Industry & Applied R&D

Contract research organisations

Contract research organisations carry out parts of drug development on behalf of sponsors, and the rules that govern them start with the sponsor. Under 21 CFR 312.52 a sponsor may transfer any or all of its obligations to a CRO, and the transfer must be described in writing; any obligation not listed stays with the sponsor, and a CRO that takes one on faces the same regulatory action a sponsor would. The underlying sponsor duties in 21 CFR 312.50 include selecting qualified investigators, monitoring the investigations and promptly reporting significant new risks. Trial conduct follows ICH E6(R3) Good Clinical Practice: its principles and Annex 1 took effect in the EU on 23 July 2025, and Annex 2, on pragmatic and decentralised trials and real-world data, takes effect on 15 January 2027. FDA's 2013 guidance on a risk-based approach to monitoring shapes monitoring plans, and the CDISC TMF Standard, formerly the TMF Reference Model, gives a common structure for the Trial Master File. Submitted study data for FDA and PMDA use CDISC SDTM. Staff credentials come from ACRP (CCRA, CCRC, ACRP-CP and others) and SOCRA (CCRP). CRO teams also work inside the registries and safety systems: CTIS for EU trial applications, results submission to ClinicalTrials.gov, and electronic safety reporting to EudraVigilance.

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Reviewed 5 November 2026 by CASRAI Editorial Board

Sources

21 CFR 312.52 (law.cornell.edu)(read 5 November 2026)
21 CFR 312.50 (law.cornell.edu)(read 5 November 2026)
EMA: ICH E6 Good clinical practice scientific guideline(read 5 November 2026)
FDA: E8(R1) General Considerations for Clinical Studies(read 5 November 2026)
FDA: Oversight of Clinical Investigations, risk-based monitoring(read 5 November 2026)
CDISC: TMF Standard(read 5 November 2026)
CDISC: SDTM(read 5 November 2026)
ACRP: about(read 5 November 2026)
ACRP: certifications(read 5 November 2026)
SOCRA: certification(read 5 November 2026)
Society for Clinical Trials(read 5 November 2026)
EMA: Clinical Trials Information System(read 5 November 2026)
42 CFR 11.44 (law.cornell.edu)(read 5 November 2026)
EMA: EudraVigilance(read 5 November 2026)
WHO: ICTRP(read 5 November 2026)

Field at a glance

Standards and formats

21 CFR 312.52: transfer of obligations to a CRO: A sponsor may transfer any or all IND obligations to a CRO in writing; obligations not listed stay with the sponsor.Website ↗ · Our guide →
21 CFR 312.50: general responsibilities of sponsors: Sponsor duties a CRO may take on: selecting qualified investigators, monitoring, keeping the IND in effect and safety reporting.Website ↗ · Our guide →
ICH E6(R3) Good Clinical Practice (EMA): Principles and Annex 1 in effect in the EU from 23 July 2025; Annex 2 on pragmatic and decentralised trials applies from 15 January 2027.Website ↗ · Our guide →
ICH E8(R1) General Considerations for Clinical Studies: Final FDA guidance (April 2022) adopting the ICH guideline on general considerations for clinical studies.Website ↗ · Our guide →
FDA risk-based monitoring guidance: Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring (August 2013), for sponsor monitoring strategies and plans.Website ↗ · Our guide →
CDISC TMF Standard (formerly TMF Reference Model): Non-mandatory taxonomy and metadata for organising Trial Master File content, governed by CDISC since 2022.Website ↗ · Our guide →
CDISC SDTM: Study Data Tabulation Model, a required standard for study data submitted to FDA and PMDA.Website ↗ · Our guide →

Societies

ACRP (Association of Clinical Research Professionals): Non-profit association for clinical research professionals, founded in 1976, offering training, certification and the Clinical Researcher publication.Website ↗ · Our guide →
ACRP certifications: ACRP-CP, CCRA for monitors, CCRC for coordinators, CPI for investigators, plus ACRP-MDP and ACRP-PM specialties.Website ↗ · Our guide →
SOCRA (Society of Clinical Research Associates): Society operating since 1991 that awards the Certified Clinical Research Professional (CCRP) credential.Website ↗ · Our guide →

Journals

Clinical Trials (Society for Clinical Trials): Peer-reviewed journal on trial design, conduct, analysis, ethics, regulation and policy, from the Society for Clinical Trials.Website ↗

Archives, facilities and data

Clinical Trials Information System (CTIS): EU platform for trial applications under Regulation 536/2014, used by sponsors and regulators throughout a trial.Website ↗ · Our guide →
ClinicalTrials.gov results submission (42 CFR Part 11): Results for applicable clinical trials are due no later than one year after the primary completion date.Website ↗ · Our guide →
EudraVigilance: EMA adverse reaction database; electronic reporting is obligatory for clinical trial sponsors, in the ICH E2B(R3) format.Website ↗ · Our guide →

Preprints and indexes

WHO International Clinical Trials Registry Platform: Search portal across a network of trial registries, with a Universal Trial Number for unambiguous trial identification.Website ↗ · Our guide →

56 pages across 5 topic areas

Clinical Research Administration

CDISC SDTM vs ADaM: Which Standard Applies WhenComparison
SDTM tabulates collected clinical trial data for regulatory submission; ADaM builds the analysis-ready datasets that support the statistical results i…
CDISC Standards for FDA Submissions: SDTM, ADaM, SEND, and Define-XML
CDISC is the nonprofit standards development organization behind SDTM, ADaM, SEND and Define-XML. FDA requires those formats for study data in NDAs, B…
Centralized vs. Decentralized Clinical Trials: How to Choose the Right ModelComparison
Centralized (site-based) and decentralized (DCT) trials share the same regulatory framework but differ sharply in operational burden, infrastructure,…
Challenges and Risks of Launching a Decentralized Clinical Trial
The data-quality, oversight, jurisdictional, equity, retention, and IRB risks a sponsor needs to assess before launching a decentralized or hybrid cli…
Clinical Data Management Certification: CCDA, CCDM, CCDS, and How They Compare to ACRP/SOCRA
How SCDM's CCDA/CCDM/CCDS clinical data management certification ladder works, and how it differs from ACRP (CCRC/CCRA) and SOCRA (CCRP) credentials.…
Clinical Data Management Tools: How EDC, CDMS, CTMS, eTMF, RTSM, and RBM Fit Together
A landscape overview of the clinical trial technology stack -- EDC, CDMS, CTMS, eTMF, RTSM, and RBM platforms -- and how the tool categories relate to…
Clinical Data Management: Processes, Systems, and Standards
What clinical data management covers end-to-end -- EDC build and validation, edit checks, query resolution, source data verification, medical coding,…
Clinical Trial Auditing: Types, Process, and How It Differs From Monitoring
How clinical trial audits differ from routine monitoring and regulatory inspection, who conducts them, the main audit types, and how sponsor auditing…
Clinical Trial Management System (CTMS): What It Is and Does
A clinical trial management system (CTMS) tracks the operational side of a trial — sites, enrollment, monitoring visits, budgets, and regulatory docum…
Clinical Trial Monitoring: Visit Types, Source Data Verification & the Monitoring Plan
What clinical trial monitoring actually involves: the CRA visit types (site initiation, routine/interim, close-out), what monitors check at a site inc…
Clinical Trial Outsourcing: In-House vs. Full-Service CRO vs. FSP — A Sponsor's Decision Framework
A sponsor-side decision framework for clinical trial outsourcing: in-house/hybrid management vs. full-service CRO vs. Functional Service Provider (FSP…
Clinical Trial Site Selection: How Sponsors and CROs Choose Sites
How sponsors and CROs identify, evaluate, and select clinical trial sites: feasibility questionnaires, prior enrollment performance, patient populatio…
Data Management Plan for Clinical Trials: EDC, CRF Flow, Lock & Retention
How a clinical trial DMP differs from a general research DMP: EDC system specification, CRF data flow, database lock procedure, source data verificati…
Decentralized Clinical Trials (DCTs): What They Are, FDA Guidance, and Key Components
What decentralized clinical trials (DCTs) are, FDA's September 2024 final guidance, and the eConsent, remote monitoring, direct-to-participant shipmen…
Developing a Monitoring Plan for Investigator-Initiated Clinical Trials
How to build a risk-based monitoring plan for an investigator-initiated trial: who takes on the sponsor’s monitoring role, what the plan must contain…
Full-Service CRO Monitoring: What Site Staff Should Expect (ICON and Peers)
A practical, site-coordinator-facing guide to how monitoring visits, communication channels, and escalation actually work when a sponsor outsources tr…
GCP Inspections: What FDA and EMA Review, How to Prepare, and How to Respond to a 483
What FDA BIMO and EMA/national GCP inspectors review at a site or sponsor, the most common findings, how to run a mock inspection, and how to structur…
How to Select a Clinical Trial Management System (CTMS): A Buyer's Guide
A practical, vendor-neutral evaluation guide for institutions selecting a CTMS: what it is not (vs. EDC, eIRB, eReg, billing, ERP), core functionality…
Incurred Sample Reanalysis (ISR) Under ICH M10
What ICH M10 requires for incurred sample reanalysis: why real study samples can behave differently from spiked QCs, the sampling percentages, and the…
MedDRA Coding for Trial Safety Data
How MedDRA coding works: the five-level hierarchy (SOC, HLGT, HLT, PT, LLT), MSSO coding conventions, and how sponsors handle MedDRA version upgrades…
On-Site vs. Remote vs. Centralized vs. Risk-Based Monitoring: Clinical Trial Monitoring Types ComparedComparison
On-site, remote, centralized, and risk-based monitoring compared side by side: what each checks, where the review happens, and how ICH E6(R2) expects…
Pharmaceutical CRO Industry: A Sector Overview
A sector-level overview of the pharmaceutical CRO industry: market structure and tiers, why sponsors outsource, typical service lines, and how sponsor…
Pharmacovigilance Certification: What It Is and Which Program Fits
No single required PV credential exists. This guide compares DIA's Safety and Pharmacovigilance Certificate Program, university graduate certificates,…
Pharmacovigilance in Clinical Research: AE, SAE, and SUSAR Reporting
AE, SAE, SUSAR, and UPIRSO are not a simple hierarchy: an AE need not be a UPIRSO, and a UPIRSO need not be an AE at all. A decision table for what co…
Regulatory Intelligence: Building a Monitoring Function
A source taxonomy, monitoring mechanics, and a five-stage triage workflow for building a regulatory intelligence function that feeds submission strate…
Risk-Based Quality Management (RBQM) in Clinical Trials
How quality-by-design and ICH E6(R2)'s risk-based framework build quality into a clinical trial from protocol design onward, rather than relying on do…
SAHPRA: South Africa's Clinical Trial and Bioequivalence Study Authorization Process
SAHPRA authorizes South African clinical trials and bioequivalence studies under Section 21 of the Medicines Act. This guide covers the CTA process, t…
SDV vs. SDR: Source Data Verification vs. Source Data ReviewComparison
Source Data Verification (SDV) compares CRF entries to source documents line by line, traditionally on 100% of data. Source Data Review (SDR) is a ris…
Site Initiation Visit (SIV) Checklist: Regulatory, DoA, Training, IP, and Pharmacy Readiness
A practical, category-by-category site initiation visit checklist covering regulatory documents, the delegation-of-authority log, staff training recor…
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…
Sponsor vs. CRO: What’s the Difference in a Clinical Trial?Comparison
The sponsor initiates a clinical trial and holds regulatory responsibility for it; a CRO is a contracted vendor performing delegated functions. Delega…
The Trial Master File (TMF): Essential Documents, Structure, and Inspection Readiness
What must be in a Trial Master File before, during, and after a trial, how the TMF Reference Model and eTMF/Part 11 fit in, and what inspectors actual…
Toxicokinetics in Nonclinical Safety Studies
Toxicokinetics characterizes systemic exposure achieved within a nonclinical toxicity study, not therapeutic dosing, and is the basis for the exposure…
Trial Master File Checklist: A Zone-by-Zone Guide
A practical trial master file checklist organized by the TMF Reference Model's 11 zones, covering essential documents, sponsor TMF vs. Investigator Si…

Laboratory Compliance & Quality

21 CFR Part 58: GLP Requirements for Nonclinical Studies
How 21 CFR Part 58 governs nonclinical safety studies: the study director's single-point authority, quality assurance unit independence, protocol and…
Computer System Validation (CSV): GAMP 5, IQ/OQ/PQ, and 21 CFR Part 11
What computer system validation actually requires for regulated laboratory systems: the GAMP 5 risk-based approach, GAMP software categories and the c…
Document Control Procedure: The Six-Stage Lifecycle
How a document control procedure governs draft, review, approval, distribution, revision, and withdrawal for controlled documents in a GxP quality sys…
E2B(R3) Data Elements: A Practical ICSR Submission Reference
A practical, section-by-section reference to E2B(R3) ICSR data elements: mandatory vs conditional vs optional, null flavours, and how ICH regional imp…
EudraVigilance Reporting: Registration, EVWEB vs Gateway, and ICSR Timelines
How EudraVigilance registration, EVWEB and gateway submission, the E2B(R3) ICSR format, and EU reporting timelines actually work for MAHs and clinical…
GxP Compliance: What GLP, GCP, GMP, and GDP Actually Require
GxP is an umbrella term for GLP, GCP, GMP, GDP, and related "Good ... Practice" frameworks. This guide explains what they share, which one applies to…
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) 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…
ISO/IEC 17025: What It Actually Accredits and How It Differs from ISO 9001
ISO/IEC 17025:2017 accredits a laboratory’s technical competence for a defined scope of tests or calibrations — it does not certify the organization a…
Running a Mock FDA Inspection: Roles, Document Requests, and Trip-Wire Questions
A practical guide to running a mock FDA inspection: front-room and back-room roles, simulating the document-request cycle, common trip-wire interview…
Signal Detection in Pharmacovigilance: A Practical Process Guide
A practical process guide to pharmacovigilance signal detection: disproportionality analysis (PRR, ROR, EBGM) with a worked PRR/ROR calculation from a…
Validation Master Plan (VMP) for a Regulated Laboratory: Scope, System Inventory, and Periodic Review
A validation master plan is the governing document above individual qualification exercises. This guide applies EU GMP Annex 15 and Annex 11 to a regu…
What Is an FDA Warning Letter?
A plain-language guide to what an FDA Warning Letter is, when FDA issues one, how it differs from a Form 483 or Untitled Letter, and what it means for…
What Is Good Laboratory Practice (GLP)?
A plain-language guide to Good Laboratory Practice (GLP): what it is, why FDA created it, what 21 CFR Part 58 requires, and how GLP differs from GMP a…

Scholarly Publishing

Cortellis: Life Sciences Intelligence Guide
A research guide to Clarivate's Cortellis suite, covering clinical trial data, regulatory intelligence, APIs, and feasibility workflows for CROs.…
CTTI: Clinical Trials Transformation Initiative Guide
CTTI guide: explore the Clinical Trials Transformation Initiative, Quality by Design (QbD) recommendations, and relational data analysis using AACT.…
Drug Information Association: Guide & Scope
A research guide to the Drug Information Association (DIA), covering its 1964 origins, TIRS journal, global annual meeting, and regulatory science rol…
Pharmaprojects: Drug Pipeline Database Guide
A comprehensive guide to Citeline's Pharmaprojects database, covering drug pipeline tracking, Company Compare, Drug Similarity tools, and BD&L workflo…
Society for Clinical Trials: Methods & Scope
A guide to the Society for Clinical Trials (SCT), covering trial methodology, the DMC Registry, the SCT Annual Meeting, and clinical research standard…
Trialtrove: Clinical Trial Intelligence Guide
Explore Citeline Trialtrove: global clinical trial intelligence, study feasibility benchmarking, enrollment analytics, and protocol optimization for C…

Laboratory Operations & Safety

Medable: Decentralized Clinical Trials Platform
Operational guide to Medable: modular decentralized clinical trial architecture, eConsent, eCOA, 21 CFR Part 11 compliance, and clinical site integrat…

Research Tools & Software

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…