The Regulatory and Ethical Database (RED) is a regularly updated, online search tool that provides country‑specific information on regulatory and ethical requirements for clinical research across Europe. Developed by the European Clinical Research Infrastructure Network (ECRIN), it offers structured, up‑to‑date content on national legislation, competent authorities, ethics committees and study‑specific provisions for medicinal products, medical devices and other clinical studies. RED is designed to support investigators and sponsors in planning, initiating and conducting mono‑ and multinational clinical studies by providing simple, centralised access to key submission and compliance information by country and study type. It also provides regulatory and ethical information for specific population groups, such as minors, incapacitated persons, emergency situations and pregnant or breastfeeding women. For researchers looking to expand a study to another country, a “Compare” feature enables side‑by‑side review of legislation and other requirements for clinical research in two selected countries.

TranspariMED’s Clinical trial transparency tools page collates practical tools, manuals, workshop materials and case studies that universities and other institutions can use to strengthen clinical trial registration and results reporting, improve registry data quality, and embed transparency within institutional policies and audit practices.

Downloadable guidance document published by the World Health Organization (WHO) that sets out best practices for the design, conduct, registration, oversight and reporting of clinical trials globally. It responds to the World Health Assembly resolution WHA75.8 on strengthening clinical trials, updating earlier WHO work on research capacity for the context of well‑designed and well‑implemented trials. The guidance aims to enhance clinical research efficiency, minimise research waste and support sustainable clinical trial capacity that can function in routine settings and pivot during health emergencies. 

COBWEB (CONSORT‑based WEB tool) is a user friendly online manuscript‑writing aid that guides authors through drafting randomised controlled trial reports in line with the Consolidated Standards of Reporting Trials (CONSORT) and its extensions. Developed by clinical epidemiologists, it helps users write, edit, share and export randomised trial manuscripts structured around CONSORT checklist items. The tool provides tailored templates for different trial designs and intervention types, with bullet‑point prompts and examples of good reporting for each item, consolidating relevant CONSORT guidance into a single, editable document.

ICH E6 (R3) is the current International Council for Harmonisation guideline on Good Clinical Practice, adopted by the European Medicines Agency as a scientific guideline with effect from 23 July 2025. It sets international standards for the design, conduct, recording and reporting of clinical trials involving human subjects, to support the mutual acceptance of clinical trial results by regulatory authorities across ICH member regions It outlines the responsibilities of sponsors, investigators, and other stakeholders to protect the rights, safety, and well-being of trial participants, while ensuring the integrity and credibility of clinical trial data. The guideline is structured as:

• Overarching principles and objectives document;
• Annex 1 focused on interventional clinical trials;
• Annex 2 to address additional Good Clinical Practice considerations for certain non‑traditional interventional trials (pragmatic clinical trials, decentralised clinical trials, trials that incorporate real-world data sources). 

Foundational ICH harmonised guideline on clinical safety data management, adopted at Step 4 on 27 October 1994 and intended for use alongside other Good Clinical Practice guidelines. It defines key terms such as adverse event, adverse drug reaction, serious adverse event and unexpected adverse reaction, and clarifies the distinction between serious and severe events. The guideline sets internationally agreed standards for expedited reporting of serious and unexpected adverse drug reactions in the pre‑approval phase, including reporting time frames and minimum criteria for case reporting. It is an essential reference for clinical trial sponsors and investigators developing safety reporting procedures and regulatory submissions in line with ICH E2A requirements.

This document is a mapping and forward-looking overview of all scientific/regulatory advice mechanisms in the EU medicines system, with a strong focus on coordination, early engagement, and support for better clinical development. The document is essentially a framework overview. It explains what advice exists, how to access it and how the system is evolving.

This MedEthicsEU overview, written and endorsed by a group of national representatives of Medical Research Ethics Committees in EU/EEA member states, summarises Part II clinical trial application requirements per country under the Clinical Trials Regulation (EU) No 536/2014. Version 3.0 (14 March 2025) covers 21 member states and supersedes version 2.0. It is a practical European reference for sponsors compiling country‑specific Part II documentation for multi‑country clinical trial applications in CTIS. For each country it lists, for every Clinical Trials Information System Part II placeholder, which documents are required, whether European Commission or national templates are mandatory or recommended, the legal basis (Regulation, national law, guidelines or other) and links to ethics committee or authority websites. The document is described as a living, non‑binding tool to facilitate submission of clinical trial applications and should be read together with the Clinical Trials Regulation and EudraLex Volume 10 templates.

An online research data management guide maintained by University College London (UCL) Library Services, covering how to manage the outputs of research projects across the full data lifecycle. It supports researchers from planning to project closure, including writing a data management plan, organising and storing data securely during a study, and choosing where and how to share or preserve data at the end. The guide addresses key issues such as data protection, copyright, long‑term preservation, and compliance with institutional and funder expectations. Relevant for clinical investigators who need to handle research data systematically, protect participants’ information, and meet open research and data sharing requirements.

The Easy Guide to Clinical Studies (Easy GCS) is an online tool developed by the Swiss Clinical Trial Organisation (SCTO) Project Management Platform, with input from all SCTO platforms and the Swiss Biobanking Platform. It provides easily accessible, phase‑specific guidance for planning and conducting clinical studies, organised in a grid that combines six study phases with key subjects such as protocol, ethics and laws, study management, safety, data management, statistics, quality and risk, monitoring, and biobanking. Each cell links to topic pages that answer three practical questions: what the topic is and why it matters, what needs to be done, and where to get help. The tool is aimed at sponsor‑investigators, site investigators, research coordinators and other clinical research professionals, and supports investigator‑initiated studies in Switzerland and beyond by clarifying regulatory requirements and operational good practice from study concept through to completion

This EudraLex Volume 10 page, published by the European Commission, provides the official clinical trial application templates for preparation of Part I and Part II documentation for the Clinical Trials Information System (CTIS) under Regulation (EU) No 536/2014 in European Union and European Economic Area member states. It includes document templates for the CTIS form section (statement on compliance with Regulation (EU) 2016/679 on data protection) and Part II application documents, such as compensation for trial participants, investigator curriculum vitae, declaration of interest, site suitability form, informed consent and patient recruitment procedure, and compliance with rules for biological samples. Templates are available in portable 
document format (PDF) and Word format for direct use or adaptation by sponsors.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) can issue qualification opinions or qualification advice on novel methodologies used in medicine development, such as biomarkers, imaging methods and digital tools, within a defined context of use in non‑clinical or clinical studies. 

A web‑based research data management toolkit for life sciences, developed and maintained by the ELIXIR network. It guides researchers and data stewards in managing research data across the full data lifecycle in line with FAIR (Findable, Accessible, Interoperable, Reusable) principles. Content is community‑driven, with contributors from many European countries, and focuses on practical, domain‑specific and role‑based guidance. Particularly relevant for biological and health research, including investigator‑initiated clinical studies that need to ensure that data are well documented, reusable and compliant with funder expectations.

Clinical Trials Regulation (EU) No 536/2014 in practice” is a quick guide produced under EudraLex Volume 10 to help sponsors to apply the Clinical Trials Regulation (EU) No 536/2014 in the European Union and European Economic Area. Prepared by the Clinical Trials Coordination and Advisory Group (CTAG), whose members are the National Contact Points named in the Regulation, it provides a practical overview of the main rules and procedures, to be read alongside the legislative text. The guide outlines key principles of the Clinical Trials Regulation, the transition period and step‑by‑step processes before, during and after a clinical trial, including use of the Clinical Trials Information System (CTIS), safety reporting, transparency, and specific requirements for advanced therapy and genetically modified investigational medicinal products. It is intended to facilitate day‑to‑day implementation of the Regulation for national and multinational clinical trials.

The Protocol Development Toolkit, part of the EDCTP Knowledge Hub, is an online resource developed by the European & Developing Countries Clinical Trials Partnership (EDCTP) and The Global Health Network to support high‑quality health research protocols, particularly for clinical studies in low‑resource settings. It combines step‑by‑step guidance on protocol development with examples, templates and interactive tools, including the Concept Protocol Crowd Review Tool, the SEPTRE electronic protocol builder and the Study Walk‑through toolkit. Linked training materials cover scientific, ethical, regulatory, operational and data‑management aspects of study design, helping investigator‑initiated studies move from a research question to a complete, robust protocol.

The CONSORT-Outcomes 2022 extension provides harmonised, evidence‑ and consensus‑based guidance for reporting outcomes in randomised clinical trial reports, adding 17 outcome‑specific items to the CONSORT 2010 (and updated CONSORT 2025) checklist to ensure that outcomes are fully defined, justified, assessed, analysed and reported in ways that enhance trial utility, replicability and transparency, and limit selective non‑reporting of trial results.

Hosted by Trial Forge, this online library provides real‑world Participant Information Leaflets (PILs) and Informed Consent Forms (ICFs) used in randomised trials, assembled through the EXCELSIOR project. The collection allows researchers to see how key trial concepts such as randomisation, placebo use and withdrawal rights are actually explained to potential participants in practice. Investigators can review and compare wording across trials and use these examples to inform the design of their own participant information leaflets and consent forms for future studies.

A harmonised European template for agreements between trial sponsors and clinical sites that facilitates the setup of multi-country clinical trials. It standardizes key contractual provisions, reduces negotiation time and administrative burden, supports compliance with ICH Good Clinical Practice, and promotes efficient collaboration across participating sites. It is particularly useful during the trial initiation and site activation stages of clinical trial management. Developed by ECRIN within the ERA4Health project, its primary objective is to streamline and standardize contractual negotiations between trial sponsors and participating clinical sites while accommodating national legal requirements.

CONSORT 2025 is the updated Consolidated Standards of Reporting Trials statement, providing a 30‑item checklist and participant flow diagram that set out the minimum information required when reporting randomised trials. It supersedes earlier CONSORT versions (1996, 2001, 2010) and reflects new methodological evidence, open science practices and user feedback. Developed through a scoping review, international Delphi survey (317 participants in round 1) and expert consensus meeting, it aims to improve clarity, completeness and transparency of trial reports. The guideline is endorsed by major journals and editorial organisations and is associated with more complete reporting in journals that require its use. Authors, editors, reviewers and other users are encouraged to use CONSORT 2025 alongside the detailed explanation and elaboration document and expanded checklist when preparing or appraising reports of randomised trials.

An online Data Sharing Toolkit, developed within the EDCTP Knowledge Hub and hosted by The Global Health Network, that collates practical information and resources on sharing clinical and health research data. It brings together guidance on data management basics, step‑by‑step data sharing workflows and a repository finder tool to support researchers in preparing, documenting and depositing datasets in appropriate repositories. 

Regulation (EU) No 536/2014 is the core European legislative act governing clinical trials on medicinal products for human use. It repeals Directive 2001/20/EC and sets directly applicable, uniform rules for the authorisation, conduct and supervision of clinical trials in all Member States, with specific provisions on low‑intervention clinical trials. It is the primary legal reference for sponsors and investigators planning or conducting clinical trials with medicinal products in Europe.The Regulation aims to ensure that the rights, safety, dignity and well‑being of trial subjects are protected and that data generated in clinical trials are reliable and robust, while enabling efficient authorisation procedures, including for multinational trials.

Produced within the EU‑funded i‑CONSENT project (H2020, Grant Agreement 741856), these guidelines provide evidence‑based recommendations for designing, tailoring and reviewing the informed consent process in clinical studies with human participants. They present consent as a continuous, participant‑centred communication process rather than a one‑off signature, helping investigators move beyond standard form‑based approaches towards ethically robust procedures aligned with EU regulations and international guidance. The document offers ready‑to‑adapt checklists, fact sheets and practical tools that can be built into study protocols, investigator training and ethics committee submissions, with particular attention to vulnerable and under‑represented groups. It supports the development of consent strategies that improve participant understanding, foster trust and enable genuinely informed, autonomous decisions in investigator‑initiated research.

The Patient Engagement Toolbox, developed under the IMI‑PARADIGM (Innovative Medicines Initiative – Patients Active in Research and Dialogues for an Improved Generation of Medicines) project, centralises co‑created recommendations, practical tools and background materials to make patient engagement in medicines development easier, more consistent and more impactful. The toolbox is organised around three key phases of patient engagement: planning, conduct, reporting and evaluation. 

World Health Organization policy and implementation guidance on the sharing and reuse of health‑related data for research purposes. It clarifies how health data collected under the auspices of WHO technical programmes may be reused and onward shared for research, in both emergency and non‑emergency situations. The policy covers research data generated directly by WHO, research funded by WHO and the reuse of other health‑related data for research when WHO is involved. It sets objectives and principles for data sharing that are equitable, ethical, efficient and consistent with FAIR (Findable, Accessible, Interoperable, Reusable) data practices, and is accompanied by implementation guidance to support the development of data management and data sharing plans for each dataset for which WHO is responsible.

ECRIN’s Data Centre Certification Programme identifies non‑commercial clinical trials units that can demonstrate safe, secure, compliant and efficient management of clinical research data. The programme is built on a published set of data centre standards that cover information technology infrastructure, data management processes, treatment allocation and statistical programming. These standards are used both for independent on‑site audits and as a practical reference for good clinical data management practice.

Endorsed by the EU Clinical Trials Coordination and Advisory Group (CTAG), this European Commission template supports sponsors and investigators in describing recruitment arrangements and informed consent procedures for clinical trials under Regulation (EU) No 536/2014. It is not mandatory, but if it is not used, all items it covers must still be addressed in the protocol as a minimum. The template guides users through how potential participants are identified and approached, how consent is obtained and documented, and how special situations such as incapacitated adults, minors, emergency research and cluster trials are handled. It is most useful for EU/EEA trials needing a structured, regulator‑aligned description of recruitment and informed consent arrangements, including investigator‑initiated CTIMPs.

This document is a mapping and forward-looking overview of all scientific/regulatory advice mechanisms in the EU medicines system, with a strong focus on coordination, early engagement, and support for better clinical development.The document is essentially a framework overview. It explains what advice exists, how to access it and how the system is evolving.

The Adaptive Platform Trial Toolbox is an online resource developed by ECRIN, European Clinical Research Infrastructure Network, and partners within EU‑funded projects such as RECOVER and EU‑RESPONSE. It collates accumulated knowledge, experience and resources from multiple adaptive platform trials into a practical, guided toolbox to support the planning and conduct of future adaptive platform trials in any therapeutic area. More than 130 tools are organised into categories and subcategories, each with a short description of format and level of validation, helping researchers and sponsors quickly find relevant guidance, templates and examples for complex platform trial designs.

EU‑X‑CT initiative aims to improve safe and equitable access to clinical trials in Europe when suitable options are not available in a patient’s home country. The document shares practical approaches to cross‑border recruitment, conduct and follow‑up and is linked to the wider EU‑X‑CT online resources for patients, caregivers and clinical trial professionals, including a trial preparator and country profiles for selected European states.The initiative has developed general recommendations on key aspects of clinical trial management and conduct to address the challenges faced by participants who travel across borders to join a study. These recommendations were developed through a multi‑stakeholder process coordinated by the European Forum for Good Clinical Practice (EFGCP) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

This ERA4Health report  presents a structured mapping of organisations that can support at national or international level the planning, design, and conduct of multicountry Investigator Initiated Clinical Studies (IICS) in Europe. It compiles information on the services offered by clinical trial units (CTUs), academic clinical research centres, national coordinating centres, disease‑specific networks, and other non‑commercial infrastructures that provide services for investigator‑led clinical trials. For each organisation, the report documents core competencies, target trial phases, therapeutic focus (where applicable), geographic scope, and experience with multinational trials.

The SPIRIT‑Outcomes 2022 extension to the SPIRIT 2013 statement is an international, evidence‑ and consensus‑based guideline that specifies 9 outcome‑specific items to be addressed in all clinical trial protocols. Developed within the InsPECT project using the EQUATOR framework, it supplements the SPIRIT 2013 checklist with minimum essential standards for defining, justifying, measuring, and analyzing trial outcomes. Applying SPIRIT‑Outcomes can enhance trial utility, reproducibility, and transparency and may help reduce selective nonreporting of trial results, making it particularly valuable for investigator‑initiated clinical studies.

The COSMIN database of systematic reviews of outcome measurement instruments is an online, searchable collection of systematic reviews that evaluate the quality of health‑related outcome measures in humans. It is developed by the international COSMIN (COnsensus‑based Standards for the selection of health Measurement INstruments) initiative to support research and clinical practice. The database helps investigators identify existing systematic reviews on patient‑reported outcomes and other measurement instruments, see which tools have evidence on reliability, validity and responsiveness, and spot gaps in the evidence. This makes it a useful starting point when selecting and justifying outcome measurement instruments in investigator‑initiated clinical studies.

PANDA (Practical Adaptive & Novel Designs and Analysis toolkit) is an open‑access, online educational resource developed by the University of Sheffield and collaborators to support researchers in using adaptive designs, their practical application, potential benefits and limitations. Aimed at trialists across disciplines, it explains when and how to use key adaptive approaches—sample size re‑estimation, group sequential, multi‑arm multi‑stage, adaptive population enrichment and response adaptive randomisation—and outlines their practical, statistical and operational implications. It is particularly relevant for statisticians, clinicians, trial managers, data managers and grant developers working on complex or innovative trial designs.

Trials@Home is a public–private partnership funded by the Innovative Medicines Initiative that has developed recommendations for decentralised clinical trial approachesl.The consortium explored how to move trial activities from traditional sites to the participant’s immediate surroundings using digital and operational innovations. Investigator‑initiated studies can use these recommendations to design, implement and evaluate decentralised or hybrid trials, improve participant accessibility and retention, and ensure appropriate oversight, data protection and site support. Its main and in‑depth recommendations cover methodological, regulatory, ethical, operational and social aspects of decentralised clinical trials.

The SPIRIT‑Outcomes 2022 extension to the SPIRIT 2013 statement is an international, evidence‑ and consensus‑based guideline that specifies 9 outcome‑specific items to be addressed in all clinical trial protocols. Together, these two guidelines create a clear reporting continuum from the trial protocol to the final trial report, helping researchers prepare protocols and reports more consistently and making it easier to assess adherence to the planned protocol. It supplements the SPIRIT 2013 checklist with minimum essential standards for defining, justifying, measuring, and analyzing trial outcomes. Applying SPIRIT‑Outcomes can enhance trial utility, reproducibility, and transparency and may help reduce selective nonreporting of trial results.

This recommendation paper provides harmonised guidance on introducing decentralised elements into clinical trials with investigational medicinal products in the EU/EEA, beyond any specific health‑crisis context. Developed under the Accelerating Clinical Trials in Europe (ACT EU) initiative by the Heads of Medicines Agencies Clinical Trials Coordination Group (HMA CTCG), the European Commission Clinical Trial Expert Group (CTEG) and the European Medicines Agency Good Clinical Practice Inspectors Working Group (EMA GCP IWG), it reflects the common view of the European medicines regulatory network but is not legally binding. The document includes investigator oversight, informed consent (including electronic methods), delivery and home administration of investigational medicinal products, trial‑related procedures at home, data collection and management, and trial monitoring in decentralised settings, supported by an appendix with an overview of national provisions per EU Member State. Investigator‑initiated and academically sponsored trials can use this paper to plan and document risk‑proportionate decentralised or hybrid designs while protecting participants and ensuring robust data.

Hosted by the Global Health Trials Knowledge Hub (TGHN), this open-access library provides over 100 ready-to-use templates and tools spanning the full clinical trial lifecycle. Categories cover protocol development, participant enrolment and retention, informed consent, IMP management, data management, site management, ethics, safety reporting, staff management, and quality assurance. Designed primarily for trials in global health settings, templates are directly adaptable for investigator-led studies.

This ICH guideline (2017) outlines principles for planning multi-regional clinical trials (MRCTs) to support global regulatory acceptance by evaluating treatment effects and safety across populations. It provides a framework for designing trials that generate evidence acceptable to multiple regulators and facilitate efficient global drug development, including single multinational trials for rare diseases.

The COMET (Core Outcome Measures in Effectiveness Trials) Initiative brings together people interested in developing and applying agreed standardised sets of outcomes, known as core outcome sets (COS). These represent the minimum that should be measured and reported in all clinical trials of a specific condition, and can also be used in routine care, clinical audit and other types of research. COMET provides an international hub and searchable database of COS‑related studies, along with methodological resources to support their development and use in clinical research.

This guidance provides an overview of the scientific and regulatory support mechanisms available through the European Medicines Agency (EMA) and national competent authorities to assist medicine developers throughout the development process. It helps investigators identify the most appropriate regulatory interactions during protocol development, including innovation meetings, scientific advice, protocol assistance and qualification procedures. The resource is particularly relevant for rare disease clinical trials, where early regulatory engagement can support innovative study designs, small population methodologies and efficient protocol development.

This EMA guidance (2025) explains to users, in the form of FAQs how to request EMA scientific advice and protocol assistance, outlining the procedures, scope, and nature of these services so that applications can be prepared, validated, and evaluated efficiently. Applicants are guided through the different steps of the procedure and receive useful information on how to prepare a possible discussion meeting with the Scientific Advice Working Party (SAWP).

SPIRIT and SPIRIT extensions are internationally endorsed reporting guidelines for clinical trials that support protocol development and trial reporting across the full research lifecycle. CONSORT 2025 provides a 30-item checklist for reporting randomized trial results, including title and abstract, trial registration, protocol and statistical analysis plan, participant flow, recruitment, harms, outcomes, interpretation, limitations, and other open science elements.  

The website hosts two online tools: SEPTRE and COBWEB:

• SEPTRE: the SPIRIT Electronic Protocol Tool & Resource, is an online trial protocol writing and management tool that helps users create, register, and manage protocols in line with SPIRIT guidance.
• COBWEB: the CONSORT-based WEB tool, is an online manuscript writing aid that guides authors through structured templates to write, edit, share, and export randomised trial reports in line with CONSORT and its extensions.

The UKTMN Guide to Efficient Trial Management is a practitioner‑written reference for those involved in managing non‑commercial, academically initiated clinical trials in the UK. Hosted by the Nottingham Clinical Trials Unit, University of Nottingham, and overseen by the UK Trial Managers’ Network Editorial Board, it describes the process of understanding and managing randomised trials and outlines the trial management framework, both legal and operational, providing pragmatic advice, hints, tips and links to external resources. It is written primarily for new trial managers as an essential reference tool, and also serves as an aide‑mémoire and induction resource for more experienced staff. Although some elements are specific to the UK national infrastructure, many sections on trial planning and development are also relevant to European researchers conducting investigator‑initiated studies.

Developed by the Good Clinical Trials Collaborative (GCTC), this guidance sets out the underpinning principles of good randomised controlled trials (RCT): reliably informative, ethical, and efficient. It  is organised around five guiding principles with detailed sub‑principles that cover design, conduct, oversight, and reporting. The guidance is accompanied by a structured evaluation tool to help users reflect on how well their trials align with these principles in their specific context. An online learning course further explores the fundamental principles of what makes a good trial and supports all those involved in planning, conducting, regulating, funding, or using the results of randomised trials to apply the guidance in practice.

Developed by the ICH Expert Working Group, the ICH E8 (R1) Guideline is an internationally recognized guidance document from the  that defines core principles and general considerations for designing and conducting clinical studies, including exploratory and confirmatory trials. It provides a broad framework for trial planning, quality‑by‑design, risk‑based approaches, ethical considerations, statistical thinking, and meaningful interpretation of study outcomes.