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. 2021 Jun 29:M21-1269. doi: 10.7326/M21-1269

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This article is made available via the PMC Open Access Subset for unrestricted re-use for research, analyses, and text and data mining through PubMed Central. Acknowledgement of the original source shall include a notice similar to the following: "© 2020 American College of Physicians. Some rights reserved. This work permits non-commercial use, distribution, and reproduction in any medium, provided the original author and source are credited." These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections.

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Appendix Figure 2. Timelines for ACTIV master protocol development. Each ACTIV master protocol undergoes 3 main development stages: 1) protocol development and approval, which consists of designing and drafting the protocol, onboarding participating companies for the refinement of the protocol, submitting for Food and Drug Administration (FDA) pre–investigational new drug (IND) review, revising the protocol, and submitting for FDA IND review; 2) operational planning/setup, which consists of assembling required resources (e.g., sponsors, networks, and contract research organizations) and initiating the study at the site level (e.g., site registration and activation); and 3) ongoing operations, which consists of trial execution, protocol amendments, and additional site identification, registration, and activation. ACTIV = Accelerating COVID-19 Therapeutic Interventions and Vaccines. — Each ACTIV master protocol undergoes 3 main development stages: 1) protocol development and approval, which consists of designing and drafting the protocol, onboarding participating companies for the refinement of the protocol, submitting for Food and Drug Administration (FDA) pre–investigational new drug (IND) review, revising the protocol, and submitting for FDA IND review; 2) operational planning/setup, which consists of assembling required resources (e.g., sponsors, networks, and contract research organizations) and initiating the study at the site level (e.g., site registration and activation); and 3) ongoing operations, which consists of trial execution, protocol amendments, and additional site identification, registration, and activation. ACTIV = Accelerating COVID-19 Therapeutic Interventions and Vaccines.