Table 1.

AKTN COVID-19 trial response checklist template

Item/task/stakeholders	Complete
Communication
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
Safety
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
Trial conduct
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
Monitoring
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
Data management and analysis
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
Risk management
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

^aIf emergent or urgent changes are likely to be made to the protocol or informed consent, communicate these to the Human Research Ethics Committee in advance where possible

^bThe expectation is the AKTN will include the relationship of the missing information to COVID-19 and this should be summarised in the final clinical study report

^cAKTN will need to describe the implemented contingency measures related to COVID-19, including a list of impacted participants by participant number and site (including how the individual’s participation was affected), and provide an analysis and discussion regarding the impact of the contingency actions on safety and efficacy results