Life & Health Sciences
Clinical medicine and healthcare research
Clinical medicine research covers studies in patients and healthy volunteers, from first-in-human trials to comparative effectiveness research and evidence synthesis. Its literature is searched in PubMed, maintained by NCBI at the US National Library of Medicine, which holds more than 40 million citations; its MEDLINE component covers more than 5,200 journals indexed with MeSH. Manuscripts not yet peer reviewed appear on medRxiv. Trials are registered before enrolment: the ICMJE, whose members include the New England Journal of Medicine, The Lancet, JAMA and The BMJ, requires registration at or before first patient consent in ClinicalTrials.gov or a WHO ICTRP primary registry, and a data sharing statement in every trial report. ClinicalTrials.gov, run by NLM, carries the registration and results duties of FDAAA section 801. Conduct follows ICH E6 Good Clinical Practice; in the EU the E6(R3) principles took effect on 23 July 2025, with Annex 2 due on 15 January 2027. US oversight rests on the Common Rule (45 CFR 46, revised effective July 2018) and on FDA's 21 CFR Parts 50 and 56 for informed consent and IRBs. Reporting follows CONSORT 2025 and SPIRIT 2025, two of more than 700 guidelines in the EQUATOR Network library. Cochrane produces systematic reviews. Funders include the NCATS CTSA Program at more than 60 institutions and PCORI, authorized by Congress in 2010. This hub covers research practice, not clinical advice.
Reviewed 5 November 2026 by CASRAI Editorial Board
- PubMed: about (NCBI/NLM, 40M+ citations, MEDLINE, PMC, Bookshelf)(read 5 November 2026)
- NLM: MEDLINE overview(read 5 November 2026)
- medRxiv: about(read 5 November 2026)
- ClinicalTrials.gov (Wikipedia; clinicaltrials.gov about pages returned only a navigation stub)(read 5 November 2026)
- WHO ICTRP Search Portal(read 5 November 2026)
- Cochrane: about us(read 5 November 2026)
- ICMJE Recommendations: clinical trial registration(read 5 November 2026)
- ICMJE: membership(read 5 November 2026)
- EMA: ICH E6 good clinical practice scientific guideline(read 5 November 2026)
- Common Rule (Wikipedia; hhs.gov and ecfr.gov refused the fetcher)(read 5 November 2026)
- FDA: regulations relating to good clinical practice and clinical trials(read 5 November 2026)
- CONSORT and SPIRIT 2025(read 5 November 2026)
- EQUATOR Network home(read 5 November 2026)
- NCATS: CTSA Program(read 5 November 2026)
- PCORI: about(read 5 November 2026)
Field at a glance
Preprints and indexes
- PubMed
- Free NCBI/NLM search system for more than 40 million biomedical citations, combining MEDLINE, PubMed Central and Bookshelf.Website ↗ · Our guide →
- MEDLINE
- NLM's main bibliographic database: more than 31 million references from more than 5,200 journals, indexed with MeSH, from 1966 on.Website ↗ · Our guide →
- medRxiv
- Preprint server for medical and health-science manuscripts, run by openRxiv; posts are screened but not peer reviewed.Website ↗
Archives, facilities and data
- ClinicalTrials.gov
- NLM-run trial registry, public since 2000; FDAAA section 801 made registration and summary results reporting mandatory for covered trials.Website ↗ · Our guide →
- WHO ICTRP Search Portal
- WHO portal that searches registration records from 20 registries, including ClinicalTrials.gov, ISRCTN, CTIS and ChiCTR; it is not itself a registry.Website ↗ · Our guide →
- Cochrane
- Global, independent non-profit network of health researchers, professionals, patients and carers that produces systematic reviews.Website ↗ · Our guide →
Standards and formats
- ICMJE clinical trial registration requirement
- Registration at or before first patient consent, in ClinicalTrials.gov or a WHO primary registry; trial reports need a data sharing statement.Website ↗ · Our guide →
- ICH E6(R3) Good Clinical Practice
- EMA page: principles and Annex 1 effective 23 July 2025; Annex 2 adopted June 2026 and effective 15 January 2027.Website ↗ · Our guide →
- Common Rule (45 CFR 46)
- US human-subjects rule with Subparts B to D for pregnant women and fetuses, prisoners and children; a major revision took effect in July 2018.Website ↗ · Our guide →
- FDA 21 CFR Parts 50 and 56
- FDA rules on informed consent and on IRBs, listed with Parts 11, 54, 312 and 812 among FDA's good clinical practice regulations.Website ↗ · Our guide →
- CONSORT 2025 and SPIRIT 2025
- Minimum reporting sets for randomised trials: a 30-item CONSORT checklist for results and a 34-item SPIRIT checklist for protocols.Website ↗ · Our guide →
- EQUATOR Network
- Network for health research reporting with a library of 700+ reporting guidelines; many journals require a completed checklist at submission.Website ↗ · Our guide →
Funders and programmes
- NCATS Clinical and Translational Science Awards (CTSA) Program
- NCATS-led network funding more than 60 medical institutions to improve clinical research and train translational scientists.Website ↗ · Our guide →
- PCORI
- Funder of patient-centered comparative clinical effectiveness research, authorized by Congress in 2010 and reauthorized in December 2019.Website ↗ · Our guide →
Journals
- ICMJE member journals
- Include Annals of Internal Medicine, The BMJ, JAMA, The Lancet, Nature Medicine, NEJM and PLOS Medicine, which apply ICMJE recommendations.Website ↗ · Our guide →
117 pages across 12 topic areas
Research Methods & Statistics
- Cardiology vs Pulmonology: What Is the Difference?Comparison
Cardiology covers the heart and blood vessels; pulmonology covers the lungs and breathing. Scope, diagnostics, trial endpoints, funding, training and…
- ICD-10 vs ICD-11: Key DifferencesComparison
Detailed technical comparison between ICD-10 and ICD-11 diagnostic classifications, covering code syntax, Foundation ontology, cluster coding, and res…
- Inter-Rater Reliability: Choosing the Right Coefficient
A selection table from data type and rater design to the right agreement statistic - Cohen's and weighted kappa, Fleiss' kappa, ICC, Krippendorff's al…
- Minimal Detectable Change (MDC): SEM-Based Calculation and the MDC-vs-MCID Decision Rule
What MDC is, the three routes to a standard error of measurement and the assumptions each carries, the MDC95 = 2.77 x SEM calculation worked end to en…
- Nephrology vs Urology: Differences, Overlap and Research FocusComparison
Nephrology is the medical specialty of the kidneys; urology is the medical and surgical specialty of the urinary tract and male reproductive organs. H…
- Net Reclassification Improvement (NRI): The Calculation, and the Case Against It
The NRI compares two risk prediction models by counting who moved in the right direction. This guide gives the arithmetic for both the category-based…
- Pediatrics vs Geriatrics: Research With Children and Older AdultsComparison
Pediatrics covers children and adolescents; geriatrics covers older adults. How they differ on consent and assent, Subpart D, inclusion policy, funder…
- Power Analysis and Sample Size Calculation: A Complete Guide
How to run a power analysis to calculate sample size: the four interlocking quantities (effect size, alpha, power, N), a priori vs. post-hoc power, ch…
- SNOMED vs ICD-10: Clinical Coding DifferencesComparison
Detailed comparison between SNOMED CT clinical terminology and ICD-10 diagnostic classification, covering EHR point-of-care capture, LOINC integration…
- Test-Retest Reliability: Choosing the Retest Interval, and Checking for Drift
The retest interval is the design decision a test-retest coefficient cannot recover from. What the interval trades off, what COSMIN actually asks abou…
- Visual Analogue Scale (VAS): Construction, Scoring and Minimal Important Change
A visual analogue scale is a 100 mm line with two anchors and no marks in between, scored by measured distance. This guide covers the construction rul…
- What Is Cardiology? A Guide to the Discipline
Cardiology is the branch of medicine and biomedical science that studies the heart and blood vessels. This guide covers its subfields, methods, funder…
- What Is Emergency Medicine? Research, Consent, and Training
A guide to emergency medicine as a specialty and research field: scope, subspecialties, how emergency research handles consent under 21 CFR 50.24, res…
- What Is Endocrinology? Research Areas, Funding, and Career Paths
A thorough guide to endocrinology: what it studies, its major subfields, the federal and private funders behind endocrine research, common research me…
- What Is Gastroenterology? A Research and Funding Guide
Gastroenterology is the study of the digestive system and its diseases. This guide covers subfields, microbiome and endoscopy research, NIDDK funding,…
- What Is Health Informatics? Fields, Methods & Careers
Health informatics is the field that uses data, information, and technology to improve health and care delivery. This guide separates it from biomedic…
- What Is Nephrology? Research Areas, Funding, and Career Paths
A thorough guide to nephrology: what it studies, its major subfields, the federal and private funders behind kidney research, how kidney trials measur…
- What Is Obstetrics and Gynecology? Research Areas, Funding, and Career Paths
Obstetrics and gynecology (OB-GYN) is the medical and research discipline of pregnancy, childbirth and the female reproductive system. This guide cove…
- What Is Ophthalmology? Research Areas, Funding, and Training
Ophthalmology is the medical and surgical specialty devoted to the eye and visual system. This guide covers subspecialties, research methods, the Nati…
- What Is Orthopedics? A Research Guide
Orthopedics, also spelled orthopaedics, is the medical and research field covering the musculoskeletal system. Scope, subspecialties, implant and devi…
- What Is Pediatrics? Research, Subspecialties and Funding
Pediatrics is the branch of medicine devoted to the health of infants, children and adolescents. This guide covers its subspecialties, research method…
- What Is Physical Therapy and Rehabilitation Research?
Physical therapy (physiotherapy) and rehabilitation science study how to restore, maintain, and improve movement and function. This guide covers the f…
- What Is Pulmonology? Research Areas, Funding, and Career Paths
A thorough guide to pulmonology: what it studies, its subspecialties, how respiratory research is funded (including NHLBI), common methods and trial e…
- What Is Rheumatology? A Research Guide
Rheumatology is the medical and research field covering arthritis and autoimmune rheumatic diseases. Scope, subfields, NIAMS funding, classification c…
- What Is Urology? Research Areas, Funding, and Training
Urology is the medical and surgical field for the urinary tract and male reproductive organs. Scope, subfields, ties to nephrology, NIDDK funding, the…
Scholarly Publishing
- Anesthesiology Journal: ASA Flagship, Indexing and Peer Titles
The ASA's flagship Anesthesiology journal: NLM identifiers, indexing, its open access sibling, and five peer anesthesia journals compared.…
- bioRxiv vs. medRxiv: Preprint Server ComparisonComparison
bioRxiv and medRxiv are sibling preprint servers -- one for basic life-sciences research, one for clinical and health research with extra ICMJE-aligne…
- BMC Anesthesiology Guide: Scope, APC & Metrics
A guide to BMC Anesthesiology: journal scope, open peer review workflow, $3,290 APC fees, MEDLINE and PMC indexing, and author submission requirements…
- CDASH: CDISC Clinical Data Acquisition Standards
Learn CDASH (CDISC Clinical Data Acquisition Standards Harmonization): eCRF core designations, SDTM mapping by design, EDC build rules, and FDA submis…
- Circulation Journal: Scope, Metrics, and Guide
Circulation journal guide: explore AHA scope, Clarivate impact metrics, 8% acceptance rate, author submission requirements, and hybrid open access fee…
- Epic Cosmos: Clinical Research Database and Platform Guide
A comprehensive guide to Epic Cosmos, covering its 310M+ patient dataset, access tiers, DSVM query tools, AI models, governance rules, and research ap…
- Epistemonikos: Health Evidence Database Guide
A guide to Epistemonikos: how the database works, the Matrix of Evidence, multi-source screening methods, and systematic review retrieval strategies.…
- EudraCT Database: EU Clinical Trials Guide
An operational guide to EudraCT: regulatory scope, EudraCT number formats, CTIS transition rules, and sponsor reporting in the EU Clinical Trials Regi…
- Frontiers in Medicine: Scope, Sections, Fees and Indexing
What Frontiers in Medicine covers, what it excludes, its 21 sections, APCs by article type, waivers and indexing, from the journal's own pages.…
- How to Submit to bioRxiv or medRxiv: A Submission Walkthrough
What bioRxiv is, plus a step-by-step walkthrough for submitting a manuscript to bioRxiv or medRxiv: screening, license choices, and how a posted prepr…
- ICD-11 Guide: Structure, MMS and Coding Tool
Understand ICD-11 architecture, MMS linearization, postcoordination syntax, WHO ICD API access, and the US transition timeline from ICD-10-CM.…
- Is The Lancet Peer Reviewed? Policy and Process
Comprehensive assessment of The Lancet peer-review process: external review workflows, peer-reviewed vs unreviewed sections, database indexing, and ve…
- Levels of Evidence: The OCEBM 2011 Table, GRADE, and Where the Pyramid Breaks
A levels-of-evidence hierarchy ranks study design; GRADE rates certainty in one effect estimate for one outcome. This guide sets out what the OCEBM 20…
- LOINC: The Clinical Observation Standard
A comprehensive guide to LOINC codes, their 6-part structure, search workflows, and the distinction between clinical observations and CPT billing.…
- N3C Data Enclave: Research Access and Governance
Comprehensive guide to the NIH NCATS N3C Data Enclave: clinical data access tiers, institutional DUA and DUR governance, OMOP harmonization, and resea…
- National Joint Registry (NJR): What It Is and How to Use It
What the UK National Joint Registry records, which NJR output suits patients, clinicians and researchers, and how it differs from other joint registri…
- Nephrology Dialysis Transplantation (NDT): Scope, Indexing and Metrics
NDT journal profile: publisher, scope, ISSNs, MEDLINE/PubMed indexing status and displayed metrics, each tied to its source and date.…
- NIH Toolbox: Neurological Assessment Battery Guide
Explore the NIH Toolbox assessment battery for neurological research. Review its four core domains, iPad V3 administration steps, and normative scorin…
- PCORnet: Clinical Research Network & Data Model
Explore PCORnet and its Common Data Model: distributed architecture, Front Door query workflows, governance, and comparative effectiveness research me…
- PROMIS Measures: Patient-Reported Outcomes Guide
An operational guide to PROMIS measures, covering item banks, PROMIS-29 profile forms, Computer Adaptive Testing (CAT), and standardized T-scores.…
- RxNorm: Clinical Drug Nomenclature & API Guide
A technical guide to RxNorm clinical drug nomenclature, covering RxCUI concepts, Term Types (TTY), RxNav tools, REST API queries, and RxNorm vs NDC ma…
- The EQUATOR Network: Which Reporting Guideline Does Your Study Need?
A study-design routing table for the EQUATOR Network's reporting guideline library — CONSORT, PRISMA, STROBE, SPIRIT, STARD, TRIPOD, ARRIVE, SQUIRE, C…
- Trial Sequential Analysis: Monitoring Boundaries for Cumulative Meta-Analysis
How Trial Sequential Analysis adapts group sequential monitoring boundaries and required information size to cumulative meta-analysis, and what the Co…
- UMLS Guide: Unified Medical Language System
Learn how the Unified Medical Language System (UMLS) unifies biomedical vocabularies, how to use the Metathesaurus and UTS API, and how licensing work…
- What Is medRxiv? The Clinical and Health Sciences Preprint Server Explained
medRxiv is a free, open-access preprint server for clinical and health research, launched in June 2019 by Cold Spring Harbor Laboratory, Yale School o…
Patient Safety & Infection Prevention
- ACHC Accreditation: Which Programmes Actually Carry CMS Deeming Authority
CMS grants deeming authority programme by programme, not organisation-wide. Which seven ACHC programmes are deemed, their Federal Register terms, the…
- APACHE II Score: Components, Scoring, and ICU Mortality Prediction
What the APACHE II score is, how its three components (Acute Physiology Score, Age Points, Chronic Health Points) are calculated, its 0-71 range, and…
- ASA Physical Status Classification: What Each Class Means, and Where the Tool Breaks Down
What the ASA Physical Status Classification (ASA-PS I-VI plus the E modifier) actually measures, how it drives preoperative risk stratification, sched…
- CPHQ Certification: The Seven Exam Categories, Their Item Counts, and the Eighth Competency Domain
NAHQ publishes item counts, not percentages, for the CPHQ exam. This page reproduces the 2024 Detailed Content Outline category by category, derives t…
- CPPS Certification: The Four Domains, Their Item Counts, and the 91-Task Second Axis
What the CBPPS content outline and candidate handbook actually publish for the Certified Professional in Patient Safety: four content domains with ite…
- Early Warning Score Implementation: Choosing a Score, Calibrating the Threshold, and Managing Alarm Burden
An implementation guide to early warning scores for deteriorating-patient programme leads: choosing between NEWS2, MEWS and machine-learning scores, c…
- eCQM Reporting for Hospitals: What Each Programme Requires, and Why a Measure Fails on Documentation
eCQMs are computed by a certified EHR from structured data, so a fallout is often a value-set or capture-location defect rather than a care problem. W…
- Epidemic Curve: Choosing the Interval, Onset vs Specimen Date, and Bounding the Exposure Window
The construction decisions behind a hospital epidemic curve: choosing the x-axis interval from the incubation period, why symptom onset and specimen c…
- Failure to Rescue as a Quality Measure: Numerator, Denominator, and What It Proxies
Failure to rescue (FTR) counts deaths conditioned on a prior serious complication, not overall mortality. This guide walks the exact numerator/denomin…
- Hospital Core Measures: A Map From ORYX to eCQMs, and What the Term Means Today
Core measures started as a single, uniform chart-abstracted method shared by the Joint Commission's ORYX initiative and CMS. Here is what the term map…
- Hospital Inpatient Quality Reporting (IQR) Program: Measures, Calendar, and the Payment-Update Penalty
Hospital IQR is a pay-for-reporting program: CMS cuts a hospital’s annual payment update by one-quarter for incomplete submission, not for poor perfor…
- Joint Commission Tracer Methodology: The Survey Sequence, and How a Finding Becomes an RFI
How a Joint Commission tracer actually runs: the tracer types, the questions asked at each stop, and the federally mandated path from an observation t…
- Medication Use Evaluation (MUE): Criteria, Sampling, the Data Form, and the P&T Report
A step-by-step procedure for running a medication use evaluation in a health system: establishing the trigger, writing criteria and thresholds, defini…
- NFPA 101 Life Safety Code in the Hospital Survey: K-Tags, Form CMS-2786R, and the FSES Route
CMS incorporates the 2012 edition of NFPA 101 at 42 CFR 482.41(b) with TIAs 12-1 to 12-4. What a K-tag actually is, how the seven banded sections of F…
- NFPA 99 Health Care Facilities Code: Risk Categories, Medical Gas, and the Edition CMS Actually Enforces
CMS incorporates the 2012 edition of NFPA 99 at 42 CFR 482.41(c), excluding chapters 7, 8, 12 and 13 for hospitals. What the Category 1-4 risk model r…
- NPDB Reporting Requirements for Hospitals: Two Different 30-Day Rules, and the Trigger With No Threshold
The 30-day threshold on a privileges action and the 30-day filing deadline are different rules. The surrender-under-investigation trigger has no thres…
- Rapid Response Team Activation Criteria: Charter, Staffing Model, and Programme Measures
A programme-design guide to rapid response teams: the afferent and efferent limbs, what accreditation actually requires, the activation criteria card,…
- SEP-1: The 3-Hour and 6-Hour Bundle Elements as the Measure Actually Scores Them
SEP-1 is an all-or-nothing, chart-abstracted composite: a hospital can deliver excellent sepsis care and still fail on abstraction technicalities. How…
- SOFA Score and qSOFA Score: Sepsis-3 Organ Dysfunction Scoring
The SOFA score's six organ systems, the three-criteria qSOFA bedside screen, and how both feed the Sepsis-3 definitions of sepsis and septic shock.…
- Tall Man Lettering: Two Different Lists, the CD3 Rule, and Making It Hold Across Every Screen
FDA and ISMP maintain two separate, non-matching tall man lettering lists. How the CD3 capitalisation rule works, how to apply the convention consiste…
- Total Performance Score: How Hospital VBP Turns Four Domains Into a Payment Adjustment
The Total Performance Score is the number that decides whether Medicare pays a hospital back more or less than the 2% it withheld. This guide works th…
Clinical Research Administration
- 21 CFR: What Title 21 of the Code of Federal Regulations Covers
A routing guide to Title 21 of the Code of Federal Regulations: how CFR citations are structured, and which Part governs electronic records, informed…
- ClinicalTrials.gov PRS Login & Account Access
Why the PRS "Organization" login field fails first-time users, how to actually get a PRS account (there's no self-service signup), and how the Moderni…
- ClinicalTrials.gov Registration Requirements for Academic and Investigator-Initiated Trials
Who must register an investigator-initiated trial on ClinicalTrials.gov, how the "applicable clinical trial" test works, the 21-day registration and 1…
- CTRI Registration: Step-by-Step Process, Dataset, Verification and Timelines
How trial registration in the Clinical Trials Registry - India actually works: creating an applicant account, the eight-part dataset, contact-person e…
- Designing a Clinical Trial Protocol: Structure, ICH E6/E8, and Registration
A practical guide to designing a clinical trial protocol: the core sections ICH E6(R2) and E8(R1) expect, how the protocol relates to the SAP, safety…
- DMC Charter: What It Must Include and How Unblinding Procedures Work
What a Data Monitoring Committee charter must document, how open/closed session structure works, the statistical analysis plan handoff, scheduled vs.…
- Form FDA 3674: Certifying ClinicalTrials.gov Compliance With an FDA Submission
Form FDA 3674 certifies compliance with the ClinicalTrials.gov data bank requirements of 42 U.S.C. 282(j). The hard part is not the form — it is…
- Good Documentation Practices (GDP) in Clinical Trials
Good documentation practices (GDP) means applying the ALCOA/ALCOA+ data-integrity principles to clinical trial source documents, case report forms, an…
- ICH E11A Pediatric Extrapolation Guideline: What Sponsors Need to Know
ICH E11A gives sponsors a harmonized framework for using adult or older-pediatric data to support conclusions in younger pediatric populations. Covers…
- ICH E6(R3): What Changed in Good Clinical Practice
ICH E6(R3) restructures Good Clinical Practice into a Principles document plus Annexes, and shifts from prescriptive procedural rules to a risk-propor…
- NMRR Malaysia: Registering a Study in the National Medical Research Register
How to register a study in Malaysia’s National Medical Research Register (NMRR v2.0): the submission workflow, why registration is not MREC ethics app…
- SFDA Saudi Arabia Clinical Trial Authorization: Pathway and SCTR Registration
How Saudi Arabia's SFDA authorizes clinical trials, how the Saudi Clinical Trials Registry (SCTR) functions as both application portal and public regi…
- Sponsor Oversight of Delegated CRO Functions Under ICH E6(R3)
How ICH E6(R3)'s expanded sponsor-oversight framework applies when a sponsor delegates trial functions to a CRO: the Section 3.9 oversight requirement…
- TCTR (Thai Clinical Trials Registry): Registration Process and WHO Primary-Registry Status
How to register a clinical trial in Thailand's TCTR, the WHO 20-item dataset it requires, its ID format, and how it relates to Thai FDA/EC approval.…
Research Integrity & Compliance
- 45 CFR 46 and the Common Rule: What Each Subpart Covers
45 CFR 46 is the HHS human-subjects regulation with five subparts (A-E). The Common Rule is specifically Subpart A. This guide maps every subpart to i…
- 45 CFR 46 vs. 21 CFR 50: How the Common Rule and FDA's Human-Subjects Regulation DifferComparison
45 CFR 46 (the HHS Common Rule) applies because research is federally funded or conducted; 21 CFR 50 applies because a study involves an FDA-regulated…
- Clinical Trial Registration and Reporting Compliance
Why ICMJE requires clinical trial registration as a condition of publication, how that differs from the legal FDAAA/NIH results-reporting mandate, how…
- CONBIOÉTICA Committee Registration in Mexico: CEI, Research and Biosafety Committees Under NOM-012-SSA3-2012
Registering a Comité de Ética en Investigación and its companion research and biosafety committees with CONBIOÉTICA, clause by clause under NOM-012-SS…
- Good Clinical Practice (GCP) Certification: What It Is, Who Needs It, and How to Get It
A practical guide to Good Clinical Practice (GCP) certification: what it is, who requires it, the real providers (CITI, ACRP, SOCRA), renewal cycles,…
- Informed Consent vs. Assent — What's the Difference?Comparison
How informed consent (given by an adult or parent/guardian) differs from a child's own assent under 45 CFR 46.408 — including IRB discretion on age th…
- Ley 20.120 (Chile): Research on Human Beings, the Genome, and Accredited Ethics Committee Requirements
Ley 20.120 and its reglamento, Decreto 114, are the statute behind Chilean ethics review — not the ISP/ANAMED product pathway. This guide sets out the…
- Resolución 8430 de 1993: Colombia's Research Ethics and Risk-Classification Rules
Colombia's foundational research-ethics regulation: the sin riesgo / riesgo mínimo / riesgo mayor risk categories with real examples, informed-consent…
- The Components of Informed Consent: The Required Elements Under 45 CFR 46.116
The required components of informed consent under 45 CFR 46.116: the eight basic elements, the ninth element added in 2018, and the additional element…
- What Is Good Clinical Practice (GCP)?
Good Clinical Practice (GCP) is the ICH E6 standard governing how clinical trials involving human participants are designed, conducted, and reported.…
Laboratory Compliance & Quality
- CLIA Certification: Certificate Types, Complexity Categories, and Whether Your Lab Needs One
A guide to CLIA certification under 42 CFR Part 493: the five certificate types, waived/moderate/high complexity categories, and the research-lab exem…
- ICH E6(R3) Annex 2: Remote Monitoring, Telehealth Visits, and Direct-to-Patient Shipment Oversight
A deep dive into ICH E6(R3) Annex 2's decentralised-trial provisions: remote and risk-based monitoring, telehealth-based visits, and sponsor oversight…
- ICH E6(R3) Data Governance Requirements
How ICH E6(R3)'s Principles govern clinical trial data: the data lifecycle, quality-by-design applied to data, technology-agnostic (media-neutral) req…
- ICH E6(R3) Definitions: Audit, Inspection, Monitoring and Quality Assurance
What ICH E6(R3) actually says an audit, an inspection, monitoring and quality assurance are — each definition quoted verbatim from the Step 4 Glossary…
- Lab Waste Disposal: RCRA Streams, Generator Status, and Disposal Routes
A research lab generates several legally distinct waste streams — RCRA hazardous chemicals, medical/biohazardous waste, sharps, radiological waste, an…
- Proficiency Testing & External Quality Assessment (EQA) for Accredited Labs
How proficiency testing (PT) and external quality assessment (EQA) schemes work under ISO/IEC 17043 and CLIA, including how PT samples must be handled…
Laboratory Operations & Safety
- AABB Standards for Blood Banks and Transfusion Services: What They Are and How to Access Them
A guide to AABB Standards for Blood Banks and Transfusion Services: what it covers, how editions work, how to access it via the AABB Standards Portal…
- ARDS Berlin Definition: Criteria, Classification, and Clinical Scope
The ARDS Berlin definition defines diagnostic criteria, imaging standards, and 3 hypoxemia tiers using PaO2/FiO2 with a minimum PEEP of 5 cm H2O.…
- Cystatin C eGFR: Principles, Equations, and Clinical Accuracy
Understand cystatin C eGFR: learn how race-free CKD-EPI equations, tubular clearance, and KDIGO confirmatory criteria improve renal function estimatio…
- ISBT 128: The Global Labeling Standard for Blood and Tissue Products
ISBT 128 is the global labeling standard for blood, tissue, and cellular therapy products, maintained by ICCBBA. Here's how its barcode and identifica…
- SRTR: Scientific Registry of Transplant Recipients
A comprehensive reference on the Scientific Registry of Transplant Recipients (SRTR), covering its data linkages, risk-adjusted metrics, and research…
- Surviving Sepsis Campaign Guidelines: Protocol
Explore Surviving Sepsis Campaign guidelines: evidence-based recommendations, initial resuscitation bundles, diagnostic lab workflows, and post-ICU re…
Laboratory Equipment & Instrumentation
- Biosafety Cabinet vs. Fume Hood vs. Laminar Flow Hood: Which Do You Need?Comparison
A biosafety cabinet protects worker, sample, and room. A chemical fume hood protects only the worker. A laminar flow hood protects only the sample. Th…
- Pipette Tips: Selection Guide by Application
How to choose pipette tips by application: filter/barrier vs. standard, low-retention vs. standard, sterile vs. autoclavable, and rack vs. bulk format…
- Trach Care Kit: Emergency Contents Checklist
Trach care kit contents compared across SickKids and Alberta Health Services emergency lists, with cuffed add-ons and check cadence.…
Research Tools & Software
- Covidence vs. Rayyan vs. DistillerSR: Systematic Review Software ComparedComparison
Covidence, Rayyan, and DistillerSR compared on screening workflow, deduplication, PRISMA flow diagrams, data extraction, licensing, and regulatory aud…
- The PubMed Advanced Search Builder: Numbered History, Field Tags, and Reading Search Details
The Advanced Search page gives you a Builder, a numbered History and a Search Details expander. The third is the one that matters: PubMed routinely ru…
- What Is a LIMS? Laboratory Information Management System Explained
A Laboratory Information Management System (LIMS) tracks lab samples, workflows, and results with a full audit trail. This guide explains what a LIMS…
Grants Management & Research Funding
- CIOMS Guidelines and CIOMS I Form Safety Guide
Learn how CIOMS guidelines and the CIOMS I form govern pharmacovigilance, expedited adverse reaction reporting, and clinical trial safety compliance.…
- Society of Critical Care Medicine (SCCM): Membership, Grants and Research Programs
What SCCM is, its member-gated research grants (SCCM-Weil and Discovery), and how its journals and programs relate, as described on its official pages…
CRediT & Authorship
- Honorary Authorship in Surgical Subspecialties: Why Prevalence Is So High in Cardiothoracic, Orthopedic, and Spine Journals
Discipline-specific surveys put honorary authorship at 62.7% in cardiothoracic surgery and 41.9% in orthopedic/sports medicine journals — well above g…
Research Data Management
- PhysioNet Credentialed Access: How to Get MIMIC and Other Restricted Data
How PhysioNet's open, restricted, and credentialed access tiers work, and what the credentialing process (CITI training, identity review, and a per-da…
Key terms
- 21 CFR Part 50 (Protection of Human Subjects)
- 21 CFR Part 56 (Institutional Review Boards)
- 45 CFR 46 Subpart A (Basic HHS Policy for Protection of Human Research Subjects)
- 45 CFR 46 Subpart B (Additional Protections for Pregnant Women, Human Fetuses, and Neonates)
- 45 CFR 46 Subpart D (Additional Protections for Children in Research)
- Clinical Trial Registration
- ClinicalTrials.gov
- Common Rule (45 CFR 46)
- Exception from Informed Consent (EFIC) for Emergency Research
- Good Clinical Data Management Practices (GCDMP)
- Good Clinical Laboratory Practice (GCLP)
- Human Fertilisation and Embryology Authority (HFEA)
- ICH E6(R2) (Good Clinical Practice, 2016 Addendum)
- ICH E6(R3) (Good Clinical Practice Guideline Revision)
- ICH GCP (Good Clinical Practice)
- Paediatric Investigation Plan (PIP)
- Prospective Clinical Trial Registration







