This is a systematic rapid review published in Wellcome Open Research (2023; 8:194). It analyses evidence on community engagement and informed consent in adaptive platform and alternative design trials conducted during public health emergencies (PHEs) such as Ebola and COVID-19. The review includes 49 publications and guidance documents, highlighting key ethical and communication challenges in explaining complex trial designs under emergency conditions.

ClinicalTrials.gov is a publicly accessible registry and results database of publicly and privately supported clinical studies of human participants conducted worldwide. It provides structured information on study design, eligibility criteria, outcomes, locations, recruitment status and results (including adverse events) for interventional and observational studies, as well as expanded access records. The “Study Documents” tab on individual study records allows users to access uploaded documents such as protocols, statistical analysis plans and informed consent forms where available. It can support SAP development by providing reusable templates, that can serve as starting points for new studies, reducing the effort required to draft standard sections.
Statisticians can review how similar trials handled analysis populations, endpoint definitions, missing data, multiplicity, subgroup analyses, and sensitivity analyses.

Guide prepared by MODEPHARMA and hosted on the UK Clinical Trials Toolkit to codify good practice on trial supplies and drug management for publicly funded clinical trials. It covers investigational medicinal product (IMP) management across the clinical trial lifecycle, It covers risk‑adapted approaches, common investigational medicinal product (IMP) challenges, trial supplies checklists, legislation, manufacture, stability testing, labelling, imports, pharmacy responsibilities, trial supply costing and frequently asked questions

The Clinical Trials Transformation Initiative (CTTI) brings together regulators, sponsors, investigators, sites and patients to study these problems and turn the findings into practical tools and recommendations that anyone can use. CTTI’s resources cover the full trial lifecycle—from feasibility and start‑up to recruitment, conduct and reporting—with a shared goal: higher‑quality, more efficient and more patient‑centred trials.

The Cochrane Central Register of Controlled Trials (CENTRAL) is a database within the Cochrane Library that provides a highly concentrated source of reports of randomized and quasi‑randomized controlled trials. It contains bibliographic records with citation details and usually an abstract, but not the full text, and is updated monthly. Records are drawn from multiple sources, including PubMed/MEDLINE, Embase, CINAHL, ClinicalTrials.gov, WHO trial registries and Cochrane Review Groups’ specialized registers, and are included regardless of language or publication year. CENTRAL is developed and maintained by Cochrane and is particularly useful for investigators who need to identify controlled trials for inclusion in systematic reviews and evidence syntheses to inform clinical studies.

This article by examines how to finance independent clinical trials of repurposed, mainly off‑patent medicines that industry rarely supports beyond early‑phase studies. Using a literature review and interviews with 16 European experts in clinical research, funding and drug repurposing, it assesses both traditional grants and newer mechanisms such as crowdfunding, public‑private partnerships and social impact bonds as options to fund large phase III trials. The paper is useful for investigator‑initiated clinical studies as it outlines practical opportunities and challenges in using these models to secure sustainable funding for non‑commercial drug repurposing trials.

This EMA guideline provides detailed, practical guidance on how to set up, maintain, secure and archive the trial master file (TMF) in paper, electronic or hybrid form across the whole lifecycle of a clinical trial. It explains the legal and Good Clinical Practice basis for TMF requirements, including the need for essential documents that collectively permit evaluation of trial conduct, participant safety and data integrity, and clarifies that the same basic requirements apply to paper TMFs and eTMFs. The document is aimed at sponsors, investigators/institutions, contract research organisations (CROs), legal representatives and other parties performing sponsor‑trial related duties. The guideline aligns TMF expectations with Directive 2001/20/EC, Directive 2005/28/EC, ICH E6 GCP and Clinical Trials Regulation (EU) No. 536/2014.

European Data Protection Board Guidelines 01/2025 clarify how pseudonymisation should be understood and implemented under the General Data Protection Regulation, explaining its legal definition, risk‑reduction potential, and limits. They guide controllers and processors on when and how to use pseudonymisation to support data minimisation, data protection by design and by default, security of processing, lawful further use and international transfers, while stressing that pseudonymised data remain personal data and must still comply with all General Data Protection Regulation obligations.

ICH E3 is a harmonised tripartite guideline that defines the structure and content of integrated clinical study reports for individual studies of therapeutic, prophylactic or diagnostic agents conducted in patients. It aims to support preparation of a single core clinical study report acceptable to regulatory authorities in Europe, Japan and the United States, with any region‑specific requirements provided as appendices. The guideline sets out a detailed, numbered report structure (sections 1–16 with annexes) covering title page, synopsis, ethics, investigational plan, efficacy and safety evaluation, tables and figures, and appendices including protocol, case report forms, investigator information, patient data listings and statistical documentation. It provides harmonised section headings and example layouts (for example synopsis, study design diagrams, patient disposition and key listings) to promote reports that are complete, unambiguous, well organised and easy to review, and that allow replication of critical analyses by regulatory authorities.

Interactive training and support materials developed under the Accelerating Clinical Trials in the EU (ACT EU) initiative to facilitate implementation of the revised ICH E6(R3) guideline on Good Clinical Practice.
The resource links to ICH-hosted e‑learning modules on foundational concepts, GCP principles and informed consent, alongside a multi‑stakeholder workshop report on ICH E6(R3) principles and Annex 1.
It also provides information on the European applicability date (23 July 2025), and on the public consultation for Annex 2 covering trials with decentralised and pragmatic elements and use of real‑world data.

The International Compilation of Human Research Standards is a global reference, developed by US Department of Health and Human Services, that lists over 1,000 laws, regulations and guidelines (“standards”) protecting research participants in more than 130 countries, plus standards from international and regional organisations. It is organised by world region (including a dedicated Europe section) and, within each country or organisation, classifies information into nine categories: general human subjects research; drugs, biologics and devices; clinical trial registries; research injury; social‑behavioural research; privacy and data protection; human biological materials; genetic research; and embryos, stem cells and cloning. For each category it distinguishes key organisations from relevant standards and, wherever possible, provides web links to the source documents, many available in English or translatable online. First published in 2005, the Compilation focuses specifically on human research protections and is intended for researchers, research ethics committees, sponsors and others overseeing research involving human participants.The website has many more resources that can be interesting for IRB and research community including trainings.

The CTTI Patient Group Engagement Prioritization Tool was developed by the Clinical Trials Transformation Initiative (CTTI) for clinical research sponsors and patient groups to provide a practical framework for planning and prioritising collaboration. It uses a three-step decision-making process (Analyse, Visualize and Collaborate) to help users define expectations, goals, and important roles when working together. It allows users to select collaboration activities that offer the greatest perceived benefit for the lowest required investment, based on a structured assessment of benefits and costs from each partner’s perspective. Partners can map potential engagement opportunities and visualise results in a benefit–investment matrix to inform discussion and decision‑making. The tool can be used for specific clinical trials or broader development programmes to plan patient involvement in design, conduct, and dissemination activities. 
Read more: Perfetto EM, et al. Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development. Ther Innov Regul Sci. 2020. 

The Risk Assessment Form for clinical research projects, developed by the Swiss Clinical Trial Organisation (SCTO), first published in December 2019, is a downloadable, step-by-step form that helps sponsor-investigators assess potential quality risks in clinical research projects in line with ICH GCP E6(R2) requirements and Swiss Human Rights Ordinance (HRO) provisions. Covering both system-level and trial-level risks, it guides users through risk identification, evaluation and mitigation strategy development. It is suitable for both clinical trials and health research projects run, and supports the establishment of a risk-based quality management system. 

This document from the Clinical Trials Coordination Group (CTCG) summarises national fees for clinical trials submitted under the Clinical Trials Regulation in the Clinical Trials Information System (CTIS) for all European Union and European Economic Area member states (a total of 29 countries).  This resource helps sponsors of investigator‑initiated trials to anticipate national costs and plan budgets for multi‑country submissions under the Clinical Trials Regulation. It lists, for each country, the website where official fee information can be found, the type of proof of payment required in CTIS, the expected timing of fee payment in relation to validation and assessment, and whether fee reductions are available for non‑commercial sponsors, low‑interventional trials, lapsed applications, withdrawn applications or other specific situations. The table highlights, for example, countries with zero fees for non‑commercial sponsors, reduced fees or no fees at all.

The European Commission's public registry for clinical trials, through the Clinical Trials Information System (CTIS), plays a central role in disseminating the results of clinical trials by making key trial information publicly accessible throughout the trial lifecycle. CTIS provides a single public portal where patients, healthcare professionals, researchers, and the public can search for information on clinical trials conducted under the EU Clinical Trials Regulation (CTR).
Sponsors are required to submit summary results, including a layperson summary, within specified timelines after the end of a clinical trial. These summaries are published in CTIS, increasing transparency and enabling wider dissemination of findings.

ECRIN clinical research Metadata Repository (crMDR) is a searchable clinical research metadata portal that enables users to identify clinical studies and linked documents, such as protocols, statistical analysis plans and individual participant datasets, from multiple major international sources. It aggregates metadata on clinical research studies and associated data objects, indicating where results and documents are available and how they can be accessed. Researchers can search by study identifier, paper identifier or keywords and then refine results using structured filters on study and data-object attributes. It can support SAP development by providing reusable templates, that can serve as starting points for new studies, reducing the effort required to draft standard sections.
Statisticians can review how similar trials handled analysis populations, endpoint definitions, missing data, multiplicity, subgroup analyses, and sensitivity analyses.
 

Online toolbox developed by the European Clinical Research Infrastructure Network (ECRIN) to support risk‑based monitoring in multinational clinical trials. It provides information on tools used for risk assessment, monitoring and study conduct, including where they are used, links to further information and user feedback. The toolbox was launched at the end of 2015 following a systematic literature review and a survey of clinical trial units (CTUs) that identified existing risk‑adapted monitoring tools, risk evaluation methods and monitoring strategies. It is designed to help researchers, sponsors and non‑commercial investigators select or develop risk‑based monitoring strategies that are appropriate for the specific design, context and resource constraints of their clinical studies.
 

This article from the European Forum for Good Clinical Practice eConsent Initiative introduces the eConsent Fit‑for‑Purpose Study Framework, a stepwise method to design electronic informed consent for each individual study. It explains how to define study‑specific objectives, select the most suitable digital features and operational set‑up, involve key stakeholders, and plan metrics and analysis so that electronic informed consent can be evaluated in a consistent way. The framework is vendor‑neutral and intended for both commercial and non‑commercial sponsors, offering investigator‑initiated studies a practical way to move from technology‑driven decisions to a participant‑ and site‑centred electronic informed consent strategy that generates meaningful, comparable data.

EudraLex Volume 10 is part of “The rules governing medicinal products in the European Union” and brings together the key guidance documents applying to clinical trials on medicinal products for human use. The Volume is structured into six chapters, with distinct document sets for trials conducted under the Clinical Trials Regulation (EU No 536/2014) and for legacy trials under Directive 2001/20/EC. It provides practical regulatory guidance for sponsors, investigators and regulators on clinical trials applications, safety reporting, investigational medicinal product quality, good clinical practice inspections, additional scientific and ethical guidance, and underlying legislation and is a central reference for designing, conducting and reporting clinical trials in line with European regulatory requirements.

Patient Involvement Resource Library (EUPATI Toolbox) – A curated online peer-reviewed library developed by the European Patients’ Academy on Therapeutic Innovation (EUPATI) that compiles publications and resources on patient involvement in health innovation. It supports researchers, patient organisations, and other stakeholders in applying best practices for patient engagement in medicines development, clinical research, HTA, and regulatory processes.

EUPATIConnect is a fee‑for‑service matchmaking platform that connects trained EUPATI Patient Experts with researchers for meaningful patient involvement in medicines research and development. Researchers submit a request describing their project and needs and are matched to patient experts whose profiles, experience and disease areas fit the aims of the collaboration. Engagement can include protocol and document review, advisory boards, focus groups, speaking engagements, co‑creation workshops and other patient engagement activities. The platform is operated by EUPATI, the European Patients’ Academy on Therapeutic Innovation, which coordinates a large network of trained patient experts and national platforms.

Open‑access article in Trials that evaluates how suitable existing data repositories are for hosting individual participant data from clinical studies, from the perspective of clinical researchers. The authors assessed 25 repositories (from an initial 55 identified) using a predefined set of 34 items covering guidance for data upload and de‑identification, data quality controls, contracts, access options, identifiers, metadata and long‑term preservation. None of the repositories fully met all criteria, but three generic repositories (Dryad, DRUM and EASY) fulfilled all indicators fully or partially; most did not charge fees for upload, storage or access. The study highlights wide heterogeneity and information gaps, and offers an evidence‑based starting point for investigators choosing a repository for clinical study datasets.

Good Clinical Laboratory Practice (GCLP) guidelines describe the application of those Good Laboratory Practice principles that are relevant to the analysis of samples from clinical trials while ensuring that the purpose and objectives of Good Clinical Practice are maintained. Hosted by the Global Health Training Centre (The Global Health Network), this free, peer‑reviewed, multi‑module online course provides structured training on implementing GCLP in clinical trial laboratories, with ICH Good Clinical Practice as a prerequisite. It is designed for laboratory professionals and clinical research staff who need to ensure laboratory quality, data integrity and regulatory compliance when handling clinical trial samples, particularly in global health and resource‑limited settings.

The OECD Recommendation on the Governance of Clinical Trials (OECD/LEGAL/0397) is an international framework for proportionate, risk‑based regulation of clinical trials on medicinal products, especially those led by academic and other non‑commercial sponsors. It responds to varying national rules and administrative burdens by introducing stratified risk categories for investigational products (A for authorized products used as licensed, B for authorized products used off‑label, and C for unauthorized products), refined by factors such as product novelty. Using these categories, the Recommendation guides authorities and sponsors to tailor requirements according to trial‑specific risks in three core areas: patient rights, patient physical safety, and data integrity.

ScientifyResearch is an online research funding platform that helps researchers find grants, fellowships and clinical trial funding opportunities worldwide. It aggregates open funding calls from public funders, charitable foundations, disease‑specific organisations, international programmes and industry, offering a single structured entry point to the global research funding landscape. Researchers can explore the database with a free 7‑day trial or subscribe for premium access to advanced discovery and workflow tools, making it a practical resource for planning and financing investigator‑initiated clinical studies.

This ERA4Health resource (prepared in 2024) is a concise inventory of funding mechanisms that can support multinational, non commercial investigator‑initiated clinical studies in Europe. It compiles European, national and transnational programmes that fund non‑commercial multi‑country research across the clinical spectrum, from early‑phase and proof‑of‑concept work to large pragmatic, comparative‑effectiveness and drug‑repurposing trials. The document explains why such studies are essential for patient-centered, affordable and practice changing evidence, and describes the main funding gaps and administrative barriers that currently limit cross border trials in the EU. Funding schemes are organised by funder type and intervention and each entry summarises scope, eligible study types, geographic reach and key operational features relevant for multinational studies.

Online tutorial from the European Patients’ Academy on Therapeutic Innovation (EUPATI) that explains how clinical trial results are recorded and reported once a study has finished. It introduces the clinical study report format and the main routes used to disseminate trial findings, including regulatory documents, trial registries, scientific journals, conferences, patient organisation websites and news media. A downloadable presentation is provided for reuse in training and education.
 

EUREC (European Network of Research Ethics Committees) is a pan-European umbrella network connecting national Research Ethics Committee (REC) associations and research ethics experts across Europe. Founded in 2005, it provides country-specific information on REC systems, resources for REC members, and supports capacity building. For investigators, it is the key reference for identifying the ethical review framework and relevant committees in each participating European country.

Good Clinical Laboratory Practice (GCLP) is guidance developed by the British Association of Research Quality Assurance and published by the Special Programme for Research and Training in Tropical Diseases (TDR), sponsored by UNICEF, UNDP, the World Bank and WHO, to define standards for laboratories analysing clinical trial samples. It identifies the systems, facilities and procedures required to apply Good Laboratory Practice principles to the analysis of clinical trial samples while maintaining the objectives of Good Clinical Practice, and provides sponsors, laboratory management, project managers, clinical research associates and quality assurance personnel with a framework for a laboratory quality system that supports reliable, ethical clinical trial data.

This EMA methodological guideline for first‑in‑human (FIH) and early‑phase trial design and risk mitigation (EMEA/CHMP/SWP/28367/07 Rev. 1) provides detailed strategies to identify and manage risks in early clinical trials with investigational medicinal products (IMPs). It updates and extends earlier EU guidance to cover the transition from non‑clinical studies to FIH and early‑phase trials, including starting‑dose calculation using the no‑observed‑adverse‑effect level (NOAEL) and minimal anticipated biological effect level (MABEL), principles for dose escalation and maximum exposure, integrated protocols combining single ascending dose (SAD), multiple ascending dose (MAD) and other study parts, trial‑stopping rules, and expectations for monitoring and communication with regulators.

ICH Good Clinical Practice E6(R3) is a free online training course from The Global Health Network’s Global Health Training Centre, updated to reflect the latest ICH E6(R3) Good Clinical Practice guideline. It consists of eight short modules (around 180 minutes in total) that explain GCP principles and their practical application throughout the clinical research process, with a focus on protecting participants and ensuring data integrity and validity. The course is suitable for all members of the clinical research team, including those working in diverse and resource‑limited settings, and provides a certificate on successful completion of the final assessment.

Harmonised ICH guideline on the Development Safety Update Report (DSUR), adopted at Step 4 on 17 August 2010. The DSUR is defined as the common standard for annual periodic safety reporting on drugs under development, including marketed drugs that remain under clinical investigation, across ICH regions. The guideline specifies the objectives, scope, content, format, periodicity and submission timelines of DSURs, and outlines sponsor responsibilities for their preparation.

The Patient Engagement Resource Centre (PERC) is a European online hub that helps researchers incorporate meaningful patient and public involvement into biomedical and clinical studies, including investigator‑initiated trials. It brings together curated, publicly available guidance, tools, templates and training materials produced by established patient and research organisations. Users can search resources across four categories: fundamental topics, and the research phases of planning, conduct and follow‑up. Each section clearly distinguishes high‑level guidance from ready‑to‑use tools and templates that can be adapted to different research projects.

Open‑access consensus article in BMJ Open that sets out principles and practical recommendations for sharing and reuse of individual participant data from clinical trials. Developed by a multistakeholder European task force led by the European Clinical Research Infrastructure Network as part of Horizon 2020 CORBEL project, it focuses mainly on non‑commercial trials and examines key issues such as consent for data sharing, protection of trial participants, data standards, access models, repositories and metadata. The paper presents 10 overarching principles and 50 recommendations intended to guide ethics‑compliant, high‑quality individual participant data sharing in clinical research.

The Health NCP Net 3.0 'Find open calls' tool provides an up-to-date, filterable overview of health-related funding opportunities across Horizon Europe Cluster 1 – Health and linked European programmes. Developed by the Health NCP Net 3.0 project — a Horizon Europe-funded initiative aligning services of national contact points — it aggregates open, forthcoming and closed calls with direct links to official documentation. Research teams planning investigator-initiated clinical studies can use it to scan European funding landscapes and match emerging study ideas to relevant calls and submission deadlines.

The Cambridge Clinical Trials Unit (CCTU) has made available its quality management documentation - including standard operating procedures, policies, and templates - covering the full lifecycle of sponsored clinical trials. Freely accessible on the CCTU governance page, these materials serve as practical reference documents for investigator‑led clinical research teams and span all trial phases: pre‑trial (planning, protocol development, set‑up), conduct (trial documentation, pharmacovigilance, data management, and statistics), and post‑study (close‑down, post‑study procedures, and archiving).

The CTR Classification Guide is a free European online clinical trial decision tool developed by Paul Janssen Futurelab Leiden and the Dutch Central Committee on Research Involving Human Subjects (CCMO). It helps investigators determine whether a planned study with medicinal products falls within the scope of the EU Clinical Trials Regulation (CTR 536/2014), whether it qualifies as a low‑intervention clinical trial, or whether it lies outside the CTR framework. Through a structured series of questions, the tool clarifies whether a study is considered a clinical trial of medicinal products in the European Union/European Economic Area and indicates when adapted rules for low‑intervention trials may apply. Investigators can use the guide early in study planning to identify the applicable regulatory pathway and to prepare appropriate submissions to ethics committees and competent authorities.

The resource is a 14‑page recommendations document issued in April 2017 by the European Commission expert group on clinical trials to support implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. It sets out how to apply risk‑proportionate approaches to the design, conduct and oversight of clinical trials, so that trial requirements are adapted to the actual risks to participants, trial integrity and data reliability, rather than following a “one size fits all” model. The guidance explains risk‑based quality management principles and describes how risk assessment and mitigation can inform monitoring, safety reporting, investigational medicinal product handling and trial documentation, including the Trial Master File.

The European Medicines Agency maintains an online list of national competent authorities responsible for human medicines in each European Union and European Economic Area Member State. The national competent authorities are primarily responsible for the authorisation of medicines available in the EU that do not fall under the scope of the centralised procedure. This directory is part of the European medicines regulatory network information and is regularly updated. Investigators and sponsors planning clinical trials or other regulatory activities in one or more European countries can use it to quickly identify and contact the relevant national competent authority for clinical trial authorisations and other regulatory queries.
 

EudraLex Volume 4 contains the EU Guidelines to Good Manufacturing Practice (GMP) for medicinal products for human and veterinary use, setting out the detailed GMP principles manufacturers must meet in manufacture and control. It includes Annex 13 on investigational medicinal products (IMPs), which covers manufacture, packaging, labelling and quality control of IMPs used in clinical trials, and forms a key regulatory reference for sponsors and investigators. The European Medicines Agency coordinates GMP inspections and related activities at European level, in line with these guidelines. Until 15 July 2026 the guidelines apply to both human and veterinary medicinal products; from 16 July 2026 specific implementing regulations will apply for veterinary medicinal products and their active substances, while remaining aligned with the GMP framework for human use.

Developed by the European Clinical Research Infrastructure Network (ECRIN) within the ERA4Health Partnership, the document shares pratical guidance on how to prepare data sharing plans for clinical studies, and how to design General Data Protection Regulation (GDPR)‑compliant strategies for sharing Individual Patient Data (IPD), including informed consent for secondary use and long‑term storage in repositories that follow FAIR (Findable, Accessible, Interoperable and Reusable) principles. It aligns data sharing planning with expectations from European and international funders and is aimed at investigators, funders, research staff and other stakeholders involved in investigator‑initiated clinical trials.

The ICH E9 (R1) addendum “Estimands and Sensitivity Analysis in Clinical Trials” (EMA/CHMP/ICH/436221/2017) was adopted by the ICH Assembly at Step 4 on 20 November 2019 and came into effect in the European Union on 30 July 2020. It introduces a structured framework to align clinical trial objectives, design, conduct, analysis and interpretation through the explicit definition of estimands: precise descriptions of the treatment effect that reflect how intercurrent events such as treatment discontinuation, rescue medication or death are handled. The addendum describes five main strategies for addressing intercurrent events (treatment policy, hypothetical, composite, while‑on‑treatment and principal stratum) and explains how these choices influence trial design, data collection and analysis. It clarifies the role of sensitivity analysis, which must target the same estimand as the main estimator and is used to assess the robustness of conclusions to deviations from modelling assumptions and data limitations. The principle is that trial protocols should pre‑specify primary and key secondary estimands, aligned estimators and planned sensitivity analyses so that regulators, sponsors and investigators have a shared understanding of what treatment effect is being estimated and how reliable the resulting evidence is for decision making.

This free, self‑paced online course provides a general introduction to adverse events in clinical research and how to manage them when they occur. It explains why adverse events should be collected, how they are defined and categorised, and what information needs to be documented and reported. The course outlines mechanisms for detecting adverse events, evaluating their seriousness and relatedness to the study intervention, and planning appropriate follow‑up. It also summarises what data are typically included in adverse event reports and who should receive them. The training is suitable for all members of a clinical research team, including those new to safety reporting in investigator‑initiated studies.

This reflection paper from EMA adopted by GCP Inspectors Working Group in February 2012, provides guidance for laboratories that perform analyse or evaluate human samples collected in clinical trials, to help them establish and maintain quality systems that comply with European directives, national regulations and associated guidance. It also sets out what good clinical practice inspectors expect when they inspect laboratories performing work in support of human clinical trials, including investigator‑initiated studies.

Guidance from the European Commission on preparing summaries of clinical trial results for laypersons, in line with Clinical Trials Regulation (EU) No. 536/2014. Good Lay Summary Practice (GLSP) provides recommendations on planning, writing, translating and disseminating plain‑language summaries of clinical trial results, covering all ten mandatory lay summary content elements specified in Annex V of the Regulation. It aims to support transparent, understandable communication of trial outcomes to participants and the public. GLSP is mandatory guidance for interventional clinical trials with medicinal products conducted in the EU/EEA and published in EudraLex Volume 10.

Cochrane PICO search is a powerful discovery tool for finding Cochrane Reviews. Clinical trials start with a clearly defined research question. The PICO framework, which underpins the PICO search tool, is widely used to structure clinical research questions. PICO search allows researchers to use these PICO terms to find the Cochrane Reviews most relevant to their healthcare question. 

Guideline from the European Medicines Agency on the use of computerised systems and electronic data in clinical trials (EMA/INS/GCP/112288/2023). It sets principles and requirements for instruments, software and “as a service” solutions used to create, capture, process, store and archive electronic clinical data across the full data life cycle. Topics include data integrity and ALCOA++ principles, roles and responsibilities, system validation, user management, security, audit trails, electronic signatures, data protection, cloud solutions and database decommissioning. It applies to systems such as electronic medical records, electronic case report forms, electronic clinical outcome assessment and patient‑reported outcome tools, wearables, interactive response technologies, electronic informed consent, electronic trial master files, clinical trial management systems, pharmacovigilance databases and artificial intelligence‑based tools, and replaces the 2010 Reflection Paper on electronic source data.

The ICH E9 guideline “Statistical Principles for Clinical Trials” is a harmonised tripartite guideline, adopted at Step 4 on 5 February 1998, for marketing applications in Europe, Japan and the United States. It gives direction to sponsors on the design, conduct, analysis and evaluation of clinical trials of an investigational product within its overall clinical development, and supports experts preparing application summaries or assessing evidence of efficacy and safety, mainly from later‑phase confirmatory trials. It sets out core statistical principles for minimising bias and maximising precision, without prescribing specific methods, and assumes that an appropriately qualified statistician is responsible for implementing these principles.
 

The NCCIH Clinical Research Toolbox is a web‑based information repository for investigators and staff involved in NCCIH‑funded clinical research. Developed by the National Center for Complementary and Integrative Health (US NIH), it brings together required templates, sample forms, FAQs, policies and guidance to support the development and conduct of high‑quality clinical research studies. Content is organised into sections such as clinical research start‑up, documents used during study conduct, on‑site monitoring, milestone documents and additional training and recruitment resources, making it a practical reference point for investigator‑initiated trials. Although some elements are specific to the NCCIH research, many sections on trial planning and development are also relevant to European researchers conducting investigator‑initiated studies.