How to Start a Clinical Trial

10 Steps to Meet FDA Standards

Starting a clinical trial is a critical milestone in bringing new medical products to market. Whether you are developing a drug, device, or biologic, your trial must meet strict FDA requirements for safety, ethics, and data integrity. This guide outlines 10 essential steps to help sponsors and researchers navigate the startup process with confidence and compliance.

1. Protocol Development

Every clinical study begins with drafting a clinical trial protocol. The protocol serves as the blueprint for the trial and must meet scientific, ethical, and regulatory standards. Key elements include:

• Objectives
• Study design
• Statistical plan
• Safety monitoring

The protocol must:

• Ensure the study is scientifically valid and ethically sound
• Comply with Good Clinical Practice (GCP) guidelines from the International Council for Harmonisation (ICH)
• Meet regulatory requirements for investigational products including drugs, devices, and biologics
• Protect participants and ensure reliable data as required by agencies like the FDA

2. Site Assessment and Selection

Selecting the right sites and investigators is essential for conducting a successful and compliant clinical trial. This step ensures the study can be executed effectively while protecting participants and meeting regulatory expectations.

A site assessment confirms whether a site has:

• Access to the appropriate patient population
• Experienced and qualified investigators and staff
• Adequate facilities, equipment, and operational resources
• A history of meeting regulatory standards, GCP, and ALCOA principles (data that are Attributable, Legible, Contemporaneous, Original, and Accurate)

Selecting qualified investigators ensures:

• Adherence to protocol requirements and regulatory obligations
• Protection of participant safety and rights
• Ability to generate high-quality, credible data that meet FDA and GCP standards

3. Regulatory and Ethics Approval

Before patients can be enrolled, regulatory and ethics approvals are essential to ensure the study is ethical and compliant.

Key requirements include:

• Submission of the protocol and supporting documents to Institutional Review Boards (IRBs) or Ethics Committees (ECs)
• Independent review to protect the rights, safety, and welfare of participants, as required by 21 CFR 56

Regulatory submissions depend on the type of investigational product:

• Drugs and biologics: An Investigational New Drug (IND) application must be submitted to the FDA under 21 CFR 312
• Medical devices: An Investigational Device Exemption (IDE) may be required under 21 CFR 812

4. Clinical Trial Agreement (CTA)

The CTA defines the legal and operational relationship between the sponsor and the clinical site.

The CTA outlines:

• Responsibilities related to regulatory compliance and data reporting
• Budget and payment terms
• Indemnification and liability provisions
• Intellectual property rights

The CTA ensures:

• All parties are clear on their roles and obligations
• Data integrity and participant safety are protected throughout the study

5. Investigator Meeting and Site Initiation

The investigator meeting helps ensure all study team members are aligned and prepared to conduct the trial responsibly.

The meeting covers:

• Protocol details and study objectives
• Safety reporting requirements
• GCP principles to protect participants and ensure data quality

The Site Initiation Visit verifies that each site is ready to begin the study.

The visit confirms:

• All required documentation is complete and accurate
• Site staff are trained in the protocol, safety procedures, and data entry systems
• The site meets FDA expectations for compliance and readiness

6. Essential Document Collection

Before a site can be activated, essential regulatory documents must be collected and filed to demonstrate compliance and ensure inspection readiness.

Key documents include:

• Form 1572 (Statement of Investigator)
• Investigator curriculum vitae
• Medical licenses for investigators
• Laboratory certifications (such as CLIA or equivalent)

These documents:

• Comply with 21 CFR 312.53 (drugs) and 21 CFR 812.43 (devices)
• Support audit and inspection readiness

7. Trial Supply Management

Proper management of trial supplies is critical to ensure accountability and compliance.

Key activities include:

• Ordering, labeling, and shipping study drugs, devices, and/or laboratory kits to sites
• Establishing appropriate storage conditions and inventory controls
• Ensuring investigational products are handled according to FDA requirements for safety, traceability, and accountability

8. Database and Electronic Data Capture (EDC) Setup

An EDC system supports accurate and secure data collection.

This step involves:

• Programming the system to match the protocol requirements
• Creating data entry forms, automated edit checks, and user access roles
• Ensuring compliance with 21 CFR Part 11 for electronic records and signatures, protecting data integrity

9. Training and SOP Compliance

Comprehensive training ensures that all site staff are prepared to conduct the study properly.

Training covers:

• The protocol and its requirements
• Safety reporting procedures, including those under 21 CFR 312.32
• Use of the EDC system
• Sponsor-specific standard operating procedures

10. Site Activation

Once all startup steps are complete, the site is approved to begin patient enrollment.

Site activation confirms that:

• Essential documents are complete
• Supplies have been received and verified
• Systems have been validated
• Staff have been fully trained

The site is officially marked as ‘open to enrollment’ and ready to generate data that will support regulatory submissions.

Starting a clinical study requires thoughtful planning and strict adherence to regulatory requirements. Each step, from protocol development to site activation, is essential for protecting participants and ensuring data integrity. Meeting FDA standards helps support the approval of therapies that can improve and save lives.

At MED Institute, we specialize in helping sponsors navigate every phase of the clinical trial process. From protocol development to site activation, our team ensures your study meets FDA requirements efficiently and ethically. Contact us to discuss how we can support your next clinical trial 855.463.1633 | askmed@medinstitute.com.