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GCRI · Labs

연구 프로토콜

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.

01캔버스

일이 진행되는 방식.

시스템 · 이 주제 주변예시

프로토콜 및 재현 보드

Research protocols · Labs · Quarter 3

반복 실험 두 건 실행 중GCRI · Labs

프로토콜

PR-378 sensor drift현장 실험예승인됨실행 중
PR-705 AI triage무작위화예조건설정
PR-694 message recall설문 실험예승인됨완료
PR-360 heat exposure코호트아니요대기 중초안

Replication R-25

원래 효과
0.4 SD
재현 효과
0.2 SD
판정
더 작고, 같은 부호
발행됨
데이터와 코드와 함께

테스트베드 가용성

Protocol and replication board: the screen’s structure, terms and states for Research protocols.예시 이름과 예시 값으로, 실제 기록이나 운영 중인 시스템이 아닌 설계안입니다.

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

02질문

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.

메커니즘

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.

메커니즘

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.

메커니즘

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.

메커니즘

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.

03방법과 근거

How research protocols is modelled, measured and tested.

모형, 그 가정, 데이터, 불확실성을 과학자나 엔지니어가 확인할 형태로 제시합니다. 구조는 발행된 방법을 따릅니다. 제시된 값은 예시이며 결과가 아닙니다.

모형, 방정식 및 가정

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

요소 i의 리스크Ri = f(Hi, Ei, Vi, Ci)재해, 노출, 취약성, 대처 역량
연간 기대 손실EAL = ∑k pk · Lk연간 확률이 pk
결합 시스템xt+1 = A xt + B ut + εtA carries the couplings, u the shock, ε the error
가정만드는 이유시험 방법
한 사건 안에서 재해와 노출은 서로 독립적임손실 적분을 다루기 쉽게 유지함결합 기록에 적합한 코퓰러와 비교
결합은 운전점 근처에서 선형이다충격이 A를 통해 전파되게 함선형 범위를 넘어 섭동을 주고 비교하십시오
취약성 곡선은 장소 간에 옮겨 쓸 수 있다지역 곡선은 거의 없다관측된 손실이 있는 곳에서는 이에 대해 검증
투입 자료
출처 정보가 있는 버전 관리 데이터세트
산출물
분포이며 결코 단일 숫자가 아님
코드
모델 카드 및 시험과 함께 공개
재현
같은 데이터, 코드, 환경과 시드
표준 리스크 및 상태공간 정식화로, 나열된 가정은 해당 방법에 일반적인 것이며 검토를 위해 명시한 것으로 결과가 아닙니다.
FAIR 지침 원칙 · GO FAIR와 FORCE11W3C PROV · 월드 와이드 웹 컨소시엄불확실성의 일관된 처리에 관한 지침 · IPCCCEOS 분석 준비 데이터(Analysis Ready Data) · 지구관측위성위원회
04In the five domains

Protocols are registered before results in every domain.

05지표

측정되는 것과 그 정확도.

각 지표에는 단위, 주기, 그 뒤의 출처 종류, 값에 붙을 근거 표시가 있습니다. 값은 표시하지 않습니다. 값은 프로그램이 자체 권한으로 제공합니다.

지표단위주기출처 유형라벨
Registration before data collectionpercent of studies with a time-stamped registration연간Trial and study registries공표 통계
Primary outcome consistencypercent of reports matching the registered primary outcome연간Registry and publication comparison관측
Sample size justificationpercent of protocols with a power or precision rationale연간Protocol audit관측
Reporting guideline adherencepercent of applicable checklist items reported연구별Assessment against CONSORT, PRISMA, ARRIVE or STROBE추정
Protocol amendmentscount per study, each with a stated reason연구별Registry history and ethics committee records공표 통계
Registered report availabilitynumber of journals offering the format연간Center for Open Science journal list보고됨
Results posting timelinessmonths from primary completion to posted results연구별Trial registries공표 통계
Randomisation and blinding reportedpercent of eligible studies연간Risk-of-bias assessments추정
06출처

근거의 출처.

이름이 명시된 공개 데이터셋과 기관 기록으로, 각각 라이선스 등급이 있습니다. 협약에 따른 출처는 그 조건에 따라서만 사용하며 결코 재게시하지 않습니다.

출처제공하는 것라이선스 등급
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 results퍼블릭 도메인
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
07결정

누가 결정하며 근거는 무엇에 쓰이는지.

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

결정 주체질문이 페이지가 제공하는 근거
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
연구 재원 제공 기관Whether 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

이 주제가 생산하는 산출물

  • 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
08핵심 질문

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?
09메커니즘과 동인

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.

10방법과 데이터

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 확률과 통계. It depends on assumed effect sizes that are often uncertain.

  3. 03

    Causal designs

    Randomisation, difference-in-differences, regression discontinuity and instrumental variables from 인과 추론. 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.

11방법

연구되는 방식과 방법이 말할 수 없는 것.

  1. 확률과 통계표본 크기와 검정력 계획 · 편향 평가를 포함한 메타분석이곳에서의 적용
  2. 인과 추론과 영향 평가무작위 시범 사업과 단계적 도입 · 준실험적 프로그램 평가이곳에서의 적용
  3. 불확실성 정량화와 모델 검증측정 불확실성 예산 · 시뮬레이션 모델의 민감도 분석이곳에서의 적용
  4. 시스템 공학요구사항에서 검증까지의 추적성 · 단계별 관문 준비 태세 검토이곳에서의 적용
12Where this page’s references

Where this page’s references lead.

이 페이지를 읽을 때 기준이 되는 기구와 문서. 상태와 판은 바뀌며, 각 링크는 발행 기구로 연결됩니다.

13질문

질문과 답변.

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.
보고서기여하기

이 페이지에서 증거를 기여하십시오.

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.

GCRI랩Labs 근거방법 및 기술
랩

방법, 데이터세트 또는 질문을 가져오십시오.

정보와 문의는 오늘부터 열려 있습니다. 문의에는 참조 번호가 부여되고 다음 단계가 안내됩니다. 신청, 결제, 컴퓨팅 할당, 등록은 해당 팀, 약관, 심사 역량이 갖추어졌을 때만 열립니다.