PRACTICAL GUIDE | 2026
Assemble the core once. Layer the deltas.
By Julio G. Martinez-Clark
CEO, bioaccess®
Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.
| Suggested URL slug | latam-fih-submission-package-checklist |
|---|---|
| SEO title | The Universal LATAM FIH Submission Package: Document Checklist | 2026 Guide |
| Meta description | The six documents every LATAM regulator asks for in an FIH submission — plus the country add-ons like Colombia's procedure-risk matrix. A pre-submission checklist. |
| Suggested excerpt | Protocol, investigator's brochure, informed consent, CRF, insurance, preclinical testing: the universal core every Latin American regulator asks for, and the local deltas that sit on top of it. |
Sponsors ask us: “What paperwork is required to submit in each of the countries you are considering?” The answer surprises them. The universal LATAM FIH submission package is nearly the same everywhere. Learn the core once; the country differences are add-ons, not new packages. This checklist exists to prevent the most common filing stalls — the ones that come from assembling documents country by country instead of core-first.
- bioaccess® — a first-in-human (FIH) contract research organization (CRO) running early-stage clinical trials across Latin America.
- FIH (first-in-human) — the first clinical use of a device or drug in people — typically a small, closely monitored early-feasibility study.
- IB (investigator's brochure) — the compilation of everything known about the investigational product: preclinical data, prior human experience, and risks.
- ICF (informed consent form) — the document — and the process — through which a patient is informed about the trial and agrees to participate.
- CRF (case report form) — the structured instrument used to capture every data point for every patient, consistently, at every site.
- INVIMA — Colombia's national institute for food and drug surveillance — the country's medical device and clinical trial regulator.
What documents does every LATAM regulator ask for?
The core package, in every market: the study protocol, the investigator's brochure, the informed consent form, the case report form, the insurance policy, and the preclinical testing package. Six documents. Every regulator asks for them, and the differences between countries sit on top of this core — they do not replace it.
What goes into each document?
- Study protocol — the complete scientific and operational plan: objectives, design, population, procedures, endpoints, statistics, and safety provisions. Everything else in the package must match it.
- Investigator's brochure (IB) — everything known about the investigational product — preclinical data, any prior human experience, known and anticipated risks. This is the document the ethics committee reads most closely.
- Informed consent form (ICF) — what the patient is told and agrees to, written in language the local ethics committee will approve — not just translated, but adapted.
- Case report form (CRF) — how every data point will be captured, consistently, at every site. Lock it before site training; changes mid-study are expensive.
- Insurance policy — coverage for trial-related injury, in the specific form each market requires. The requirement is universal; the paperwork details are local.
- Preclinical testing — the evidence package supporting first use in humans. The standard is the burden-of-proof rule: regulators want proof the product will be safe in humans, not a fixed checklist — rationale can substitute for specific tests.
| Document | What it proves | The stall it prevents |
|---|---|---|
| Study protocol | The science and the plan are complete and coherent. | Version drift between documents. |
| Investigator's brochure | The product's risk profile is fully disclosed. | Ethics committee rounds of questions. |
| Informed consent form | Patients are properly informed, in locally approvable language. | Committee rejection of a translated-but-unadapted form. |
| Case report form | Data will be captured consistently at every site. | Mid-study CRF changes and dirty data. |
| Insurance policy | Trial-related injury is covered per local requirements. | Regulator hold for non-conforming coverage. |
| Preclinical testing | First human use is justified by evidence. | Sufficiency challenges at committee review. |
What changes from country to country?
Local add-ons — and they are genuinely minor next to the core. The clearest example is Colombia: INVIMA expects a risk analysis matrix, and here is the point sponsors ask us to confirm explicitly: the matrix relates to the procedure, not the product. It is an analysis of procedural risk, not a demand for design-verification evidence in the FDA sense. Know the delta; do not rebuild the core. Translations, legalizations, and market-specific forms complete the country layer.
The pre-submission checklist
- Freeze the protocol version before assembling anything else — every document must match it.
- Confirm the investigator's brochure reflects the current preclinical package.
- Draft the informed consent for the local ethics committee's expectations, not just from the template.
- Lock the case report form before site training.
- Verify the insurance policy meets each target market's specific requirements.
- Confirm the preclinical package tells one coherent safety story — the burden of proof is on the sponsor.
- Layer the country add-ons last: Colombia's procedure-risk matrix, translations, legalizations, local forms.
- Reconcile names, versions, and dates across all six documents before submission.
Frequently asked questions
Is the submission package really the same in every Latin American country?
The core is: protocol, investigator's brochure, informed consent, CRF, insurance policy, preclinical testing. Country differences are add-ons layered on that core — for example, Colombia's procedure-risk matrix.
What is Colombia's procedure-risk matrix?
A risk analysis INVIMA expects with the submission — and the confirmed point sponsors ask about: it relates to the procedure, not the product. It is not a demand for design-verification evidence in the FDA sense.
What stalls filings most often?
The preventable ones: an incomplete core package, version mismatches between the protocol, the brochure, and the consent form, and insurance paperwork that does not match local requirements. The checklist above exists to kill all three.
When should we start assembling the package?
Before country selection is final. The six-document core is country-independent, so early assembly shortens every downstream clock.
Do we need the full package before a CRO can quote the study?
A synopsis plus the schedule of events gets you an honest rough range; the full package gets you precision. Quoting from less than that is fiction.
Does the ethics committee want the same package as the regulator?
Substantially yes — and in fast markets both receive it in parallel. Assemble once, submit twice.
Assemble the core once — correctly
bioaccess® builds FIH submission packages for Latin America every week: the universal six-document core, reconciled and version-locked, with each market's add-ons layered on top. Bring us your protocol; we will tell you exactly what is missing.
Talk with bioaccess® about your Latin America FIH strategyTalk with bioaccess® about your Latin America FIH strategy
References
- Core package contents reflect bioaccess® submission practice and sponsor Q&A, 2021–2026 (all clients anonymized).
- Colombia procedure-risk matrix: confirmed as procedure-related, not product design-verification evidence.
- Related reading: “How to Navigate the INVIMA Clinical Trial Submission Process” (bioaccessla.com blog).
- General: confirm market-specific add-ons with qualified regulatory counsel before filing.
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