Guidelines and Recommendations

Please note: We have compiled and checked the listed content with care. However, we cannot guarantee that it is complete or up-to-date, and the addresses of the listed links may change. We are not responsible for external content to which we refer. Please inform yourself about the documents relevant to you.

• University of Cologne: Scientific principles
• University of Cologne: Safeguarding Good Scientific Practice
• University of Cologne: Research Data Management
• University of Cologne: Guideline on the Handling of Research Data
• Medical Faculty of the University of Cologne
• Ethics Commission of Cologne University’s Faculty of Medicine
• Data Protection Officer of the University of Cologne
• ZKS/CTCC Clinical Trials Centre Cologne
• Animal Welfare Officer of the University of Cologne
• University Hospital Cologne (internal / external)

• Declaration of Helsinki: on the website of theWorld Medical Association
• ICH: The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
• ICH Guidelines: Quality, Safety, Efficacy and Multidisciplinary Guidelines
• ICH-E 6: Guideline for Good Clinical Practices (GCP)
• ICH-E 9: Note for Guidance on Statistical Principles for Clinical Trials
• ICH-E 10: Choice of Control Group and Related Issues in Clinical Trials
• GEP : Guidelines and Recommendations for Safeguarding Good Epidemiologic Practice (GEP) - revised version after evaluation
• GEP: Guidelines and Recommendations for Safeguarding Good Epidemiologic Practice on the website of the German Society for Epidemiology (DGEpi) e. V.
• GEP: Current version of the Good Epidemiological Practice on the website of the International Epidemiological Association (IEA)
• Good laboratory practice: Preventing introduction of bias at the bench
• SPIRIT: Standard Protocol Items - Recommendations for Interventional Trials
• SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trial
• SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
• SPIRIT 2025 Statement: updated guideline for protocols of randomized trials
• SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomized trials

• ICTRP: WHO International Clinical Trials Registry Platform
• DRKS: German Clinical Trials Registry
• PharmNet.Bund: Clinical Trials
• CTIS: Clinical Trials Information System
• EUCTR: EU Clinical Trials Register
• EudraCT: European Clinical Trials Database
• ClinicalTrials.gov: A service of the U.S. National Institutes of Health
• ISRCTN: International Standard Randomized Controlled Trial Number

• ICH-E 3: Note for Guidance on Structure and Content of Clinical Study Reports
• EMA: Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies
• ARRIVE guidelines: Animal research - Reporting in vivo experiment
• ARRIVE guidelines 2.0: Updated guidelines for reporting animal research
• ARRIVE guidelines 2.0: Reporting animal research - Explanation and elaboration
• CONSORT: Consolidated Standards of Reporting Trials
• CONSORT 2010 Statement: Extensions
• CONSORT 2025 Statement: updated guideline for reporting randomised trials
• CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials
• CARE: The CARE (CAse REport) guidelines
• EQUATOR: Library for health research reporting
• EQUATOR Network: Enhancing the QUAlity and Transparency Of health Research
• FAIR: Guiding Principles for scientific data management and stewardship
• GRADE: The Grading of Recommendations Assessment, Development and Evaluation Working Group
• ICMJE Recommendations: International Committee of Medical Journal Editors - Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals
• PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses
• PRISMA for Abstracts: Reporting Systematic Reviews in Journal and Conference Abstracts
• PRISMA-P (2015): Preferred reporting items for systematic review and meta-analysis protocols - elaboration and explanation
• PRISMA harms checklist: Improving harms reporting in systematic reviews
• QUADAS-2: A Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies
• REMARK: REporting recommendations for tumour MARKer prognostic studies
• SPIRIT-Outcomes 2022 Extension: Guidelines for Reporting Outcomes in Trial Protocols
• STARD: Standards for the Reporting of Diagnostic Accuracy Studies
• STROBE: Strengthening the Reporting of Observational Studies in Epidemiology
• STRICTA: Standards for Reporting Interventions in Clinical Trials of Acupuncture
• TREND: Transparent Reporting of Evaluations with Nonrandomized Designs
• TRIPOD: Transparent Reporting of a multivariable prediction model for individual prognosis or diagnosis - explanation and elaboration
• TRIPOD statement: Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis
• USB Köln: Scientific publishing

• EMA: European Medicines Agency
• EMA: European Medicines Agency - Paediatric medicine
• Bioethics Convention: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine ETS No.: 164 on the website of the Council of Europe
• EU CommissionDirective 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use and the requirements for authorization of the manufacturing or importation of such products
• EU Directive 2001/20/EC of the European Parliament and of the Council of April 4, 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
• EU Regulation 536/2014 of the European Parliament and of the Council of April 16, 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC (Clinical Trial Regulation, CTR)
• EU Regulation 2017/745: Medical Device Regulation (MDR)
• EU Regulation 2017/746 on in vitro diagnostic medical devices (In-Vitro Diagnostic Medical Devices Regulation, IVDR)
• EudraLex: The Rules Governing Medicinal Products in the European Union
• EU GDPR (EU Regulation 2016/679): General Data Protection Regulation of the European Union

• BfArM: Federal Institute for Drugs and Medical Devices
• BfS: Federal Office for Radiation Protection
• PEI: Paul Ehrlich Institute
• RKI: Robert Koch Institute
• DIMDI: German Institute for Medical Documentation and Information
• PharmNet.Bund: Portal for drug information of the federal and state governments
• KKS-N: Network of Coordination Centers for Clinical Trials

• AMG: Act on the Marketing of Medicinal Products on the website of the Federal Ministry of Justice
• MPG: Medical Devices Act on the website of the Federal Ministry of Justice
• MPDG: Act on the Implementation of Union Regulations on Medical Devices (Medical Devices Implementation Act) on the website of the Federal Ministry of Justice
• StrlSchG: Act on Protection against the Harmful Effects of Ionizing Radiation on the website of the Federal Ministry of Justice
• StrlSchV: Ordinance on protection against damage caused by ionizing radiation (Steel Protection Ordinance) on the website of the Federal Ministry of Justice
• TierSchG: Animal Protection Act on the website of the Federal Ministry of Justice
• BDSG: Federal Data Protection Act on the website of the Federal Ministry of Justice
• DSG NRW: Data Protection Act of North Rhine-Westphalia on the website of the Ministry of Justice of the State of North Rhine-Westphalia
• GDSG NW: Act on the Protection of Personal Data in the Healthcare Sector (Health Data Protection Act) on the website of the Ministry of Justice of the State of North Rhine-Westphalia
• HeilBerG: Heilberufsgesetz NRW on the website of the Ministry of the Interior of the State of North Rhine-Westphalia
• Professional code of conduct for North Rhine physicians on the website of the North Rhine Medical Association

• DFG: German Research Foundation - Clinical Trials
• DFG: Guidelines for safeguarding good scientific practice
• AKEK: Working Group of Medical Ethics Committees in the Federal Republic of Germany e.V.
• Ethics committees for clinical trials/performance evaluation trials on the website of the Federal Institute for Drugs and Medical Devices (BfArM)
• AWMF: Association of the Scientific Medical Societies in Germany
• The Cochrane Collaboration or German Cochrane Center
• Deutsches Ärzteblatt: Series of articles on the evaluation of scientific publications
• APE: Assistant for creating patient information and consent forms on the website of the Technology and Methods Platform for Networked Medical Research (TMF)
• Web calculator: Calculation of power and sample size for study planning