Clinical Trials during COVID-19
Repository of publications for Clinical Trials in relation to COVID-19.
Disclaimer
EFGCP does not own any of the data provided and cannot ensure the validity of each URL within the list below. Documents and Pages available through the links in this repository are the property of their respective owners, and are stored on the original publishing website. EFGCP is only providing an access to the orgiginal content, and cannot be held responsible for mis-information or mis-use of the provided information. All links have been initially tested, but EFGCP cannot be held responsible in case any technical issues occurs when accessing them or for the unavailability of the source material.
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| Document | Publisher | Date | Language | Country | Links |
| Guidance on the Conduct of Clinical Trials in Relation to the COVID-19 Situation | HSA | 2022-08-26 | English | Singapore | View |
| COVID-19 treatments: authorised | EMA | 2022-08-12 | English | EU | View |
| EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines | EMA | 2022-08-03 | English | EU | View |
| COVID-19 vaccines safety update | EMA | 2022-05-12 | English | EU | View |
| EMA’s governance during COVID-19 pandemic | EMA | 2022-05-06 | English | EU | View |
| Emergency Use Authorization for Vaccines to Prevent COVID-19 | FDA | 2022-03-31 | English | USA | View |
| Transparency: exceptional measures for COVID-19 medicines | EMA | 2022-03-11 | English | EU | View |
| Clinical trials applications for Coronavirus (COVID-19) | MHRA | 2022-02-23 | English | United Kingdom | View |
| Coronavirus (COVID-19) vaccines adverse reactions | MHRA | 2022-02-17 | English | United Kingdom | View |
| How tests and testing kits for coronavirus (COVID-19) work | MHRA | 2022-02-14 | English | United Kingdom | View |
| EMA HMA EC Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic | EMA, HMA, EC | 2022-02-10 | English | EU | View |
| GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC | European Commission | 2022-02-10 | English | EU | View |
| COVID-19 Public Health Emergency Policy on COVID-19-Related Sanitation Tunnels | FDA | 2022-02-08 | English | USA | View |
| Conducting a COVID-19 drug and vaccine clinical trial | Health Canada | 2022-02-08 | English | Canada | View |
| Guidance document Authorisation procedures for Covid-19 medicinal products during a pandemic HMV4 Version 5.0 | Swissmedic | 2022-02-01 | English,French, German | Switzerland | View |
| Medical Devices for Covid 19: Conducting a Clinical Trial | Health Canada | 2022-01-26 | English | Canada | View |
| REGULATION (EU) 2022/123 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices | European Commission | 2022-01-25 | Multiple | EU | View |
| Accelerating Clinical Trials in the EU (ACT EU) Delivering an EU clinical trials transformation initiative | HMA/EMA | 2022-01-13 | Multiple | EU | View |
| Investigational COVID-19 Convalescent Plasma | FDA | 2022-01-07 | English | USA | View |
| Managing clinical trials during coronavirus (COVID-19) | MHRA | 2021-11-17 | English | United Kingdom | View |
| EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines | EMA | 2021-09-16 | English | European Union | View |
| FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic - Update 04-Dec-2020 | FDA | 2021-08-30 | English | USA | View |
| Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors | Health Canada | 2021-05-06 | English | Canada | View |
| Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 | Health Canada | 2021-05-03 | English | Canada | View |
| Ireland (HPRA) advice for Clinical trials In relation to COVID 19 | HPRA | 2021-04-07 | English | Ireland | View |
| Norway (NoMA) guidance for clinical trials during the COVID-19 pandemic (Updated 25/03/2021) | NoMA | 2021-03-25 | Norwegian | Norway | View |
| Clinical Trial Sponsor Guidelines for Emergency Management | ALIMS | 2021-03-24 | Serbian (Cyrillic) | Serbia | View |
| Clinical Trials During the COVID-19 Pandemic - Supplementary recommendations of BfArM and PEI to European Guidance, version 4 | BfArM | 2021-02-25 | German | Germany | View |
| Clinical Trials During the COVID-19 Pandemic | BfArM | 2021-02-25 | German | Germany | View |
| Special additional recommendations for Greece regarding European Instructions for management of Clinical Trials during COVID-19 pandemic | EOF | 2021-02-17 | Greek | Greece | View |
| Clinical Trials during the COVID-19 Pandemic | MPA | 2021-02-15 | English | Sweden | View |
| France (ANSM) Ongoing clinical trials in relation to COVID 19 | ANSM | 2021-02-12 | English | France | View |
| France (ANSM) Ongoing clinical trials in relation to COVID 19 | ANSM | 2021-02-12 | French | France | View |
| ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness | ICMRA | 2021-01-19 | English | Global | View |
| Good clinical practice of medicinal products during the COVID-19 pandemic | GCPpl, INFARMA, PolCRO | 2021-01-11 | English | Poland | View |
| Good clinical practice of medicinal products during the COVID-19 pandemic | GCPpl, INFARMA, PolCRO | 2021-01-11 | Polish | Poland | View |
| Joint Guidance of Swissmedic and swissethics on the Management of Clinical Trials with Medicinal Drug Products in Switzerland During the COVID-19 Pandemic v2.4 | Swissmedic | 2020-12-17 | English | Switzerland | View |
| Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines | EMA | 2020-11-13 | English | European Union | View |
| Guidance on minimising disruptions to the conduct and integrity of clinical trials of medicines during COVID-19 | MHRA | 2020-11-11 | English | United Kingdom | View |
| NIHR - Guidance for a 'second wave’ of COVID-19 activity | UK NIHR | 2020-10-12 | English | United Kingdom | View |
| Denmark (DKMA) advice for Clinical trials In relation to COVID 19 | DKMA | 2020-10-07 | English | Denmark | View |
| Repository of Information from the CCMO for Clinical Trials during the COVID19 Pandemic | CCMO | 2020-09-30 | Dutch | The Netherlands | View |
| Repository of Information from the CCMO for Clinical Trials during the COVID19 Pandemic | CCMO | 2020-09-30 | English | The Netherlands | View |
| Estonia (Ravimiamet) advice for Clinical trials In relation to COVID 19 (Updated 29/09/2020) | Ravimiamet | 2020-09-29 | English | Estonia | View |
| Clinical trials with trial participants can be gradually (re)started in The Netherlands | Dutch Ministry of Health | 2020-08-26 | English | The Netherlands | View |
| Conditions to (re)start Clinical Trials in The Netherlands | Dutch Ministry of Health | 2020-08-25 | Dutch | The Netherlands | View |
| COVID19: Impact on Clinical Trials Conducting under the law of Scientific Research Involving Humans | Dutch Ministry of Health | 2020-08-25 | Dutch | The Netherlands | View |
| Guidelines to Sponsors, Sites, and Researchers re Clinical Research and Bioequivalence Studies | ANVISA | 2020-07-28 | Portuguese | Brazil | View |
| Exceptional measures applicable to clinical trials to manage problems arising from the COVID-19 emergency | AEMPS | 2020-07-01 | Spanish | Spain | View |
| Guidelines for Clinical Trials during COVID-19 Emergency | INS | 2020-06-26 | Spanish | Peru | View |
| Clinical trials with trial participants can be gradually (re)started in The Netherlands | Dutch Ministry of Health | 2020-06-25 | Dutch | The Netherlands | View |
| Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency | FDA | 2020-06-17 | English | USA | View |
| Conditions for (re)starting studies in Clinical Research Units | CCMO | 2020-06-09 | English | The Netherlands | View |
| Netherlands (CCMO) advice for Clinical trials In relation to COVID 19 | CCMO | 2020-05-26 | English | The Netherlands | View |
| Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 Pandemic | EMA, HMA, EC | 2020-05-26 | English | European Union | View |
| Simplified procedures for studies and compassionate therapeutic use programs for the emergency from COVID-19 | AIFA | 2020-05-22 | Italian | Italy | View |
| Framework for Restarting NIHR Research Activities which have been Paused due to COVID-19 | UK NIHR | 2020-05-21 | English | United Kingdom | View |
| Clinical Trials During the COVID-19 Pandemic - Supplementary recommendations of BfArM and PEI to European Guidance, version 3 | BfArM | 2020-05-19 | English | Germany | View |
| Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic | arXiv (Cornell University) | 2020-05-14 | English | View | |
| Exceptional measures in the context of Clinical Trials during the period of risk to public health (COVID-19) | INFARMED | 2020-05-11 | Portuguese | Portugal | View |
| Guidelines for Clinical Trials in Slovakia During the COVID-19 Exceptional Situation | ŠÚKL | 2020-05-06 | Slovakian | Slovakia | View |
| National Guidelines for Ethics Committees Reviewing Biomedical & Health Research During COVID-19 Pandemic | ICMR | 2020-05-06 | English | India | View |
| OGYÉI (Hungary) - Information on the Continuity of Clinical Trials Under COVID-19 (coronavirus) | OGYÉI (Hungary) | 2020-05-05 | Hungarian | Hungary | View |
| Guidance on the Management of Clinical Investigations during the COVID-19 (Coronavirus) Pandemic | FAMHP | 2020-04-30 | English | Belgium | View |
| Belgium (FAMHP) Guidance for Clinical trials In relation to COVID 19 | FAMHP | 2020-04-29 | English | Belgium | View |
| Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic - v3.0 28-Apr-2020 | European Commission | 2020-04-28 | English | European Union | View |
| CDISC Guidance for Ongoing Studies Disrupted by COVID-19 Pandemic | CDISC | 2020-04-21 | English | Global | View |
| Guidance to Sponsors and Investigators for Conduct of Clinical Trials during the COVID-19 Pandemic in Kenya | PPB | 2020-04-20 | English | Kenya | View |
| Open-access Global COVID-19 Clinical Trial Tracker | Cytel | 2020-04-11 | English | Global | View |
| COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors | TGA, NHMRC, and CTPRG | 2020-04-09 | English | Australia | View |
| Guidance for Research Impacted by COVID-19 | HHS OHRP | 2020-04-08 | English | U.S.A. | View |
| Spain (AEMPS) advices for Clinical trials In relation to COVID 19 | AEMPS | 2020-04-07 | Spanish | Spain | View |
| Management of clinical studies in Italy during the COVID-19 emergency | AIFA | 2020-04-07 | Italian | Italy | View |
| Statement of Polish Society of Ethics Committee Members and Employees on ethics committees activities for clinical trials in relation to COVID-19 | SCiPKBwP | 2020-04-06 | Polish | Poland | View |
| EMA recommendations on compassionate use of remdesivir for COVID-19 | EMA | 2020-04-03 | English | European Union | View |
| Notification on MedDRA terms for coronavirus | MedDRA | 2020-04-01 | English | Global | View |
| EU Link to National Guidance on CT Management During the COVID-19 Pandemic | EU HMA CTFG | 2020-03-31 | English | European Union | View |
| Communique regarding prioritization of clinical trials for COVID-19 | OGITT/INS | 2020-03-30 | Spanish | Peru | View |
| European (EMA) advices for Clinical trials In relation to COVID 19 | EMA | 2020-03-27 | English | Europe | View |
| Romania (AMNDMR) advices for Clinical trials In relation to COVID 19 | AMNDMR | 2020-03-27 | Romanian | Romania | View |
| Netherlands (CCMO) Accelerated Procedure fast track Assessment of Coronavirus Research Files | CCMO | 2020-03-27 | English | The Netherlands | View |
| Italy (AIFA) Repository of guidances for Clinical Trials in relation to COVID 19 | AIFA | 2020-03-27 | Italian | Italy | View |
| Denmark (DKMA) puts Site Inspection and Control Tasks on hold - COVID 19 | DKMA | 2020-03-26 | English | Denmark | View |
| Communique regarding sponsor considerations for ongoing clinical trials during COVID-19 outbreak | OGITT/INS | 2020-03-26 | Spanish | Peru | View |
| Policy on Conduct of Clinical Trials of Health Products During the Current COVID-19 Pandemic | SAHPRA | 2020-03-25 | English | South Africa | View |
| COVID-19 Clinical Trials Information | NAMMDR | 2020-03-25 | English | Romania | View |
| Hungary (OGYÉI) advice for Clinical trials In relation to COVID 19 | OGYÉI | 2020-03-24 | Hungarian | Hungary | View |
| United Kingdom (MHRA) Guidance on Coronavirus - Update 24/03/2020 | MHRA | 2020-03-24 | English | United Kingdom | View |
| Recommendations to the Sponsors for managing of Clinical Trials during the COVID-19 pandemic and the declared State of emergency in the Republic of Bulgaria | BDA | 2020-03-24 | English | Bulgaria | View |
| FDA guidance on Clinical Trials in relation to Coronavirus | FDA | 2020-03-20 | English | USA | View |
| FDA Inspections outside the US | FDA | 2020-03-20 | English | USA | View |
| U.K. NHS HRA COVID-19: Guidance for Sponsors, Sites and Researchers (v2.1 20 March 2020) | U.K. NHS Health Research Authority | 2020-03-20 | English | United Kingdom | View |
| Guidance to Sponsors on How to Manage Clinical Trials During the COVID-19 Pandemic | MoH | 2020-03-20 | English | Cyprus | View |
| Expedited Evaluation Strategy of Drug Research Protocols for COVID-19 | INVIMA | 2020-03-20 | Spanish | Colombia | View |
| Measures to be Taken in Clinical Research Due to COVID-19 Pandemic - FAQs | TITCK | 2020-03-20 | Turkish | Turkey | View |
| Finland (FIMEA) advice for Clinical trials In relation to COVID 19 | FIMEA | 2020-03-19 | English | Finland | View |
| Poland (URPL) advice for clinical trials in relation to COVID-19 | URPL | 2020-03-19 | Polish | Poland | View |
| Processing of Personal Data in the Context of the COVID-19 Outbreak | EDPB | 2020-03-19 | English | European Union | View |
| Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials | FDA | 2020-03-18 | English | USA | View |
| Communique regarding clinical trial initiation, maintenance, and conclusion during COVID-19 outbreak | OGITT/INS | 2020-03-18 | Spanish | Peru | View |
| Austria (BASG) advice for Clinical trials In relation to COVID 19 | BASG | 2020-03-17 | English | Austria | View |
| Latvia (SAMRL | ZVA) advice for Clinical trials In relation to COVID 19 | SAMRL (ZVA) | 2020-03-17 | English | Latvia | View |
| Coronavirus clinical research guidelines | INVIMA | 2020-03-17 | Spanish | Colombia | View |
| Latvia (SAMRL | ZVA) advice for Clinical trials In relation to COVID 19 | SAMRL (ZVA) | 2020-03-16 | Latvian | Latvia | View |
| Slovakia (ŠÚKL) advice for Clinical trials In relation to COVID 19 | ŠÚKL | 2020-03-16 | Slovakian | Slovakia | View |
| Slovenia (JAZMP) advice for Clinical trials In relation to COVID 19 | JAZMP | 2020-03-13 | Slovenian | Slovenia | View |
| ACRO Considerations to Support Clinical Trial Monitoring Oversight During COVID 19 | ACRO | 2020-03-13 | English | USA | View |
| Italy (AIFA) advice for Clinical trials In relation to COVID 19 | AIFA | 2020-03-12 | English | Italy | View |
| United Kingdom (MHRA) Advice for Management of Clinical trials in relation to COVID 19 | MHRA | 2020-03-12 | English | United Kingdom | View |
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| For industry and manufacturers: COVID-19 tests and testing kits | MHRA | 0000-00-00 | English | United Kingdom | View |
| Emergency Use Authorization for Vaccines to Prevent COVID-19 | FDA | 0000-00-00 | English | USA | View |
| COVID-19 vaccines safety update | EMA | 0000-00-00 | English | EU | View |