EFGCP-AWP Covid-19 Repository

Repository of publications for Clinical Trials in relation to COVID-19

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EFGCP does not own any of the data provided and cannot ensure the validity of each the URL within the list below. Documents and Pages available through the links in this repository are the property of their respective owners, EFGCP 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.
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Document Publisher Date Language Country Links
EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines EMA 2021-09-16 English European Union View
Managing clinical trials during coronavirus (COVID-19) MHRA 2021-09-08 English United Kingdom 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
EMA HMA EC Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic EMA, HMA, EC 2021-02-04 English Europe 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
Guidance on the Conduct of Clinical Trials in Relation to the COVID-19 Situation HSA 2020-07-29 English Singapore 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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