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Clinical Trial Protocol Template: Key Sections for FIH Devices

Written by

Julio Martinez-Clark

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A solid clinical trial protocol template is the foundation of every first-in-human (FIH) study. Get it right, and your Ethics Committee submission, regulatory dossier, and site activation all move in sequence. Get it wrong, and you face amendment cycles that burn weeks you cannot recover.

This article walks through every section a FIH medical device protocol must contain, explains why each section exists from a regulatory standpoint, and flags the decisions that most often stall approval at MINSA/CNBI (Panama), ISP/MINSAL (Chile), SRS/CNEIS (El Salvador), and other Latin American regulatory authorities.

Why the Clinical Trial Protocol Template Matters for FIH Studies

A protocol is not a formality. Under ISO 14155 and FDA 21 CFR 812.28, it defines what data will be collected, how it will be collected, and why that data is sufficient to support a U.S. Investigational Device Exemption (IDE) or Investigational New Drug (IND) submission.

For a startup running its first FIH study, the protocol also functions as the single source of truth that aligns your FDA Pre-Sub strategy, your Ethics Committee (EC) submission, your principal investigator (PI) briefing, and your data management plan. A protocol written for one purpose and retrofitted for another creates gaps that reviewers find immediately.

The template structure below is organized in the order most Latin American regulatory authorities expect to see it, with notes on where FDA requirements add or modify those expectations.

Section 1: Title Page and Protocol Identification

The title page establishes the document's identity in the regulatory record. It must include:

  • Full study title and protocol number
  • Version number and date (version control is audited)
  • Sponsor name, address, and regulatory contact
  • Investigational device name and description
  • Coordinating investigator name and institution
  • Intended study countries and sites

Version control is not optional. Ethics committees in Panama and Chile routinely reject submissions that arrive with "v0.1" or undated drafts. Use a format such as "Protocol v1.0, [date]" and maintain a version history table on the following page.

The investigational device disclaimer belongs here as well. Standard language: "[Device name] is investigational; nothing here implies FDA clearance, approval, CE marking, or commercialization."

Section 2: Background and Rationale

This section answers one question for the reviewer: why does this study need to happen, and why now?

For FIH devices, the background must cover:

  • The clinical problem the device addresses
  • Current standard of care and its limitations
  • Summary of preclinical data (bench testing, animal studies, computational modeling)
  • Regulatory history, including any FDA Pre-Sub correspondence or IDE status
  • Justification for the proposed first-in-human dose, exposure, or implant parameters

Latin American ethics committees read this section carefully. They are not simply deferring to the FDA — they want to see that the sponsor has done the preclinical work and that the risk-benefit calculation is defensible in their jurisdiction. Sparse background sections are the single most common reason for EC requests for additional information.

Section 3: Study Objectives and Endpoints

State the primary objective in one sentence. Then define the primary endpoint with enough specificity that a data manager can build the case report form (CRF) from it without a follow-up question.

For FIH device studies, objectives typically fall into three categories:

  • Safety and feasibility: Assess the safety profile and procedural feasibility of the device in the target patient population
  • Performance: Evaluate device performance against a defined technical or clinical benchmark
  • Dose or exposure finding: Establish the safe operating range (relevant for energy-delivery devices, radiopharmaceuticals, or drug-device combinations)

Secondary endpoints follow the same specificity rule. Every endpoint you list will require a corresponding data collection instrument, a statistical analysis plan entry, and a follow-up visit that captures it. Endpoints that cannot be collected within the study's visit schedule should be removed before submission.

Section 4: Study Design

This section describes the architecture of the trial. For FIH studies, the design is almost always:

  • Single-arm, open-label, prospective
  • First-in-human or early feasibility study (EFS) designation
  • Single-center or small multi-center (2 to 5 sites for FIH)

Specify the design elements explicitly: number of subjects, enrollment sequence, follow-up duration, and whether the study includes a run-in phase or cohort expansion. If the design includes a stopping rule or a Data Safety Monitoring Board (DSMB) review at an interim point, describe it here.

The study design section is also where you document the regulatory framework. For studies intended to support U.S. IDE submissions, state explicitly that the study is conducted under ISO 14155 and structured per FDA 21 CFR 812.28. That language matters when FDA reviewers need to confirm the study was designed to their evidentiary standard.

Section 5: Subject Selection Criteria

Inclusion and exclusion criteria define the study population. For FIH devices, these criteria are more conservative than they will be in a pivotal trial. The goal is to enroll patients with the clearest possible risk profile so that any adverse events can be attributed to the device rather than confounded by comorbidities.

Write each criterion as a single, testable statement. Avoid compound criteria that combine two conditions with "and" — reviewers will ask which condition takes precedence if they conflict.

Common FIH inclusion criteria:

  • Age range (adults 18 and older, or a defined range for the target indication)
  • Confirmed diagnosis relevant to the device indication
  • Ability to provide written informed consent
  • Willingness to comply with the follow-up schedule

Common FIH exclusion criteria:

  • Pregnancy or breastfeeding
  • Active infection or immune compromise
  • Prior device implantation that could confound assessment
  • Contraindications specific to the device mechanism
  • Participation in another interventional study within a defined window

The exclusion criteria should be tight enough to protect subjects but not so restrictive that enrollment becomes impossible. Overly narrow criteria are a common cause of enrollment delays at sites in Panama and Colombia.

Section 6: Study Procedures and Visit Schedule

This is the operational core of the protocol. It describes what happens to each subject at each visit, in sequence.

Structure it as a visit schedule table followed by narrative descriptions of each visit. The table format makes it easy for site coordinators to build the study calendar and for ethics committees to confirm that follow-up is adequate for the risk profile.

For a typical FIH device study, the visit schedule includes:

  • Screening visit: Eligibility confirmation, informed consent, baseline assessments
  • Procedure visit: Device implantation or application, immediate post-procedure monitoring
  • Early follow-up visits: 24 hours, 7 days, 30 days (timing varies by device and indication)
  • Extended follow-up visits: 90 days, 6 months, 12 months
  • Early termination visit: Procedures for subjects who exit the study before completing all visits

Each visit description should specify who performs the assessment (PI, co-investigator, or study coordinator), what instruments or equipment are required, and what data is recorded in the CRF.

Section 7: Investigational Device Description and Accountability

This section describes the device in enough technical detail for the regulatory reviewer to understand what is being studied, without disclosing proprietary manufacturing information.

Required elements:

  • Device name, model, and intended use
  • Physical description and mechanism of action
  • Sterility and shelf life
  • Storage and handling requirements
  • Device accountability procedures (receipt, dispensing, return, and destruction)
  • Instructions for use (IFU) reference or attachment

Device accountability is audited at every GCP inspection. The protocol must specify how the site will track each unit from receipt to use or return. A device accountability log template is typically included as a protocol appendix.

For radiopharmaceutical studies involving compounds such as Lu-177, Ac-225, or Ga-68, this section expands to include radiopharmaceutical handling procedures, decay and disposal protocols, and radiation safety officer (RSO) requirements at each site.

Section 8: Concomitant Medications and Treatments

Define which concomitant medications are permitted, which are prohibited, and which require documentation without restriction. For device studies, this section is often shorter than in drug trials — but it is not optional.

Specify the washout period for prohibited medications and the documentation requirement for permitted ones. Ethics committees in Chile and El Salvador frequently flag protocols that omit this section entirely, treating the omission as evidence of incomplete study planning.

Section 9: Assessment of Safety

This is one of the most scrutinized sections in any FIH protocol. It must define:

  • How adverse events (AEs) are identified, graded, and reported
  • How serious adverse events (SAEs) are distinguished from non-serious AEs
  • Reporting timelines to the sponsor, EC, and regulatory authority
  • Device deficiency definitions and reporting requirements under ISO 14155
  • Stopping rules for individual subjects and for the study as a whole

Under ISO 14155, device deficiencies that could have led to a serious injury must be reported even if no injury occurred. This is a stricter standard than many sponsors expect from their drug-trial experience. Build the reporting workflow into the protocol itself, not just into the site's standard operating procedures.

Post-procedure safety monitoring is an area where digital tools have reduced the administrative burden on sites. Adverse event tracking platforms that support Individual Case Safety Report (ICSR) compliance and pharmacovigilance workflows — such as AE Connect at aeconnect.io — can help sites manage reporting obligations without creating bottlenecks in the data flow.

Section 10: Statistical Considerations

FIH studies are not powered for statistical significance in the traditional sense. Sample size is determined by safety and feasibility objectives, not by a power calculation against a primary efficacy endpoint.

The statistical section must still include:

  • Rationale for the planned sample size (typically 10 to 30 subjects for FIH)
  • Definition of the analysis populations (intent-to-treat, per-protocol, safety)
  • Descriptive statistics plan for safety and performance endpoints
  • Handling of missing data
  • Interim analysis plan, if applicable

FDA reviewers reading an IDE submission expect to see this section. A protocol that omits statistical considerations signals that the sponsor has not thought through how the data will be analyzed and reported.

Section 11: Data Management

This section describes how data flows from the site to the sponsor and ultimately into the submission-ready evidence package.

Key elements:

  • Electronic data capture (EDC) system or paper CRF specification
  • Data entry timelines and query resolution procedures
  • Source data verification (SDV) plan
  • Database lock and audit trail procedures

For studies intended to support U.S. IDE submissions, data must be structured per FDA 21 CFR 812.28. That means the data management plan needs to be designed with the submission package in mind from the start — not retrofitted after data collection is complete.

Section 12: Ethics and Regulatory Compliance

This section documents the regulatory and ethical framework governing the study. For multi-country studies in Latin America, it must address each jurisdiction separately.

Required elements:

  • ICH-GCP compliance statement
  • ISO 14155 compliance statement
  • List of regulatory authorities and ethics committees with jurisdiction over the study
  • Informed consent process and documentation requirements
  • Subject confidentiality and data protection procedures
  • Insurance and indemnification coverage (clinical-trial insurance policy)

For studies running in Panama, the relevant authority is MINSA/CNBI. In Chile, it is ISP/MINSAL. In El Salvador, it is SRS/CNEIS. Name each authority explicitly. Generic references to "local regulators" are not acceptable in a submission-ready protocol.

The informed consent section describes the process, not the document itself. The consent form is typically attached as a protocol appendix.

The section must specify:

  • Who obtains consent (PI or delegated qualified investigator)
  • When consent is obtained relative to any study procedures
  • Process for re-consent if the protocol is amended
  • Procedures for subjects who lack capacity to consent independently

Ethics committees in Latin America review the consent process as carefully as the consent document. Protocols that describe consent as a single event with no provision for questions or reconsideration are frequently flagged.

Section 14: Amendments and Deviations

Define the amendment process before the study starts. This section should specify:

  • What constitutes a substantial amendment requiring regulatory and EC re-approval
  • What constitutes a non-substantial amendment requiring notification only
  • How protocol deviations are documented, assessed, and reported
  • Corrective and preventive action (CAPA) procedures for recurring deviations

Amendment management is an area where single-team accountability pays dividends. When one team manages all nine workstreams from FDA strategy through data management, an amendment that affects the statistical analysis plan, the CRF, and the site monitoring plan can be coordinated without version conflicts across separate vendors.

Section 15: Publication and Data Sharing Policy

State the sponsor's policy on publication of study results, authorship, and data sharing. Most ethics committees require this section, as do some Latin American regulatory authorities.

For startup sponsors, this section also protects intellectual property. Specify the review period the sponsor retains before any publication is submitted, and define what constitutes confidential information that cannot be disclosed.

Putting the Template to Work in Latin America

A protocol structured under ISO 14155 and FDA 21 CFR 812.28 is the right starting point for submissions to MINSA/CNBI, ISP/MINSAL, and SRS/CNEIS. The regulatory frameworks are compatible, and ethics and regulatory approvals in Panama, El Salvador, Chile, and the Dominican Republic have been observed in 30 to 90 days when the protocol package is complete and well-structured on first submission.

That timeline matters for startup founders managing a 12 to 24 month runway to first human data. A protocol that requires two or three amendment cycles before approval can add months to a schedule that was already tight.

The Axoft FIH study in Panama is a concrete example of what a well-executed protocol and regulatory submission can produce: a first-in-human study that generated the clinical evidence supporting a $55M Series A. The Cook Group multi-site study in Colombia demonstrates the same discipline applied to a more complex multi-center design, with 142-plus INVIMA regulatory submissions managed across the program. The ClarVista Medical program shows how a rigorous FIH evidence package can support not just regulatory approval but a full acquisition by Alcon.

Protocol quality is not separate from business outcomes. It is the mechanism by which clinical evidence becomes investor-grade proof.

Frequently Asked Questions

What is a clinical trial protocol template for FIH devices?
A clinical trial protocol template for first-in-human (FIH) devices is a structured document framework that defines every section a FIH protocol must contain — from the title page and background rationale through subject selection, safety assessment, statistical considerations, and data management. It ensures the protocol meets ISO 14155 and FDA 21 CFR 812.28 requirements for U.S. IDE submissions.

How many sections does a FIH device protocol need?
A complete FIH device protocol typically contains 14 to 16 core sections, covering study identification, background and rationale, objectives and endpoints, study design, subject selection criteria, visit schedule, device description, safety assessment, statistical considerations, data management, ethics and regulatory compliance, informed consent, amendment procedures, and publication policy. Additional appendices cover the consent form, device accountability log, and CRF templates.

Does a protocol written for Latin American regulatory authorities satisfy FDA requirements?
Yes, when structured under ISO 14155 and FDA 21 CFR 812.28. Data collected under these standards in Latin American studies is accepted for U.S. IDE and IND submissions. The key is designing the protocol with the FDA submission package in mind from the start, not adapting it after data collection.

How long does ethics and regulatory approval take in Latin America for a FIH protocol submission?
In Panama, El Salvador, Chile, and the Dominican Republic, ethics and regulatory approvals have been observed in 30 to 90 days when the protocol package is complete on first submission. These are observed outcomes, not guaranteed minimums. Incomplete submissions or amendment cycles extend that window.

What is the most common reason a FIH protocol is rejected or sent back for revision?
Incomplete background and rationale sections, missing device accountability procedures, and sparse informed consent process descriptions are the most frequent causes of EC requests for additional information in Latin American jurisdictions. Protocols that omit statistical considerations or concomitant medication policies are also flagged regularly.

Can a single protocol template cover multiple Latin American countries?
A single protocol can cover multiple countries, but the ethics and regulatory compliance section must address each jurisdiction's specific regulatory authority by name. Generic references to "local regulators" are not accepted. For a multi-country study, the protocol should name MINSA/CNBI for Panama, ISP/MINSAL for Chile, SRS/CNEIS for El Salvador, and the relevant authority for each additional country.

Where can I get help developing a FIH protocol for a Latin American study?
bioaccess® manages protocol development as one of nine workstreams in its FIH-12 program, a 12-month engagement that delivers a submission-ready clinical evidence package. The FIH Launch Planner at bioaccessla.com generates a preliminary country route, timeline range, and evidence package estimate based on six questions about your program.

Conclusion

A clinical trial protocol template for FIH devices is not a fill-in-the-blank exercise. Each section carries regulatory weight, and the decisions made in the design phase determine how quickly your EC submission clears, how cleanly your data is collected, and how directly your evidence package supports an IDE or IND filing.

Build the protocol to the standard the submission requires. Name every regulatory authority explicitly. Design the data management plan for the FDA reviewer who will read it last. That discipline, applied consistently across all 15 sections, is what separates a protocol that clears in 30 to 90 days from one that spends that time in amendment cycles.

For a structured path from protocol development to submission-ready evidence package, visit bioaccessla.com.

Category: Navigating Regulatory Landscapes in Latin America

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