, grant cooperative agreement, development agreement [CRADSs], or other arrangement), regardless of the source of funding, funding appropriation, nature of support, performance site or security classification
• Are using DoN property, facilities or assets

How do I submit to WIRB?

Initial submissions

All new WIRB Submissions from VCU must first be submitted to the VCU IRB for institutional review and not directly to WIRB. All new WIRB protocols should be submitted through RAMS-IRB. Please review the following submission steps carefully:

1. OSP Red (Contracts) Injury Language Review: OSP reviews informed consent forms (ICF’s) for industry funded clinical trials to ensure compliance with subject injury language in contracts. An OSP Subject Injury Language Review Task List has been created in OnCore to track OSP subject injury language review and approval for submission to WIRB. 
   1. Prior to submitting a WIRB study in RAMS-IRB, the PI/Study staff reviews consent form for revisions to non-injury language and coordinates with their School/Department for the creation of a funding proposal in RAMS-SPOT for subsequent notification to OSP.
      1. School/Department reviews ICF, makes any changes related to costs, uploads latest ICF redline (as appropriate) to OnCore under Task Number 1 of the OSP Subject Injury Language Review Task List and records the date under “Completed Date”.
      2. School/Department creates a review record in RAMS-SPOT via the Submit Document for Review section, uploads the contract, links the funding proposal and logs a comment in the Funding Proposal stating that the consent form is available through OnCore for review.
      3. The Document Review should include Sponsor/CRO contact information for both the consent form and the contract for negotiation purposes.
      4. School/Department will access OnCore and record the “Completed Date” that contract was uploaded to SPOT under Task Number 2 of the OSP Subject Injury Language ReviewTask List.
   2. OnCore will generate a report to OSP Red indicating an ICF Subject Injury Language review is needed. OSP will access OnCore and record the “Completed Date” under Task Number 3 when the reviewer begins ICF review and will review and negotiate the appropriate revisions to the subject injury language directly with the Sponsor or contract research organization (CRO), as appropriate.
   3. Once OSP has completed negotiation of the language, they will upload an approval memo with the VCU/Sponsor approved ICF template to OnCore under Task Number 4 of the OSP Subject Injury Language Review Task List and record the “Completed Date”. OnCore will generate a report and send it to the school indicating: OSP Approval and Upload of Approved Injury Language ICF and Memo.
   4. Study Team/School (as appropriate) will access approval documents in OnCore under the OSP Subject Injury Language Review Task List and will mark the “Completed Date” under Task Number 5 of the Task List.
   Please contact ospred@vcu.edu with any questions.
2. Submit WIRB Submission through RAMS-IRB: Study teams should initiate a submission in RAMS-IRB and complete the smart form. When requested, select External IRB (WIRB) as the reviewing IRB. When the smart form is complete, submit the study.
   1. Documents that should be uploaded into the RAMS-IRB study workspace include:
      1. Study protocol
      2. Informed consent form(s)
      3. HIPAA Authorization(s) if separate from Informed Consent(s)
      4. Investigator Brochure
      5. PI Curriculum Vitae
      6. Memo from OSP indicating injury clause language in consent has been approved
3. The submission will be routed to the ORSP for a compliance review.
   1. The ORSP will:
      1. Request that a COI review be conducted
      2. Verify mandatory training completion (human subjects and GCP)
      3. Ensure the PI is appropriately credentialed and privileged to perform clinical work
      4. Confirm appropriate HIPAA PHI pathway
      5. Verify documentation of how payment will be made for WIRB review
      6. Ensure that the documentation of Injury Clause review and approval has been done
      7. Ensure compliance with VCU Policy "Reporting Sponsor-Investigator INDs or IDEs"
   2. Upon completion of the ORSP review, the PI will receive an email memo indicating the review is complete and the study may be submitted to WIRB.
4. The Study Team submits the study to WIRB
   1. The PI/Study Team is responsible for submitting all required documents to WIRB via the WIRB electronic submission system. In addition to all study related documents, the following documents must be included with the WIRB submission in order for a review to occur:
      1. ORSP memo indicating institutional review is complete
      2. Verification that injury clause language has been reviewed

Please contact OSPRed@vcu.edu if you have questions about ICF injury clause review. Please contact ORSP@vcu.edu for questions about WIRB submissions in RAMS-IRB.

Maintaining approval and ongoing submissions

1. Once the initial submission is approved, the Principal Investigator is responsible for directly submitting all future submissions to WIRB including:
   • Changes in research (amendments)
   • Unanticipated problems
   • Continuing reviews
   • Study closure

   A copy of ALL submissions should be provided to ORSP by performing a “Document Upload” in the study workspace in RAMS-IRB, as well as to WIRB.

2. RAMS-IRB will send a reminder to the PI/Study team around the expiration date of the study. The PI/Study Team is responsible for updating the expiration date based on the most recent continuing review completed by WIRB and providing a summary of progress. WIRB will send continuing review reminder notices to principal investigators. Please pay close attention to the reminders. WIRB strictly enforces deadlines.

WIRB submission forms

The most efficient way to submit to WIRB is directly through the WIRB electronic system called Connexus. If choosing to submit application documents via document upload, be sure to use the most recent forms obtained directly from the WIRB website.

VCU requires that specific informed consent template language be used. Be sure to use the template below when creating a consent form.

• External IRB Clinical Trial-VCU Consent Template (rev. 3/17/16)
• VCU-DNA Consent Addendum

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