Step 2 guides you through the essential regulatory, operational, and institutional requirements needed to launch a compliant, well-prepared study. This phase focuses on obtaining required committee reviews, securing IRB approval, finalizing contracts and agreements, and developing the operational tools necessary to begin research activities.
The resources listed below are intended as a starting point and are not comprehensive. Investigators are encouraged to review the linked pages and institutional sites for additional policies, guidance, and training relevant to their specific study needs. If you have suggestions for additional resources, please email cctr@vcu.edu.
All resource titles appear as blue links and include a brief description and access information (when applicable). Click an accordion below to explore available tools and resources.
– PROC review is required for any study that uses VCU Health resources, including facilities, data, patients, or ancillary services. – The committee evaluates scientific merit, operational feasibility (such as patient population availability, staffing, and resource needs), and financial feasibility. – Applies to clinical research conducted at VCU Health; oncology-related studies follow the separate PRMC review process instead of PROC. – Investigators must submit to the correct PROC based on their clinical area. Submission should occur before IRB review. – Submission is completed through the OneTRAC system, which provides guidance, instructions, and required forms. – Key submission components include the study protocol, recruitment plan, estimates of eligible participants, staffing considerations, and resource needs. – Once reviewed, investigators receive PROC approval documentation, which is required for IRB submission. – PROC review ensures that proposed studies align with operational capacity, institutional priorities, and feasibility requirements.
Access instructions: Submit proposals through OneTRAC under the PROC submission section. For questions or help, contact PROC@vcuhealth.org
Human Research Protection & Regulatory Compliance
Obtain Needed Ancillary Committee Reviews (prior or concurrent with IRB submission)
These reviews are often triggered during IRB submission in VIRBS and must be completed before IRB approval - Conflict of Interest Committee – required when investigators/staff have significant financial interests in research outcomes - IACUC (Animal Care & Use) – needed for protocols involving vertebrate animals - Institutional Biosafety Committee (IBC) – required for studies using biohazardous agents, rDNA, or infectious materials - DURCIRE (Dual Use Research of Concern) – necessary when research could be misapplied for harmful purposes - Laboratory Safety Committee (LSC) – needed for protocols involving hazardous chemicals or lab activities - Radiation Safety Committee (RSC) – required when ionizing radiation is used beyond standard clinical care - IRB Reliance / External IRBs – included if study uses single IRB mechanisms
This page provides access to VCU’s HRPP Toolkit—a centralized library of documents supporting ethical and compliant human subjects research. Resources include policies, SOPs, templates, and guidance to help investigators prepare IRB submissions and meet institutional and federal requirements.
-The Investigator Manual (HRP-103) is available and provides detailed, policy-aligned guidance for VCU investigators on IRB submissions, reporting, and responsibilities. - General documents for IRB staff and investigators - Protocol and consent templates - IRB reliance forms and guidance - Worksheets for regulatory compliance - Checklists for IRB reviewers - Special guidance documents on: - Biological specimens - Certificates of confidentiality - Community-engaged research - Data security and management - Limited English Proficiency (LEP) participants - EFIC (Exception from Informed Consent) - Genetic research - GCP (Good Clinical Practice) - HIPAA - Internet-based research - IRB reliance - Recruitment and screening - Participant payment - Quality improvement vs. research - Secondary data/specimen use - Registries and repositories - Conflict of interest
VIRBS is VCU’s new centralized electronic system for IRB submissions and human research compliance – Streamlines preparation, submission, and tracking of IRB protocols and related activities – Replaces previous systems with updated workflows aligned to regulatory requirements – Facilitates initiation of new studies, amendments, continuing reviews, and correspondence tracking – Designed to improve efficiency and ensure timely IRB review and approval – Users should visit the VIRBS site for guidance, tutorials, and up-to-date information – The VIRBS page includes trainings, tutorials, and resources to help users navigate the system
Access instructions: Email erahelp@vcu.edu for access
This resource provides step-by-step guidance for submitting human subjects research protocols to the VCU Institutional Review Board (IRB). It outlines the requirements for new submissions, amendments, continuing reviews, and reportable events. The page includes links to templates, submission checklists, and training requirements to ensure compliance with federal regulations and institutional policies.
Key features include:
-Overview of IRB submission types and timelines -Required forms and templates -CITI training requirements -Access to RAMS-IRB submission portal -Contact information for IRB support staff
A reviewer‑focused checklist that outlines the required regulatory standards for IRB approval. Investigators can use it as a pre‑submission self‑check to ensure adherence to key criteria, including:
-Ethical research design that minimizes risk -Reasonable risk–benefit ratio -Equitable subject selection -Adequate monitoring, privacy, and confidentiality protections -Proper informed consent documentation -Additional safeguards for vulnerable populations -Provisions for data and safety monitoring, continuing review, and reporting
Using this worksheet can help investigators anticipate IRB expectations and improve the quality and compliance of their submissions.
IRB reliance enables VCU researchers to collaborate efficiently with external institutions by relying on a single IRB to oversee human subjects research—rather than requiring review at each site. This is especially useful for multi-site or industry-sponsored studies.
– Use IRB reliance when collaborating on non-exempt research with external institutions – VCU may serve as the reviewing IRB or rely on an external IRB, such as Advarra, WCG IRB, or a partner university – Faculty investigators remain responsible for submitting required documents in RAMS-IRB and following institutional/federal requirements – VCU HRPP does not allow reliance for exempt studies – Visit the HRPP page for detailed guidance, including: – When to Use IRB Reliance – Common External IRBs – VCU as Reviewing IRB – How to Request IRB Reliance – The site also includes training materials and step-by-step instructions to support the reliance process
This resource provides comprehensive guidance for VCU investigators conducting FDA-regulated research involving investigational drugs (IND), biologics, and medical devices (IDE or NSR devices). It consolidates regulatory expectations, decision tools, submission instructions, and investigator responsibilities to support compliance throughout the study lifecycle.
Templates and resources available on the page: • IND submission template components • IDE submission template components • Financial Disclosure Form (FDA Form 3454/3455) • Safety reporting templates • Annual report templates for FDA-regulated studies • Tools to determine whether an IND or IDE is required • Guidance for IND/IDE amendments, safety reports, and required documentation
When this resource is needed: – When planning a study involving an investigational drug, biologic, or medical device – When determining whether IND or IDE submission is required – When preparing IND/IDE submissions, amendments, safety reports, or annual reports – When ensuring regulatory compliance before IRB submission – When preparing for monitoring visits, audits, or FDA inspections – When verifying investigator responsibilities for FDA-regulated studies
Occurs in parallel with IRB submission during study planning and startup Covers the activities leading up to the submission and acceptance of a research award
- Applies to sponsored research grants, including federal, foundation, and industry-funded awards - Provides guidance on proposal development, routing, budget creation, and internal approvals - Explains key responsibilities of principal investigators, departmental administrators, and central offices - Includes tools and templates to support timely and compliant proposal preparation - Outlines how to route proposals through VCU’s electronic systems, including RAMS-SPOT - Highlights institutional deadlines and policies to ensure successful submission to sponsors - Emphasizes compliance with federal, sponsor, and institutional requirements
Principal Investigator Responsibilities - Develop a complete and accurate proposal, including budget, justification, and supporting documents - Coordinate with departmental staff for internal routing and approvals - Ensure that all compliance items (e.g., COI, IRB submission, training) are initiated as needed - Review sponsor guidelines and submission requirements - Communicate with Sponsored Programs regarding special terms, subcontractors, or unusual project elements - Submit required materials to departmental and central offices in advance of deadlines
VCU Sponsored Programs Support - Reviews all submissions for compliance with sponsor and institutional requirements - Assists with budget review, Just-in-Time requests, and final proposal routing - Coordinates final submission to sponsor and communicates confirmation
Key Resources - Proposal routing checklist - Budget template (Excel) - Budget justification template (Word) - PI eligibility form - Subrecipient commitment form - Scope of work template - VCU biosketch template
- Applies to sponsored research grants, including federal, foundation, and industry-funded awards - Covers the process after a Notice of Award (NoA) is received from a sponsor - Describes steps to set up the award in VCU’s systems - Outlines required compliance verifications before spending can begin - Explains the role of the Department of Sponsored Programs (DSP) in reviewing and accepting award terms - Includes guidance on award modifications and budgetary approvals - Ensures alignment between project scope, regulatory approvals, and financial management - Links to post-award resources once the award is activated
Principal Investigator Responsibilities
- Review and understand the award terms and conditions - Submit any remaining documents requested by the sponsor (e.g., Just-in-Time materials) - Ensure all necessary compliance approvals (e.g., IRB, IACUC, COI disclosures) are in place - Coordinate with departmental staff to confirm personnel and budget setup - Attend project kickoff or award setup meetings if requested - Monitor RAMS-SPOT for award activation and account setup - Verify alignment between approved protocol and awarded scope of work - Ensure training completion (e.g., CITI, GCP) for study team
VCU Sponsored Programs Support - Reviews and negotiates award terms and conditions - Coordinates setup of project accounts in collaboration with VCU Grants and Contracts Accounting - Confirms all compliance approvals (IRB, IACUC, COI) are in place before account activation
Standard operating procedures (SOPs) provide comprehensive guidance on the processes and best practices for conducting clinical research within VCU and VCU Health. These SOPs establish a consistent institutional framework designed to ensure compliance, quality, and efficiency in research activities. Importantly, they serve as a foundational resource that individual departments and research units can build upon, adapting and expanding the procedures to meet the unique requirements and workflows of their specific research programs. This flexibility supports both institutional standards and the diverse needs of specialized research areas, promoting rigorous and ethical conduct throughout all stages of clinical research.
The Data and Information Management Council (DIMC) ensures the integrity of institutional data, supporting research and academic operations. It establishes governance policies for data stewardship, facilitates secure data management, and promotes the use of a centralized data dashboard for decision-making. DIMC provides tools and training for researchers to handle data securely, helping to mitigate risks and optimize data usage across VCU systems. These efforts streamline research processes by offering reliable, well-organized data resources.
Details how to use Google Drive for research data management. It highlights its features for organizing, storing, and sharing research data securely. The guide offers best practices for collaboration and ensures compliance with VCU's data policies. It also addresses permissions, version control, and integrations with other research tools, helping researchers effectively manage and share their data throughout the research lifecycle.
What can be found on the page (available templates) & when each is needed:
• Delegation of Authority Log – Used at study start-up to document study team roles and responsibilities – Needed when staff join, leave, or change responsibilities – Required for audits, monitoring visits, and regulatory inspections to verify delegation alignment with qualifications
• Training Log – Used during start-up and throughout the study to track completion of study-specific and required trainings – Needed when onboarding new staff or implementing protocol amendments – Required for demonstrating training compliance during audits or IRB review
• Concomitant Medication Log – Used during participant visits to document any non-study medications – Needed when assessing safety, potential drug interactions, or eligibility – Supports accurate adverse event attribution and regulatory reporting
• Adverse Event Log – Used throughout the study to document adverse events and follow-up actions – Needed prior to submitting safety reports, continuing reviews, or monitoring visits – Supports regulatory compliance for FDA- and IRB-reportable events
• Monitoring Visit Log – Used when sponsors/CROs conduct site visits (initiation, interim, closeout) – Needed to record visit dates, findings, action items, and resolution status – Provides documentation for audit readiness and sponsor oversight
• Investigational Product Accountability Log (Pharmacy → Site) – Used when investigational product is shipped from pharmacy to the site team – Needed to document receipt, storage, and chain of custody – Required for compliance with Good Clinical Practice and FDA inspections
• Investigational Product Accountability Log (Site → Participant) – Used during participant visits for tracking drug dispensation and returns – Needed to verify dosing compliance and manage discrepancies – Required during monitoring visits, audits, and closeout to ensure accurate IP reconciliation
-Provides secure data storage, management, and sharing solutions for research data at VCU -Supports compliance with institutional and federal data policies -Offers consultation and tools for data organization, backup, and protection throughout the study lifecycle -Appropriate during study setup and ongoing study conduct
SUBMISSION REQUIRED FOR ALL CLINICAL TRIALS ClinicalTrials.gov is a federally mandated registry and results database for clinical trials, required for most studies to ensure transparency and regulatory compliance. This resource provides essential tools and guidance to support registration, record management, results reporting, and compliance.
Resources available on this page include:-ClinicalTrials.gov assistance -Is My Study a Clinical Trial? -ClinicalTrials.gov Account Request (VCU) -New Study Record Assistance -Study Record Transfers -Updating Study Records -Results Reporting Assistance -Uploading Informed Consent Forms -Compliance Notice #17-003 -Compliance Notice #19-002
