GCRI · Labs
Protocolos de investigación
A research protocol fixes, before data are collected, what a study asks, how it will answer and what would count as an answer: the hypotheses, the design, the controls, the outcomes, the sample and the analysis. Many failures of credibility trace back to a protocol that was vague, unwritten or changed after the data were seen. This page sets out how protocols are built, registered, reviewed and reported, and what ethics committees, editors and funders rely on when they accept a study’s claims.
Cómo se desarrolla el trabajo.
Panel de protocolos y replicación
Research protocols · Labs · Quarter 3
Protocolos
| PR-378 sensor drift | Experimento de campo | Sí | Aprobado | En ejecución |
| PR-705 AI triage | Aleatorizado | Sí | Condiciones | Configuración |
| PR-694 message recall | Experimento de encuesta | Sí | Aprobado | Completo |
| PR-360 heat exposure | Cohorte | No | Pendiente | Borrador |
Replication R-25
- Efecto original
- 0.4 SD
- Efecto de réplica
- 0.2 SD
- Veredicto
- Menor, mismo signo
- Publicado
- con datos y código
Disponibilidad de los bancos de pruebas
Fig.Protocol and replication board: example names and illustrative values, not a record or a live system.
Research protocols: how the risk develops.
Hypotheses, controls and scientific acceptance. The dossier below sets out how the risk develops, what is measured, where the data come from, how it is modelled and who decides.
Flexibility becomes bias
When outcomes, exclusions, covariates or stopping rules are chosen after the data are seen, many analyses become possible and the most striking one tends to be reported. Each choice looks reasonable alone; together they inflate false positives and effect sizes.
Weak controls confound results
A missing control, unblinded assessment or non-random allocation lets something other than the intervention explain the difference. Design flaws cannot be repaired by analysis; they travel into every result and review built on the study.
Underpowered designs mislead twice
Small samples miss real effects, and the effects they do detect tend to be overestimated. Underpowered studies that reach significance seed literatures that later, larger replications cannot match.
Deviations go unreported
Protocols change for good reasons, such as slow recruitment or a safety signal. When a change is not dated, explained and reported, readers cannot tell a justified amendment from outcome switching, and reviews pool what should not be pooled.
How research protocols is modelled, measured and tested.
El modelo, sus supuestos, sus datos y su incertidumbre, en la forma en que un científico o un ingeniero los comprobaría. Las estructuras siguen métodos publicados. Los valores representados son ilustrativos, no hallazgos.
Modelo, ecuaciones y supuestos
The model structure used for research protocols, the assumptions it makes and how each is tested.
Ri = f(Hi, Ei, Vi, Ci)amenaza, exposición, vulnerabilidad y capacidad de afrontamientoEAL = ∑k pk · Lksobre los eventos k con probabilidad anual pkxt+1 = A xt + B ut + εtA carries the couplings, u the shock, ε the error| Supuesto | Por qué se hace | Cómo se prueba |
|---|---|---|
| La amenaza y la exposición son independientes dentro de un evento | Mantiene manejable la integral de pérdidas | Comparar con un ajuste de cópula sobre registros conjuntos |
| Los acoplamientos son lineales cerca del punto de operación | Permite que las perturbaciones se propaguen a través de A | Perturbar más allá del rango lineal y comparar |
| Las curvas de vulnerabilidad se transfieren entre lugares | Las curvas locales rara vez están disponibles | Validar frente a las pérdidas observadas cuando existan |
- Entradas
- conjuntos de datos versionados con procedencia
- Resultados
- distribuciones, nunca cifras únicas
- Código
- publicado con la ficha de modelo y las pruebas
- Reproducción
- mismos datos, código, entorno y semilla
Protocols are registered before results in every domain.
- SaludEn la prácticaTrials register protocols following SPIRIT.What a reader can checkRegistration before enrolment
- AguaEn la prácticaField experiments state hypotheses and methods first.What a reader can checkPre-registration
- AlimentaciónEn la prácticaAgricultural trials state sites, seasons and treatments.What a reader can checkTrial registry
Protocols feed the serie Labs Evidence. Registered serie Reports and EQUATOR guidelines set practice; studies with people follow the Declaration of Helsinki (revised 2024).
- Protocols for review.
- Replication proposals.
Qué se mide y con qué calidad.
Cada indicador lleva su unidad, su periodicidad, el tipo de fuente que lo respalda y la etiqueta de evidencia que llevaría un valor. No se muestran valores: un programa los aporta bajo su propia autoridad.
| Indicador | Unidad | Cadencia | Tipo de fuente | Etiqueta |
|---|---|---|---|---|
| Registration before data collection | percent of studies with a time-stamped registration | anual | Trial and study registries | Estadísticas publicadas |
| Primary outcome consistency | percent of reports matching the registered primary outcome | anual | Registry and publication comparison | OBSERVADO |
| Sample size justification | percent of protocols with a power or precision rationale | anual | Protocol audit | OBSERVADO |
| Reporting guideline adherence | percent of applicable checklist items reported | por estudio | Assessment against CONSORT, PRISMA, ARRIVE or STROBE | ESTIMADO |
| Protocol amendments | count per study, each with a stated reason | por estudio | Registry history and ethics committee records | Estadísticas publicadas |
| Registered report availability | number of journals offering the format | anual | Center for Open Science journal list | NOTIFICADO |
| Results posting timeliness | months from primary completion to posted results | por estudio | Trial registries | Estadísticas publicadas |
| Randomisation and blinding reported | percent of eligible studies | anual | Risk-of-bias assessments | ESTIMADO |
De dónde procede la evidencia.
Conjuntos de datos públicos y registros institucionales identificados, cada uno con su tipo de licencia. Las fuentes obtenidas por acuerdo solo se utilizan conforme a sus condiciones y nunca se republican.
| Fuente | Lo que aporta | Tipo de licencia |
|---|---|---|
| OSF Registries (Center for Open Science) | Time-stamped preregistrations and registered report protocols across disciplines | Open, licence per registration |
| ClinicalTrials.gov (US National Library of Medicine) | Registered trials, protocol change history and posted results | Dominio público |
| WHO International Clinical Trials Registry Platform | Search across primary national trial registries | Free, WHO terms of use |
| PROSPERO (NIHR) | Registered protocols for systematic reviews | Free access, terms of use |
| protocols.io | Versioned, citable step-by-step laboratory and field methods | Open, CC BY for public protocols |
| EQUATOR Network library | Reporting guidelines by study design, with extensions | Free access, licence per guideline |
| Crossref metadata | Links between registrations, articles, corrections and funders | Open metadata, no restrictions |
Quién decide y a qué sirve la evidencia.
Laboratorios prepares evidence. The decisions below are taken by the authorities named, under their own rules, and never by the platform.
| Quién decide | La pregunta | Evidencia a la que sirve esta página |
|---|---|---|
| Research ethics committees and institutional review boards | Whether a protocol’s risks, consent and design justify approval, and whether an amendment needs fresh review | Complete protocol, sample size rationale, amendment history with reasons |
| Journal editors | Whether to accept a registered report in principle, or whether a submitted analysis matches its plan | Time-stamped registration compared line by line with the manuscript |
| Financiadores de la investigación | Whether a proposal’s design can answer its question before money is committed | Power or precision rationale, control conditions, data management plan |
| Medicines and device regulators | Whether trial evidence was generated under the protocol submitted to them | Registry history, deviation logs, results posting record |
Productos que genera este tema
- Protocol templates stating hypotheses, controls, outcomes and analysis plans before data collection
- Registration records with time stamps and version history
- Deviation logs that date and explain every amendment
- Reporting checklists completed against the relevant EQUATOR guideline
What experts ask of any protocol.
- What exactly is the hypothesis, and what result would count against it?
- What is the comparison: a control group, a baseline period, a counterfactual model or a randomised arm?
- Which outcomes are primary, which are secondary, and how will each be measured?
- What sample, duration or number of runs is needed to detect an effect of the size that matters?
- What would make the team stop early, for safety or for futility, and who decides?
- What will be published if the result is null or the experiment fails?
Why experiments drift without a protocol.
Every experiment involves choices: which observations to exclude, which covariates to adjust for, which time window to use. Each choice may be reasonable alone, but when they are made after seeing the data, the number of possible analyses grows quickly and one of them will usually show something. This is the problem methodologists call analytic flexibility, and it is a central reason why published effects often shrink or vanish when repeated.
Interdisciplinary work adds its own drivers. Disciplines differ in what they treat as a control, how they handle missing data and what level of evidence they expect. A hydrologist, an economist and an epidemiologist may each consider a design rigorous by their own standard while disagreeing about what it shows. A protocol forces those differences into the open before work starts.
Incentives matter too. Positive, novel findings are easier to publish and fund, which rewards flexibility and penalises null results. Pre-registration and registered reports are the main structural responses.
Tools protocols draw on, and where they stop.
- 01
Pre-registration
A time-stamped record of hypotheses and analysis plans. It limits post hoc changes but cannot stop a poorly chosen question.
- 02
Power and design analysis
Estimates how much data is needed to detect a meaningful effect, using probabilidad y estadística. It depends on assumed effect sizes that are often uncertain.
- 03
Causal designs
Randomisation, difference-in-differences, regression discontinuity and instrumental variables from inferencia causal. Each rests on assumptions that must be stated and, where possible, tested.
- 04
Acceptance criteria
Pre-agreed thresholds for when a method, model or prototype is considered to work. They make success testable but can be gamed if set too loosely.
A protocol cannot make a bad measurement good or fix a biased sample. Deviations from protocol are permitted when justified, but are reported with their reasons.
Cómo se estudia y lo que los métodos no pueden decir.
- 01Probabilidad y estadísticaPlanificación del tamaño muestral y la potencia · Metaanálisis con evaluación de sesgosAplicado aquí
- 02Inferencia causal y evaluación de impactoPilotos aleatorizados y despliegues escalonados · Evaluación cuasiexperimental de programasAplicado aquí
- 03Cuantificación de la incertidumbre y validación de modelosPresupuestos de incertidumbre de medición · Análisis de sensibilidad de modelos de simulaciónAplicado aquí
- 04Ingeniería de sistemasTrazabilidad de los requisitos a la verificación · Revisiones de preparación por etapasAplicado aquí
Where this page’s references lead.
Los organismos y documentos con los que se lee esta página. El estado y las ediciones cambian; cada enlace lleva al organismo emisor.
Preguntas y respuestas.
What is the difference between a preregistration and a registered report?
Does preregistration forbid exploratory analysis?
Which reporting guideline applies to my study?
Can a protocol be changed after registration?
Is pre-registration required for every Labs study?
Can a protocol change during a study?
Who writes the protocol?
Aporte evidencia desde esta página.
Reports is the Consortium’s quarterly publication. What you know about this subject can become evidence, a case or a correction in the next edition, credited to you and published under CC BY 4.0 where it is your own work.
- Correo electrónicoPasarela GW-GCRIEnvíelo desde esta páginaEvidencia, una corrección, un caso, un método, una revisión, una traducción o un aporte a un perfil. Llega etiquetado con esta página, de modo que lo recibe el editor responsable.
- ZenodoDepósito abiertoDeposítelo y envíelo a la comunidadPublique su propio registro en Zenodo con su ORCID iD y luego envíelo a la comunidad de Reports allí. Los curadores lo revisan; el DOI sigue siendo suyo.
- serie ReportsGCRIVer todas las formas de contribuirLos tipos de contribución, cómo se revisa cada uno, qué crédito recibe, la licencia y qué nunca se acepta.
No envíe nunca datos personales, detalles sensibles de infraestructura ni nada que no tenga derecho a compartir. Un aporte se revisa antes de su uso; enviarlo no confiere autoría ni derechos editoriales, y el patrocinio nunca compra un hallazgo.
Aporte un método, un conjunto de datos o una pregunta.
La información y las consultas están abiertas hoy. Una consulta recibe una referencia e indica el siguiente paso; las solicitudes, pagos, asignaciones de cómputo y registros solo se abren cuando existen su equipo, sus condiciones y la capacidad de revisión.
Documentos jurídicos.
Los mapas, datos y cifras de este sitio se muestran como contexto e información general. No son consejos, pronósticos ni avisos; los límites de la información se exponen en los Descargos de responsabilidad y los Avisos sobre datos.