Sources & Publications We Follow
The publications and research sources Clinical Research Data Management Guide monitors and cites — curated for people who work in clinical research, not an indiscriminate directory. Inclusion reflects our editorial judgment of reliability and relevance, not affiliation or endorsement. Our News and Research coverage draws primarily from these sources.
Regulators & guidance
U.S. Food and Drug Administration (FDA) (external link)
Covers: Regulations and guidance for clinical trials of medical products, including 21 CFR Part 11, electronic records, and data integrity.
Why we follow it: The primary source for U.S. regulatory requirements that shape clinical data management; everything else is interpretation.
ICH (International Council for Harmonisation) (external link)
Covers: Harmonised guidelines for drug development, including ICH E6 Good Clinical Practice and ICH E9 statistical principles.
Why we follow it: The internationally agreed baseline for trial conduct and data quality that regulators in most major markets adopt.
European Medicines Agency (EMA) (external link)
Covers: EU regulatory guidance, including guidance on computerised systems and electronic data in clinical trials.
Why we follow it: The EU regulator whose data and systems guidance is widely referenced by sponsors and vendors well beyond Europe.
Government research resources
National Institutes of Health (NIH) (external link)
Covers: Federal research funding policy, including the NIH Data Management and Sharing Policy and scientific data-sharing guidance.
Why we follow it: The largest public funder of biomedical research; its data policies set the terms for federally funded studies.
ClinicalTrials.gov (external link)
Covers: Trial registrations, protocols, and results for studies conducted worldwide.
Why we follow it: The primary public record of clinical studies and a first stop for verifying what a trial actually registered and reported.
Office for Human Research Protections (OHRP) (external link)
Covers: The Common Rule, IRB requirements, and human subjects protections for federally supported research.
Why we follow it: The authoritative source on the human subjects framework that governs most academic clinical research.
Standards & data exchange
CDISC (external link)
Covers: Clinical data standards — CDASH, SDTM, ADaM, and ODM — and their implementation guides.
Why we follow it: The standards body whose models are required or expected in regulatory submissions and used throughout data management.
HL7 International (external link)
Covers: Healthcare data-exchange standards, including FHIR.
Why we follow it: The reference standards for moving data between electronic health records and research systems.
Professional organizations
Society for Clinical Data Management (SCDM) (external link)
Covers: Clinical data management practice, including the Good Clinical Data Management Practices (GCDMP) and CCDM certification.
Why we follow it: The closest thing to a canonical practice reference for the clinical data management profession.
Association for Clinical Data Management (ACDM) (external link)
Covers: Clinical data management practice, working groups, and events, strongest in the UK and Europe.
Why we follow it: A practitioner perspective on data management that complements SCDM, with a European vantage point.
DIA (Drug Information Association) (external link)
Covers: Drug development, regulatory science, and clinical technology across disciplines and regions.
Why we follow it: A neutral global forum whose meetings and publications track how data management practice is actually evolving.
Peer-reviewed literature
The New England Journal of Medicine (NEJM) (external link)
Covers: Major clinical trial results and research methodology.
Why we follow it: A benchmark venue for trial reporting — useful for seeing how well-run studies present their data and methods.
JAMIA (Journal of the American Medical Informatics Association) (external link)
Covers: Biomedical and health informatics research, including electronic data capture and clinical research information systems.
Why we follow it: The primary peer-reviewed venue for research on the systems clinical data managers use.
PubMed / PubMed Central (PMC) (external link)
Covers: The biomedical literature, including open-access full text via PMC.
Why we follow it: The index we use to locate and verify the peer-reviewed research our articles cite.
Trade publications
Applied Clinical Trials (external link)
Covers: Clinical trial operations, data management, technology, and regulatory developments.
Why we follow it: Long-running trade coverage of the operational side of clinical research, including EDC and eClinical technology.
Clinical Leader (external link)
Covers: Clinical development strategy, outsourcing, sites, and technology.
Why we follow it: Practitioner-oriented reporting on how sponsors, CROs, and sites adopt clinical technology.
For important contested topics we consult multiple source types — a government primary source, independent research, and sector/practitioner perspectives — without manufacturing "two sides" where the evidence does not support them. See our editorial policy.