COVID-19
In the wake of COVID-19 outbreak globally, government agencies in India and others (globally) have set out guidance for researchers. Following is a list of important links which may help researchers access relevant information and publications:
Please note the WHO has requested that the WHO official acronym for the Coronavirus disease (COVID-19) is to be entered in the title field of the trial registration dataset. This will facilitate finding and extracting all clinical trials related to COVID-19, from the public databases.
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Guidance for research applications to support COVID-19 R&D in India |
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S. No. |
Agency |
Link |
| 1. | Central Drugs Standard Control Organization (CDSCO) | Notice regarding the regulatory pathway for R&D for in-vitro diagnostic kits for the diagnosis of COVID-19. |
| 2. | Central Drugs Standard Control Organization (CDSCO) | Notice regarding the regulatory pathway for R&D of drug or vaccine for prevention or treatment of COVID-19. |
| 3. | Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India | Rapid response regulatory framework for COVID-19, to deal with applications for development of vaccines, diagnostics, prophylactics and therapeutics
The document details on the timeline laid down by DBT in consultation with the Drug Controller General of India (DCGI), to fast track the regulatory approval process of applications for development of vaccines, diagnostics, prophylactics and therapeutics for COVID-19. |
Important links from global agencies:
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Guidance for managing existing clinical trials during COVID-19 |
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| S. No. | Agency |
Link |
| 1. | Medicines and Healthcare products Regulatory Agency (MHRA) (UK Government) | Managing clinical trials during Coronavirus (COVID-19) |
| 2. | MHRA | Guidance for Good Laboratory Practice (GLP) facilities in relation to Coronavirus (COVID-19) |
| 3. | MHRA | Medical devices clinical investigations during the Coronavirus (COVID-19) outbreak
(advice for investigators and sponsors of ongoing clinical investigations and new applications) |
| 4. | European Medicines Agency (EMA) | Guidance on the management of clinical trials during the COVID-19 (Coronavirus) pandemic |
| 5. | U.S. Food and Drug Administration (FDA) | Guidance on conduct of clinical trials of medical products during COVID-19 pandemic
This document contains guidance for the industry, investigators, and Institutional Review Boards (Institutional Ethics Committees). |
| 6. | World Health Organization (WHO) | Coronavirus disease (COVID-19) technical guidance: Maintaining essential health services and systems |
| 7. | NHS Health Research Authority | COVID-19: Guidance for sponsors, sites and researchers (v2.2, 26 March 2020)
This link contains guidance for both, new studies relating to COVID-19 and amendments to existing studies to address COVID-19 elements. |
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Guidance for research applications to support COVID-19 R&D |
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S. No. |
Agency |
Link |
| 1. | World Health Organization (WHO) | Ethical standards for research during public health emergencies: Distilling existing guidance to support COVID-19 R&D |
| 2. | MHRA | How to place a Coronavirus (COVID-19) test kit on the market
(what manufacturers need to know) |
| 3. | MHRA | Clinical trial applications for Coronavirus (COVID-19) |
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Calls for proposals by Indian agencies |
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S. No. |
Agency |
Link |
| 1. | Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC) | DBT and BIRAC have announced a COVID-19 Research Consortium, and seek Request for Proposals, with a focus on diagnostics, vaccines, novel therapeutics, repurposing of drugs or any other intervention for control of COVID-19. |
| 2. | Technology Development Board (TDB), Department of Science and Technology (DST) | TDB invites technology proposals for fighting COVID 19 |
| 3. | Technology Development Board (TDB), Department of Science and Technology (DST) | Innovative Israeli companies with solutions for COVID-19 |
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Calls for proposals |
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| S. No. | Agency |
Link |
| 1. | World Health Organization (WHO) | WHO R&D Blueprint novel Coronavirus – Outline of designs for experimental vaccines and therapeutics |
| 2. | World Health Organization (WHO) | Invitation to manufacturers of in vitro diagnostics for SARS-CoV-2 to submit an application for emergency use listing by WHO (date issued: 28 February 2020). |
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