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Protokol penelitian

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.

01Kanvas

Bagaimana pekerjaan berjalan.

Sistem · di sekitar subjek iniIlustratif

Papan protokol dan replikasi

Research protocols · Labs · Quarter 3

Dua replikasi berjalanGCRI · Labs

Protokol

PR-378 sensor driftEksperimen lapanganYaDisetujuiBerjalan
PR-705 AI triageDiacakYaKondisiPenyiapan
PR-694 message recallEksperimen surveiYaDisetujuiSelesai
PR-360 heat exposureKohortTidakTertundaDraf

Replication R-25

Efek asli
0.4 SD
Efek replikasi
0.2 SD
Putusan
Lebih kecil, tanda sama
Diterbitkan
dengan data dan kode

Ketersediaan testbed

Protocol and replication board: the screen’s structure, terms and states for Research protocols.Nama contoh dan nilai ilustratif; sebuah rancangan, bukan catatan atau sistem yang aktif.

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

02Pertanyaannya

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.

Mekanisme

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.

Mekanisme

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.

Mekanisme

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.

Mekanisme

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.

03Metode dan bukti

How research protocols is modelled, measured and tested.

Model, asumsi, data, dan ketidakpastiannya, dalam bentuk yang akan diperiksa ilmuwan atau insinyur. Strukturnya mengikuti metode yang dipublikasikan. Nilai yang digambar bersifat ilustratif, bukan temuan.

Model, persamaan, dan asumsi

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

Risiko elemen iRi = f(Hi, Ei, Vi, Ci)bahaya, keterpaparan, kerentanan, dan kapasitas penanggulangan
Kerugian tahunan yang diharapkanEAL = ∑k pk · Lkatas peristiwa k dengan probabilitas tahunan pk
Sistem terhubungxt+1 = A xt + B ut + εtA carries the couplings, u the shock, ε the error
AsumsiMengapa ini dibuatBagaimana ini diuji
Bahaya dan eksposur bersifat independen dalam satu peristiwaMenjaga integral kerugian tetap dapat dihitungBandingkan dengan pencocokan kopula pada catatan gabungan
Keterkaitan bersifat linear di dekat titik operasiMembiarkan guncangan merambat melalui AUji di luar rentang linear lalu bandingkan
Kurva kerentanan dapat dipindahkan antartempatKurva lokal jarang tersediaValidasi terhadap kerugian teramati jika tersedia
Masukan
dataset berversi dengan asal-usul yang tercatat
Keluaran
distribusi, bukan angka tunggal
Kode
dirilis bersama kartu model dan pengujiannya
Reproduksi
data, kode, lingkungan, dan seed yang sama
Formulasi risiko standar dan ruang keadaan; asumsi yang tercantum lazim bagi metode tersebut, dinyatakan untuk ditinjau, bukan hasil.
Prinsip panduan FAIR · GO FAIR dan FORCE11W3C PROV · World Wide Web ConsortiumPanduan penanganan ketidakpastian secara konsisten · IPCCCEOS Analysis Ready Data · Committee on Earth Observation Satellites
04In the five domains

Protocols are registered before results in every domain.

05Indikator

Apa yang diukur, dan seberapa baik.

Setiap indikator membawa satuan, frekuensi, jenis sumber di baliknya, dan label bukti yang akan dibawa suatu nilai. Tidak ada nilai yang ditampilkan: sebuah program menyediakannya berdasarkan wewenangnya sendiri.

IndikatorUnitKadensiJenis sumberLabel
Registration before data collectionpercent of studies with a time-stamped registrationtahunanTrial and study registriesStatistik terbitan
Primary outcome consistencypercent of reports matching the registered primary outcometahunanRegistry and publication comparisonTERAMATI
Sample size justificationpercent of protocols with a power or precision rationaletahunanProtocol auditTERAMATI
Reporting guideline adherencepercent of applicable checklist items reportedper studiAssessment against CONSORT, PRISMA, ARRIVE or STROBEESTIMASI
Protocol amendmentscount per study, each with a stated reasonper studiRegistry history and ethics committee recordsStatistik terbitan
Registered report availabilitynumber of journals offering the formattahunanCenter for Open Science journal listDILAPORKAN
Results posting timelinessmonths from primary completion to posted resultsper studiTrial registriesStatistik terbitan
Randomisation and blinding reportedpercent of eligible studiestahunanRisk-of-bias assessmentsESTIMASI
06Sumber

Asal bukti.

Set data publik bernama dan catatan kelembagaan, masing-masing dengan kelas lisensinya. Sumber berdasarkan perjanjian hanya digunakan sesuai ketentuannya dan tidak pernah diterbitkan ulang.

SumberApa yang diberikannyaKelas lisensi
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 resultsDomain publik
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
07Keputusan

Siapa yang memutuskan, dan apa yang dilayani bukti.

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

Siapa yang memutuskanPertanyaannyaBukti yang dilayani halaman ini
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
Penyandang dana penelitianWhether 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

Keluaran yang dihasilkan topik ini

  • 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
08Pertanyaan inti

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?
09Mekanisme dan pendorong

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.

10Metode dan 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 probabilitas dan statistika. It depends on assumed effect sizes that are often uncertain.

  3. 03

    Causal designs

    Randomisation, difference-in-differences, regression discontinuity and instrumental variables from inferensi kausal. 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.

11Metode

Cara hal ini dikaji, dan apa yang tidak dapat dinyatakan metodenya.

  1. Probabilitas dan statistikaPerencanaan ukuran sampel dan daya uji · Meta-analisis dengan penilaian biasDiterapkan di sini
  2. Inferensi kausal dan evaluasi dampakUji coba teracak dan peluncuran bertahap · Evaluasi program kuasi-eksperimentalDiterapkan di sini
  3. Kuantifikasi ketidakpastian dan validasi modelAnggaran ketidakpastian pengukuran · Analisis sensitivitas model simulasiDiterapkan di sini
  4. Rekayasa sistemKetertelusuran dari persyaratan hingga verifikasi · Tinjauan kesiapan per tahapDiterapkan di sini
12Where this page’s references

Where this page’s references lead.

Badan dan dokumen yang menjadi acuan halaman ini. Status dan edisi berubah; setiap tautan menuju badan penerbitnya.

13Pertanyaan

Tanya jawab.

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.
LaporanBerkontribusi

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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.

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