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بروتوكولات البحث

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.

01لوحة العرض

كيف يسير العمل.

النظم · حول هذا الموضوعتوضيحي

لوحة البروتوكولات والتكرار

Research protocols · Labs · Quarter 3

تجربتا تكرار قيد التشغيلGCRI · Labs

البروتوكولات

PR-378 sensor driftتجربة ميدانيةنعممعتمدقيد التشغيل
PR-705 AI triageعشوائينعمالشروطالإعداد
PR-694 message recallتجربة مسحيةنعممعتمدمكتمل
PR-360 heat exposureالفوجلاقيد الانتظارمسودة

Replication R-25

الأثر الأصلي
0.4 SD
أثر التكرار
0.2 SD
الحكم
أصغر، بالإشارة نفسها
منشور
مع البيانات والشيفرة

توافر منصات الاختبار

Protocol and replication board: the screen’s structure, terms and states for Research protocols.أسماء مثالية وقيم توضيحية؛ تصميم وليس سجلًا ولا نظامًا حيًا.

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

02السؤال

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.

الآلية

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.

الآلية

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.

الآلية

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.

الآلية

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.

03الأساليب والأدلة

How research protocols is modelled, measured and tested.

النموذج وافتراضاته وبياناته وعدم اليقين فيه، بالصورة التي يفحصها بها عالم أو مهندس. وتتبع البنى أساليب منشورة. والقيم المرسومة توضيحية، وليست نتائج.

النموذج والمعادلات والافتراضات

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

مخاطر العنصر iRi = f(Hi, Ei, Vi, Ci)الخطر والتعرّض وقابلية التأثر والقدرة على المواجهة
الخسارة السنوية المتوقعةEAL = ∑k pk · Lkعلى الأحداث k ذات الاحتمال السنوي p⁨k⁩
النظم المقترنةxt+1 = A xt + B ut + εtA carries the couplings, u the shock, ε the error
افتراضلماذا أُعدّكيف يُختبر
الخطر والتعرّض مستقلان داخل الحدث الواحديُبقي تكامل الخسارة قابلًا للحسابقارن بمطابقة دالة ربط (⁨copula⁩) على السجلات المشتركة
تكون الروابط خطية قرب نقطة التشغيليسمح بانتشار الصدمات عبر ⁨A⁩ادفع خارج النطاق الخطي وقارن
منحنيات الهشاشة قابلة للنقل بين الأماكننادرًا ما تتوافر المنحنيات المحليةالتحقق مقابل الخسائر المرصودة حيثما وُجدت
المدخلات
مجموعات بيانات ذات إصدارات ومزودة ببيان المصدر
المخرجات
توزيعات، لا أرقام منفردة أبدا
الرمز
يُصدر مع بطاقة النموذج والاختبارات
إعادة الإنتاج
البيانات نفسها والشيفرة نفسها والبيئة نفسها والبذرة نفسها
صيغ معيارية للمخاطر وفضاء الحالة؛ والافتراضات المدرجة نموذجية للأسلوب ومعلنة للمراجعة، وليست نتائج.
مبادئ FAIR التوجيهية · GO FAIR وFORCE11⁨W3C PROV⁩ · اتحاد الشبكة العالميةإرشادات بشأن المعالجة المتسقة لأوجه عدم اليقين · الهيئة الحكومية الدولية المعنية بتغير المناخبيانات CEOS الجاهزة للتحليل · لجنة سواتل رصد الأرض
05المؤشرات الفرعية

ما الذي يُقاس، ومدى جودة قياسه.

يحمل كل مؤشر وحدته ووتيرته ونوع المصدر الذي يستند إليه ووسم الأدلة الذي ستحمله القيمة. ولا تُعرض أي قيم: فالبرنامج يقدّمها بموجب سلطته الخاصة.

المؤشرالوحدةوتيرة الإصدارنوع المصدرالوسم
Registration before data collectionpercent of studies with a time-stamped registrationسنويTrial and study registriesالإحصاءات المنشورة
Primary outcome consistencypercent of reports matching the registered primary outcomeسنويRegistry and publication comparisonمرصود
Sample size justificationpercent of protocols with a power or precision rationaleسنويProtocol auditمرصود
Reporting guideline adherencepercent of applicable checklist items reportedلكل دراسةAssessment against CONSORT, PRISMA, ARRIVE or STROBEمُقدَّر
Protocol amendmentscount per study, each with a stated reasonلكل دراسةRegistry history and ethics committee recordsالإحصاءات المنشورة
Registered report availabilitynumber of journals offering the formatسنويCenter for Open Science journal listمُبلَّغ عنه
Results posting timelinessmonths from primary completion to posted resultsلكل دراسةTrial registriesالإحصاءات المنشورة
Randomisation and blinding reportedpercent of eligible studiesسنويRisk-of-bias assessmentsمُقدَّر
06المصادر

من أين تأتي الأدلة.

مجموعات بيانات عامة مسمّاة وسجلات مؤسسية، لكلٍّ منها فئة ترخيصها. ولا تُستخدم المصادر المتاحة بموجب اتفاق إلا وفق شروطها، ولا يُعاد نشرها أبدًا.

المصدرما يقدّمهفئة الترخيص
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 resultsملك عام
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
07القرارات

من يقرر، وما الذي تخدمه الأدلة.

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

من يقررالسؤالالأدلة التي تخدمها هذه الصفحة
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
ممولو البحوثWhether 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

المخرجات التي يُنتجها هذا الموضوع

  • 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
08الأسئلة الجوهرية

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?
09الآليات والمحرّكات

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.

10المناهج والبيانات

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 الاحتمالات والإحصاء. It depends on assumed effect sizes that are often uncertain.

  3. 03

    Causal designs

    Randomisation, difference-in-differences, regression discontinuity and instrumental variables from الاستدلال السببي. 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.

11الأساليب

كيف يُدرس، وما لا تستطيع المناهج قوله.

12Where this page’s references

Where this page’s references lead.

الهيئات والوثائق التي تُقرأ هذه الصفحة في ضوئها. وتتغير الحالات والإصدارات؛ ويقود كل رابط إلى الهيئة المُصدِرة.

13أسئلة

أسئلة وأجوبة.

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.
التقاريرساهم

ساهم بأدلة من هذه الصفحة.

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.

GCRI⁨Labs⁩أدلة Labsالأساليب والجوانب التقنية
⁨Labs⁩

قدّم منهجية أو مجموعة بيانات أو سؤالا.

المعلومات والاستفسارات متاحة اليوم. ويحصل الاستفسار على رقم مرجعي ويحدد الخطوة التالية؛ ولا تُفتح الطلبات والمدفوعات وتخصيصات الحوسبة والتسجيلات إلا حين يتوافر فريقها وشروطها وقدرة المراجعة.