Table 1 AKTN COVID-19 trial response checklist template

 Initial communication with individual investigators to understand and address local conditions and restrictions

 Strategy for Site Investigators to consult with the Chief Investigator on individual study participant’s safety, welfare and rights are best served by:

  a) Continuing in the study under the existing protocol,

  b) Under a modified version, or by

  c) Discontinuing participation based on the specific circumstances

 Communication plan for regular updates to trial sites

 Resources for site staff to communicate information to participants regarding the research team’s response to COVID-19, and changes to study and monitoring plans that could impact them

 Human Research Ethics Committee notified of participant communication plan

 Communication plan in place for disseminating information to local and global Trial Steering Committee

 Funder communication

 Data and Safety Monitoring Board communication

 Additional safety monitoring for trial participants who no longer have access to investigational product or the investigational site

 When sites are experiencing pandemic-related employee absenteeism, will reports be stored or submitted later?

 Strategy to record adverse events that have been stored for later reporting

 Can the trial continue under the existing protocol considering current conditions?^a

 Is an amendment required to the informed consent form?

 Plans in place to delay some assessments for the trial, or stop ongoing recruitment, or withdraw trial participants

 The research team has conducted an evaluation of alternative methods for trial assessments/conduct (phone contacts, virtual visits, home delivery of the investigational product)

 Resources sent to sites to document all COVID-related changes and protocol deviations on a participant-by-participant basis, including the reason for the change or deviation

 Investigational product: determination has been made to either continue the study as per protocol or discontinue the use of an investigational product based on:

  a) ability to conduct appropriate safety monitoring and/or

  b) impact on the investigational product supply chain

 Adjust trial monitoring plan to account for COVID-19-related modifications and deviations

 Adjust trial monitoring plan to incorporate increased central and remote monitoring surveillance to maintain site oversight

 The research team has considered how the statistical analysis plan and protocol deviations related to COVID-19 will be handled for pre-specified analyses before locking clinical trial database

 A document mapping possible missing data and the information required from sites to explain missing data due to COVID-19 disruptions in the main results publications has been developed^b

 Document the impact of the pandemic on informed consent processes, study visits and procedures, study monitoring and data collection, adverse event reporting, and changes in investigators, site staff and monitors. All policies and procedures will need to continue to be compliant with regional or national policies regarding COVID-19^c

 Establish and implement trial-specific procedures or revise existing ones to describe how study participants will be protected and how the trial will be managed during possible COVID-19 disruptions