Most sponsors plan a Colombian device study down to the week until first patient in. Very few plan the last step: closing the study with INVIMA. The final visit is done, the sites are closed, the CRO contract has ended, and then a letter arrives saying INVIMA can’t close the file yet. It wants a corrected report, the full results analysis, and someone in Colombia to answer for the study.
I’m Julio Martinez-Clark, CEO of bioaccess®. We run first-in-human and early feasibility device studies in Latin America, and Colombia is one of our core countries. We are handling one of these right now. So here is how INVIMA’s device-study closure works, what the form asks for, and what to settle before the last site closes.
The short answer
For a clinical study with a medical device, INVIMA’s Dirección de Dispositivos Médicos y Otras Tecnologías takes periodic and closure reports on one form: ASS-RSA-FM170, “Formato para informes periódicos o de cierre de estudios clínicos” (version 01, issued 3 November 2023). The form says it must be filed while the study is running and up to its closure. It must cover every research site INVIMA approved, the data must be cumulative, and the ethics committee’s (CEI) notification and response letters for that report must be attached.
The closure version is the same form with its final section completed. That section asks for actual end-of-recruitment dates, actual end-of-visit dates, actual closure dates per site, whether a final data-analysis report exists (and to attach it), and whether goals, objectives and outcomes were met. A closure report without the final analysis attached is incomplete by the form’s own terms.
Devices use FM170, not the drug closure form
This is the first trap for teams used to drug trials. On the medicines side, INVIMA’s closure guide uses a different form, ASS-RSA-FM049 (“Formato para notificación de cierre de estudios clínicos”), filed with the Dirección de Medicamentos y Productos Biológicos. That guide also requires each institution’s CEI letter giving its view on the reasons for closure, and it says a simple receipt acknowledgement is not enough.
INVIMA’s device clinical-research page lists the forms currently in force for device studies. They include FM085 (the checklist for the initial protocol review), FM169 (the CEI’s initial evaluation), FM171 (serious adverse event notification) and FM170 (periodic and closure reports). If your global team sends a drug-style closure notice to the device directorate, expect it to come back.
What FM170 actually asks for
The form has four parts. Sponsors tend to underestimate how much of it is reconciliation work across sites, not narrative.
- General aspects (items 1–10). Protocol title, and the number and date of the Sala Especializada de Dispositivos Médicos acta that approved the protocol. Sponsor and CRO details, each with a legal representative, global contact and a contact in Colombia. Then, per site: PI, CEI, and the CEI and INVIMA initial approval actas and dates. After that come the hospital services involved, study type and phase, status per site, primary efficacy and safety outcomes, and percentage achievement of each specific objective.
- Aspects to review (items 10–14). Start-up difficulties, and subject counts per site: screened, screen failures, randomized, excluded, voluntary withdrawals and deaths, with reasons and causes. Next is device accountability: the INVIMA approval acta, import date, final disposition and export date, plus quantities received, used, unused and returned to the sponsor at each site. Last, every adverse event and incident by site and subject code, with serious/non-serious classification, ICD code, causality and outcome, plus a consolidated cause analysis and a global-versus-local safety view.
- Interim results (items 15–19). Whether an external data analysis committee exists and whether it or the CEI issued safety recommendations (attach them). Planned versus executed, covering real start date, supplies, and every amendment since initial approval (protocol, consent, investigator’s brochure, insurance policy, investigators) with CEI and INVIMA actas. Then cumulative protocol deviations from start to finish, each with type, impact on subject and data, actions taken and whether their effectiveness was measured. Finally, an updated risk analysis.
- Final results (items 20–24). Actual end of recruitment against target per site, with a justification if enrollment came in lower or higher. Actual end of visits, actual site closure (with an explanation of any early termination), the final data-analysis report, and achievement of goals, including what was shared with CEIs, publications and other countries’ regulators.
The form is signed by the person who completed it, stating their delegation within the study, and by the principal investigator.
Where closures stall
The pattern we see is consistent, and it has little to do with the science.
1. Top-line results instead of the complete analysis. Sponsors often send a summary slide or an abstract while the clinical study report is still in draft. Item 23 asks for the final data-analysis document. If it doesn’t exist yet, the honest answer is a dated plan for when it will. Sending a summary and hoping it passes doesn’t work.
2. Numbers that don’t reconcile. Because the data are cumulative, the closure report has to agree with every periodic report already filed, every SAE notification and every amendment acta. A subject count, a device quantity or a deviation that doesn’t match an earlier filing is what generates a point-by-point correction request.
3. Nobody left in Colombia. FM170 asks for the sponsor’s and the CRO’s contact in Colombia. By closure, a foreign sponsor without a local entity often has no one: the CRO engagement ended with the last monitoring visit. INVIMA still needs a party that can receive its requirements and answer them. In practice the options are to keep the CRO (or another regulatory representative) engaged through closure, or to formally delegate regulatory management to a site that agrees to take it on. Either way, put it in writing before the last site closes, not after the letter arrives.
4. Device disposition gaps. Item 13 wants final disposition and, where relevant, export dates for the investigational devices. If units were destroyed locally or shipped back without paperwork that ties out to the import records, the file stays open. We covered this in our post on investigational device accountability in first-in-human studies.
5. CEI letters missing. The form requires the ethics committee’s notification and response letters for the report being filed. A closure package sent to INVIMA before each CEI has acknowledged and responded is incomplete.
A closure checklist to start at the last patient visit
- Confirm in the CRO or representative contract who answers INVIMA until the closure acta is issued, and budget for that tail.
- Reconcile subject counts, SAEs and deviations against every periodic FM170 already filed and every FM171 notification.
- Close device accountability per site: received, used, unused, returned, destroyed, exported, with documents.
- Get each CEI’s closure notification and response letter.
- Lock the timeline for the final data-analysis report. If the CSR will come later, say so and give a date.
- List every amendment since initial approval, with its CEI and INVIMA actas.
- Have the PI sign the closure form, and record the delegation of the person who completed it.
Bottom line
Closing a device study in Colombia is a filing, not a formality. INVIMA’s ASS-RSA-FM170 asks for cumulative, reconciled data from every approved site, the CEI letters, device disposition, deviations, an updated risk analysis and the final data-analysis report, signed by the PI. The most common reason a closure stalls is that nobody in Colombia is still responsible for the study. Decide who that is while the study is still running.
Planning a first-in-human or early feasibility device study in Colombia? Our guides to INVIMA approval for first-in-human trials and preparing the INVIMA package cover the start of the study. Our post on DMC, CEC and medical monitor roles covers the safety oversight INVIMA asks about in item 15. If the study leads to registration, the Colombia INVIMA market access page explains how we hold the registro sanitario independently of your distributor.
Sources: INVIMA, ASS-RSA-FM170 Formato para informes periódicos o de cierre de estudios clínicos (version 01, 3 Nov 2023), Dirección de Dispositivos Médicos y Otras Tecnologías; INVIMA, Investigación Clínica – Dispositivos Médicos (list of forms in force; Resolución 8430 de 1993 framework); INVIMA guide for notification of clinical study closure, form ASS-RSA-FM049 (medicines); Resolución 4816 de 2008 Art. 5 (tecnovigilancia event classification, referenced in FM170). This article is general regulatory information, not legal advice. Confirm current requirements with INVIMA before filing.