Launching a clinical research site can feel like adding a new service line to an already full clinic schedule. Most first-time sites don’t struggle because clinicians lack medical expertise. They struggle because research adds a second set of rules: protocol guidelines, documentation rules, and oversight expectations that are unfamiliar until you have lived through a startup, a monitoring visit, or an audit.
At CITI Program, we built training like the Establishing a Clinical Research Program course because the early missteps are remarkably consistent and preventable when you approach research as a system, not as a side project.
Here’s what you need to know about launching your first site, including the common early mistakes that can delay activation, create compliance risk, or exhaust your team.
Why Add Clinical Research to Your Practice
Clinicians and healthcare institutions add clinical research for patient access to investigational therapies, clinical standardization that improves routine care, and professional growth through academic collaboration and enhanced community reputation.
Research is not simply “more clinic.” In FDA-regulated studies, investigators are responsible for conducting the investigation according to the investigational plan, protecting subjects, and maintaining control of investigational drugs, among other obligations. You can delegate tasks, but not responsibility.
That last point is where many first-time sites stumble. The benefits are real, but they only show up when the site is built to run compliant, repeatable research.
What to Know Before You Start
Before you sign your first confidentiality agreement or complete your first feasibility questionnaire, be prepared to answer four essential questions: What kind of research are you doing? What oversight applies? What will your documentation burden be? How will safety reporting work?
Know your regulatory lane
Some human subjects research is not FDA-regulated, but most clinical trials involving drugs, biologics, or devices are. That distinction matters because it determines sponsor expectations, monitoring intensity, documentation requirements, and inspection risk. Investigator responsibilities for FDA drug studies are spelled out in federal regulations, and they are not optional.
Treat GCP as your operating system, not a certificate
Good Clinical Practice (GCP) is the baseline ethical and scientific standard used across trials. It frames expectations for protocol compliance, documentation, safety oversight, and quality management. The updated ICH E6(R3) guideline emphasizes flexibility, risk-based approaches, and integration of digital technologies to support modern trial designs, including decentralized trials. Sponsors and Contract Research Organizations (CROs) will most often dictate that your team is working within this framework.
A common first-site mistake is thinking GCP is a one-time training event. In practice, it’s how you design workflows.
Human subjects protections are not a formality
The federal regulations at 45 CFR 46 outline IRB review requirements and additional safeguards for certain populations. Even when a sponsor provides templates, your site still needs an informed consent process that is consistent, documented, and respectful of participant understanding.
A predictable early pitfall is treating consent as paperwork done quickly to keep the participant onboarding moving along. Sponsors and oversight bodies see consent as a process, and they will review it that way.
Audit readiness starts on day one
Many clinicians only think about audits after something goes wrong. Regulators do not wait for you to feel ready.
FDA’s Bioresearch Monitoring (BIMO) program includes inspections and data audits designed to monitor the conduct and reporting of FDA-regulated research. That has a simple implication for new sites: build basic documentation discipline early. Your source documentation, delegation, training records, investigational product accountability, and protocol deviation tracking are not administrative details. They are how your site proves it is conducting compliant research.
Safety reporting needs a clear path, not good intentions
Adverse events (AEs) and serious adverse events (SAEs) can occur during clinical trials. The risk is not that you will never see an AE. The risk is that staff will not know what counts, who to inform, and how quickly to act.
Your site should translate regulatory expectations into something practical: a written escalation pathway that staff can follow without hesitation.
First Steps to Establish a Site
Think of your first site build as a “minimum viable system” that can scale. You do not need a research institute. You need a team, infrastructure, and financial clarity.
Step 1: Decide what kind of site you are building
Start with a narrow, realistic scope: one therapeutic area that matches your patient population, studies that fit your clinic flow, and a clear sense of visit complexity.
A frequent first-site mistake is saying “yes” to a protocol that looks exciting but does not fit your real-world operations.
Step 2: Build the minimum viable team
Study start-up remains a top challenge for sites, with 31% citing it as a primary concern in 2025. Much of this stems from unclear roles.
Many studies demand a Principal Investigator with oversight responsibility, a Clinical Research Coordinator for screening and visit logistics, regulatory support for essential documents and IRB submissions, and data support for query resolution and coverage planning.
A common avoidable error is “phantom delegation.” Tasks get done, but delegation logs are incomplete, training is undocumented, and the PI cannot demonstrate oversight. GCP expects clear roles and responsibilities.
Step 3: Build infrastructure before the first patient visit
Your early infrastructure should include core standard operating procedures (SOPs) for informed consent, AE escalation, protocol deviations, investigational product accountability, and document control. Keep workflows lean and focused on what generates findings when absent.
Essential tools include secure document storage, a tracking method for screening and enrollment (a clinical trial management system [CTMS] or structured spreadsheet), and consistent source documentation approaches. Modern trials increasingly support decentralized elements like telehealth visits and remote monitoring. Building flexible systems now positions you for future opportunities.
A classic pitfall is expecting that everything can be documented via email, only to discover you cannot reconstruct decisions or timelines under pressure.
Step 4: Understand funding and budgeting early
Many new sites start with sponsor-funded trials. Plan for startup costs, per-patient costs, staff time for screening and data cleanup, and contract negotiation timelines.
A failure mode is overpromising enrollment to win the study. Sponsors remember performance. A smaller, honest number you can deliver beats a big number that collapses under clinic reality.
Step 5: Build a recruitment and retention plan that respects ethics and workflow
Recruitment is not marketing. It must align with IRB requirements, privacy expectations, and institutional policies. Even if a sponsor provides materials, your site owns how screening happens and how you document eligibility.
A common early mistake is assuming clinic volume automatically translates to enrollment. Eligibility criteria, competing priorities, and visit intensity will cut that number quickly.
Collaborating with Sponsors, CROs, and Oversight Bodies
First-time sites often feel like the power dynamic is stacked against them. A more useful lens is this: sponsors, CROs, and oversight bodies want predictable execution and credible data. If you understand what they look for, you can build it into your site from the start.
Sponsors and CROs: what they expect from a new site
They assess feasibility accuracy, patient access, staff capacity and coverage, documentation readiness, and PI oversight. They expect you to work within GCP, maintaining documentation that allows reconstruction of what occurred and why.
Understanding monitoring visits
Monitoring visits often reveal gaps, including source documentation inconsistencies, missing training records, unresolved queries, uncaptured protocol deviations, and unclear AE pathways. Treat monitoring as structured feedback, not crisis management.
Oversight and inspection readiness
FDA’s BIMO program monitors FDA-regulated research through inspections and data audits. Document contemporaneously, control versions, track deviations, and keep delegation and training records current so your work can be evaluated by someone who was not in the room when decisions were made.
Training and Support Resources
Train your team before study activation, not after your first findings. Research requires consistent processes, documentation, and oversight behavior.
Use role-based training, including PI-focused training on responsibilities and oversight, CRC and staff training on GCP expectations and essential documents, and institutional training on human subjects protections and IRB processes.
CITI Program’s Establishing a Clinical Research Program course provides structured guidance on the early decisions, systems, and training foundations that support compliant, sustainable research for clinicians and institutions as they move from interest to operational readiness.
Building for Success, Not Perfection
You can build a successful first research site without the crushing weight of bureaucratic burdens. Accept that research is a regulated system, then build viable systems that match that reality.
Three things prevent most painful surprises: answer feasibility questionnaires honestly and choose protocols that fit your real workflow, build clean delegation and documentation habits from day one, and train your team in a shared framework so expectations are consistent across roles.
From there, research becomes less mysterious and more operational. That is when the benefits begin to compound.
References
1. General responsibilities of investigators, 21 CFR § 312.60 (2023).
2. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 2025. “Guideline for Good Clinical Practice E6(R3).” Accessed February 23, 2026.
3. Protection of Human Subjects, 45 CFR § 46 (2018).
4. U.S. Food and Drug Administration (FDA). 2025. “Bioresearch Monitoring Program Information.” Accessed February 23, 2026.
5. Association of Clinical Research Professionals. 2025. “Unveiling 2025’s Biggest Site Challenges: Data-Driven Insights to Optimize Site Success.” Accessed February 23, 2026.
6. U.S. Food and Drug Administration (FDA). 2024. “Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Interested Parties Availability.” Federal Register 89(181):76481-2.
