Once your study has received all required approvals and is ready for activation, Step 3 focuses on the activities needed to successfully conduct, manage, and oversee your research in compliance with institutional, federal, and sponsor requirements. This phase includes tools and guidance to help you implement your protocol, maintain accurate documentation, protect participant safety, and ensure ongoing regulatory adherence throughout the life of your study.
These resources are intended as a starting point and are not comprehensive. Investigators are encouraged to explore the linked pages and institutional sites for additional tools, training, and guidance tailored to their research needs.
All resource titles appear as blue links and include a brief description and access information (if applicable). Click an accordion below to explore available tools and resources
– Supports study conduct through subject enrollment, visit tracking, financials, protocol calendars, and milestone management. – Integrates with VCU systems to ensure accuracy and reduce administrative burden. – Provides dashboards and reports to monitor study progress and compliance.
This resource provides downloadable templates to support compliant study conduct, documentation, and oversight throughout the active phase of a research study. These logs help study teams maintain accurate, consistent records aligned with GCP, IRB expectations, and sponsor requirements.
Templates available on the page include:
• Delegation of Authority Log – Documents study team roles, responsibilities, and effective dates – Tracks task assignments (e.g., consenting, AE reporting, data entry) When this is needed: At study start-up and whenever staff roles change
• Training Log – Records completion of required study-specific and institutional training – Supports compliance for audits and monitoring visits When this is needed: During study start-up and continuously throughout conduct
• Concomitant Medication Log – Tracks participant medications outside the study intervention – Helps identify potential interactions or protocol-relevant changes When this is needed: At each participant visit where medication history is collected
• Adverse Event Log – Documents reported adverse events and supports safety reporting – Helps reconcile source documents, safety submissions, and IRB reports When this is needed: Throughout the entire study for any participant-reported or observed events
• Monitoring Visit Log – Records details of monitoring visits, findings, and required follow-up – Supports study oversight and readiness for audits When this is needed: For every monitor visit (remote or onsite)
• Investigational Product Accountability Logs – Pharmacy to Site Log: Tracks IP released from pharmacy to study team – Site to Participant Log: Tracks IP dispensed to participants and returns When this is needed: For any study involving investigational product handling or dispensing
This resource supports compliant participant payments during study conduct by offering a secure, reloadable prepaid card system. It streamlines payment distribution, reduces administrative burden, and aligns with institutional financial controls. Study teams can use the program to issue stipends, reimbursements, and incentive payments while maintaining appropriate tracking and documentation. Guidance, forms, and required training are centralized to ensure correct setup and compliant ongoing use.
Getting Started
All individuals who will participate in administering the research prepaid card program must complete the Prepaid Card Program training in Canvas and successfully pass the associated quiz before project approval can be granted.
Next, complete the Prepaid Card Program PowerForm, which includes: – Entering project and study information – Identifying all department personnel responsible for administering or managing the program
After submission, the PowerForm will be reviewed and approved by the Principal Investigator, OVPRI, and Treasury Services. Once approvals are complete, participants may be registered and payments may be issued through the prepaid card system.
Forms and Materials Available on the Page
– Research Prepaid Card Program PowerForm – Detailed instructions for setting up and managing prepaid cards – Administrative guidance for registering participants and issuing payments – Program policy and compliance requirements – Canvas training link for required course and quiz
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
- Serious and unexpected adverse events (drugs/biologics): report to FDA within 7 calendar days; all others within 15 days - Device-related unanticipated events must be reported to FDA and IRB within 10 working days - Requires timely follow-up reports for additional information - Supports both IRB and FDA submission processes - Templates include FDA Form 3500A (plus Form 1571 for INDs) - Contact: VCU Regulatory Affairs Office (indide@vcu.edu) for guidance and submission support
This resource provides step-by-step guidance on VCU’s monitoring program for human subjects research. It explains the purpose of monitoring, how studies are selected, and what investigators should expect before, during, and after a monitoring visit. The page outlines available monitoring services—including routine, random, for-cause, and remote reviews—and provides documentation to help study teams maintain compliance with institutional and federal standards.
Key features include: – Overview of monitoring visit types (routine, random, for-cause, remote) – Monitoring scope: source document review, consent process verification, protocol adherence assessment, and regulatory documentation checks – Expectations for study team preparation and communication – Guidance on addressing findings, developing CAPA plans, and documenting follow-up – Information on scheduling monitoring visits and requesting assistance – Contact information for the VCU Regulatory Affairs/Clinical Research Monitoring team
Templates and documents available on the page include: – Monitoring Plan templates – Study Visit Log templates – Enrollment and Screening Log templates – Delegation of Authority Log templates – Regulatory Binder checklists – Sample Corrective and Preventive Action (CAPA) templates – Monitoring Follow-Up Report templates – Visit Notification and Close-Out templates – Tools for documenting protocol deviations and data issues
VCU login may be required for certain templates or documents.
How to access / whom to contact:
To request routine monitoring or “for cause” monitoring: contact indide@vcu.edu
For one-time monitoring visits: contact regaffairs@vcu.edu
This resource connects researchers with tools and support to recruit and retain participants, engage communities, and build collaborations — whether you’re launching a new study or maintaining ongoing recruitment.
What you’ll find on the page:
Access to volunteer-matching platforms (e.g., a national volunteer registry) to list your study and connect with interested participants.
A central study listings tool for VCU clinical trials and research studies open for enrollment.
Guidance and support for social-media and digital outreach (including posting IRB-approved ads on VCU Clinical Trials social media, and internal campus communication channels for staff/student reach).
Access to consultation services for tailored recruitment strategy support (e.g., help with outreach planning, community engagement, recruitment feasibility, or inclusive recruitment strategies).
Tools for population/cohort discovery and feasibility assessment via institutional or network-based data platforms (when available) to support protocol development and recruitment planning.
Resources for community engagement and partnerships, including potential collaboration with community advisory boards or community organizations.
When this resource is needed:
– When implementing recruitment activities after IRB approval.
– When executing your recruitment plan to begin enrolling participants.
– When promoting the study using IRB-approved materials and communication channels.
– When identifying and reaching eligible participants during active enrollment.
– When enrollment is slower than projected and new or adapted strategies are needed.
– When monitoring recruitment progress and adjusting outreach approaches.
– When engaging community partners to support ongoing recruitment and retention.
– When maintaining communication with participants and communities to support continued engagement throughout the study.
This resource provides support for engaging community members, organizations, and stakeholders throughout the active conduct of a study. It helps investigators strengthen trust, build relationships, and maintain communication with communities that contribute to and are affected by research. Study teams can access consultation, partnership-building resources, and engagement strategies designed to enhance participant retention, improve cultural relevance, and support ethical and inclusive research practices.
What you’ll find on the page: – Guidance on developing and maintaining community partnerships during study conduct – Support for community-engaged research approaches and culturally responsive engagement – Opportunities to collaborate with community organizations, advisory boards, and lived-experience partners – Tools to enhance communication with community stakeholders throughout the study – Assistance with planning engagement activities that promote retention, build trust, and increase study relevance – Consultation services for community-engaged research design, implementation, and ongoing study coordination
When this resource is needed (Conduct Phase):
– When sustaining community partnerships formed during study start-up or planning – When engaging community members to support ongoing recruitment or retention – When addressing barriers to participation and ensuring cultural responsiveness – When communicating study progress, updates, or changes to community partners – When building trust with underrepresented or historically marginalized communities – When incorporating community feedback to support study operations and participant experience – Throughout study conduct to maintain strong, ethical, and transparent community relationships
Provides guidance, tools, and frameworks to support collaborative research with community partners. Includes best practices, engagement models, partnership development resources, and tools that help study teams ensure their work reflects community priorities and enhances participation during the conduct phase.
When this resource is needed: – When working with community partners during study implementation – When adapting study procedures to better align with community needs – When ensuring ethical and equitable engagement with participant groups – When designing community-responsive communication or dissemination plans – When strengthening long-term relationships with communities involved in the study
This resource provides role-specific training and continuing education to support study teams during the active conduct of clinical research. It offers workshops, webinars, and certificate programs focused on Good Clinical Practice (GCP), regulatory compliance, participant recruitment, data quality, and day-to-day trial operations. Study teams can access structured learning pathways, competency-based training, and skill-building opportunities that strengthen protocol compliance and operational readiness. A centralized system allows individuals and supervisors to track completed courses and ensure all team members remain up-to-date with required training.
When this resource is needed: – When onboarding new staff who join the project during the conduct phase – When ensuring study team members maintain compliance with ongoing GCP or role-specific training requirements – When roles or responsibilities change and additional training becomes necessary – When preparing for audits, monitoring visits, or quality assessments – When study teams need support improving recruitment, data quality, or regulatory compliance – When enhancing professional skills that support efficient and compliant study operations
This resource provides access to institution-supported training required for conducting human subjects research at VCU, as well as optional educational opportunities that enhance research compliance and study conduct. It brings together core trainings in human subjects protection, responsible conduct of research, and research administration to support study teams throughout the lifecycle of a project.
What you’ll find on the page:
Required human subjects protection training for investigators and research staff
Responsible Conduct of Research (RCR) training opportunities
Guidance on training expectations for roles involved in clinical and human subjects research
Additional workshops and learning opportunities related to research ethics, compliance, and administrative processes
Links to platforms and modules where required trainings are completed (e.g., institutional learning systems)
When this resource is needed (Conduct Phase): – When ensuring all study staff maintain current training required to conduct human subjects research – When onboarding new team members during study conduct – When training needs emerge due to protocol amendments, new procedures, or added responsibilities – When preparing for monitoring visits, audits, or inspections requiring proof of training compliance – When study teams need ongoing education in ethical conduct, data handling, or compliant study management – Throughout study conduct to maintain readiness, compliance, and documentation of staff qualifications
