Skip to content

GCRI · Labs

Protokolên lêkolînê

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.

01Canvas

Xebat çawa dimeşe.

Pergal · li dora vê mijarêNimûneyî

Tabloya protokol û dubarekirinê

Research protocols · Labs · Quarter 3

Du dubarekirin dixebitinGCRI · Labs

Protokol

PR-378 sensor driftCeribandina zeviyêErêPejirandîDixebite
PR-705 AI triageRasthatîErêŞertSazkirin
PR-694 message recallCeribandina anketêErêPejirandîTemam
PR-360 heat exposureKohNaLi bendêPêşnûme

Replication R-25

Bandora eslî
0.4 SD
Bandora dubarekirinê
0.2 SD
Biryar
Piçûktir, heman nîşan
Hatiye weşandin
bi dane û kodê

Peydabûna cihê ceribandinê

Protocol and replication board: the screen’s structure, terms and states for Research protocols.Nav û nirxên nimûneyî; sêwiran e, ne qeyd an pergaleke zindî ye.

ŞeklProtocol and replication board: example names and illustrative values, not a record or a live system.

02The question

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.

Mekanîzma

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.

Mekanîzma

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.

Mekanîzma

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.

Mekanîzma

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.

03Rêbaz û delîl

How research protocols is modelled, measured and tested.

Model, texmînên wî, daneyên wî û nediyariya wî, bi şeweyê ku zanyar an endezyar kontrol bike. Avahî rêbazên weşandî dişopînin. Nirxên hatine xêzkirin nimûneyî ne, ne encam in.

Model, hevkêşe û texmîn

The model structure used for research protocols, the assumptions it makes and how each is tested.

Xetera hêmana iRi = f(Hi, Ei, Vi, Ci)metirsî, rûbirûbûn, lawazî û kapasîteya serederiyê
Windahiya salane ya hêvîkirîEAL = ∑k pk · Lkli ser bûyerên k bi îhtîmala salane pk
Pergalên girêdayîxt+1 = A xt + B ut + εtA carries the couplings, u the shock, ε the error
TexmînÇima tê çêkirinÇawa tê ceribandin
Metirsî û rûbirûbûn di nav bûyerekê de serbixwe neEntegrala windahiyê ji hesabkirinê re maqûl dihêleBi lihevhatineke copula li ser tomarên hevbeş re bidin ber hev
Girêdan li nêzî xala xebatê xêzik inDihêle şok di A de belav bibinJi derveyî rêza xêzik tevlihev bike û bide ber hev
Xêzên lawaziyê di navbera cihan de têne veguhastinXêzikên herêmî kêm tên dîtinLi hember windahiyên çavdêrîkirî erê bike li cihê ku hene
Têketin
danehevên bi guhertoyan û çavkaniyê
Derketin
belavkirin, tu carî jimarên tenê
Kod
bi qerta modelê û ceribandinan re hat weşandin
Zêdebûn
heman dane, kod, jîngeh û tov
Formulasyonên standard ên xetereyê û qada rewşê; texmînên navborî ji bo rêbazê tîpîk in, ji bo nirxandinê hatine diyarkirin, ne encam in.
Prensîbên rêber ên FAIR · GO FAIR û FORCE11W3C PROV · World Wide Web ConsortiumRêwerzên ji bo birêvebirina hevgirtî ya nediyarîyan · IPCCCEOS Analysis Ready Data · Committee on Earth Observation Satellites
04In the five domains

Protocols are registered before results in every domain.

05Nîşander

What is measured, and how well.

Each indicator carries its unit, its cadence, the kind of source behind it and the evidence label a value would carry. No values are shown: a programme supplies them under its own authority.

IndicatorUnitCadenceSource typeNîşan
Registration before data collectionpercent of studies with a time-stamped registrationannualTrial and study registriesStatîstîkên weşandî
Primary outcome consistencypercent of reports matching the registered primary outcomeannualRegistry and publication comparisonÇAVDÊRÎKIRÎ
Sample size justificationpercent of protocols with a power or precision rationaleannualProtocol auditÇAVDÊRÎKIRÎ
Reporting guideline adherencepercent of applicable checklist items reportedper studyAssessment against CONSORT, PRISMA, ARRIVE or STROBETEXMÎNKIRÎ
Protocol amendmentscount per study, each with a stated reasonper studyRegistry history and ethics committee recordsStatîstîkên weşandî
Registered report availabilitynumber of journals offering the formatannualCenter for Open Science journal listREPORTED
Results posting timelinessmonths from primary completion to posted resultsper studyTrial registriesStatîstîkên weşandî
Randomisation and blinding reportedpercent of eligible studiesannualRisk-of-bias assessmentsTEXMÎNKIRÎ
06Çavkanî

Where the evidence comes from.

Named public datasets and institutional records, each with its licence class. Sources by agreement are used only under their terms and never republished.

ÇavkanîWhat it givesLicence class
OSF Registries (Center for Open Science)Time-stamped preregistrations and registered report protocols across disciplinesOpen, licence per registration
ClinicalTrials.gov (US National Library of Medicine)Registered trials, protocol change history and posted resultsGiştî
WHO International Clinical Trials Registry PlatformSearch across primary national trial registriesFree, WHO terms of use
PROSPERO (NIHR)Registered protocols for systematic reviewsFree access, terms of use
protocols.ioVersioned, citable step-by-step laboratory and field methodsOpen, CC BY for public protocols
EQUATOR Network libraryReporting guidelines by study design, with extensionsFree access, licence per guideline
Crossref metadataLinks between registrations, articles, corrections and fundersOpen metadata, no restrictions
07Biryar

Who decides, and what the evidence serves.

Labs prepares evidence. The decisions below are taken by the authorities named, under their own rules, and never by the platform.

Kî biryarê dideThe questionEvidence this page serves
Research ethics committees and institutional review boardsWhether a protocol’s risks, consent and design justify approval, and whether an amendment needs fresh reviewComplete protocol, sample size rationale, amendment history with reasons
Journal editorsWhether to accept a registered report in principle, or whether a submitted analysis matches its planTime-stamped registration compared line by line with the manuscript
Research fundersWhether a proposal’s design can answer its question before money is committedPower or precision rationale, control conditions, data management plan
Medicines and device regulatorsWhether trial evidence was generated under the protocol submitted to themRegistry history, deviation logs, results posting record

Outputs this topic produces

  • 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
08Core questions

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?
09Mechanisms and drivers

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.

10Methods and data

Tools protocols draw on, and where they stop.

  1. 01

    Pre-registration

    A time-stamped record of hypotheses and analysis plans. It limits post hoc changes but cannot stop a poorly chosen question.

  2. 02

    Power and design analysis

    Estimates how much data is needed to detect a meaningful effect, using îhtîmal û statîstîk. It depends on assumed effect sizes that are often uncertain.

  3. 03

    Causal designs

    Randomisation, difference-in-differences, regression discontinuity and instrumental variables from causal inference. Each rests on assumptions that must be stated and, where possible, tested.

  4. 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.

11Rêbaz

How it is studied, and what the methods cannot say.

  1. Îhtîmal û statîstîkSample size and power planning · Meta-analysis with bias assessmentApplied here
  2. Encamgirtina sedemî û nirxandina bandorêRandomised pilots and stepped rollouts · Quasi-experimental programme evaluationApplied here
  3. Pîvandina nediyariyê û rastandina modelêMeasurement uncertainty budgets · Sensitivity analysis of simulation modelsApplied here
  4. Endezyariya pergalanRequirements to verification traceability · Stage-gate readiness reviewsApplied here
12Where this page’s references

Where this page’s references lead.

Sazî û belgeyên ku ev rûpel li hember wan tê xwendin. Rewş û çap diguherin; her girêdan diçe ba saziya derxistinê.

13Pirs

Pirs û bersiv.

What is the difference between a preregistration and a registered report?
A preregistration is a time-stamped plan deposited before analysis. A registered report is a journal format in which the plan is peer reviewed and accepted in principle before results exist, so publication does not depend on the outcome.
Does preregistration forbid exploratory analysis?
No. It separates the two. Planned analyses are reported as confirmatory; analyses suggested by the data are reported as exploratory, with that label, so readers can weigh them accordingly.
Which reporting guideline applies to my study?
It depends on the design: CONSORT for randomised trials, SPIRIT for trial protocols, PRISMA for systematic reviews, ARRIVE for animal research, STROBE for observational studies. The EQUATOR Network keeps the current list and extensions.
Can a protocol be changed after registration?
Yes, with a dated amendment and a stated reason, and with fresh ethics review where the change affects participants. What damages credibility is undisclosed change, not change itself.
Is pre-registration required for every Labs study?
It is designed to be the default for confirmatory work. Exploratory work is welcome but is labelled as exploratory, so that its findings are treated as hypotheses rather than conclusions.
Can a protocol change during a study?
Yes, for good reasons such as safety or an unforeseen data problem. Each change is dated, justified and reported alongside the result.
Who writes the protocol?
The research team writes it; a subject reviewer independent of the team is designed to check it before work begins.
rêzeya Pergalên StratejîkTevkarî bike

Ji vê rûpelê delîl bidin.

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.

GCRILabsDelîlên LabsRêbaz û teknîkî
Labs

Rêbazek, danehevek an pirsek bîne.

Agahî û pirs îro vekirî ne. Pirsek referansekê distîne û gava piştî wê dide nasîn; serlêdan, drav, veqetandina hesabkirinê û tomarkirin tenê dema ku tîm, mercên wê û kapasîteya vekolînê hebin vedibin.