FDA has released the Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 pandemic

March 19, 2020

Yesterday morning FDA has released the Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 pandemic.

Here are the parts of Guideline recommendations that may be successfully followed with Flex Databases system:

Protocol deviations and IRBs/IEC submissions tracking

The Guideline states, that “FDA recognizes that protocol modifications may be required and that there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 control measures.”  In CRA Activity Management module, Flex Databases has inbuilt protocol deviations tracking – so a user can easily track all occurring deviation and make further reporting much more comfortable.

It also mentions that “Sponsors and clinical investigators are encouraged to engage with IRBs/IEC as early as possible when urgent or emergent changes to the protocol or informed consent are anticipated as a result of COVID-19.” Investigators & Sites Management module provides centralized ethic committees submissions and approval tracking to speed-up communications between both sides of the process.

Study data integrity

Several times FDA mentions the importance of trial integrity. The Guideline states, that “Efforts to minimize impacts on trial integrity, and to document the reasons for protocol deviations, will be important.” Flex Databases system is equipped with a full audit trail to ensure that no data is ever lost. Any activity inside of the system is reported precisely on Who does What, When, and Why.

Changes in policies and procedures

The Guideline says, that “Sponsors, clinical investigators, and IRBs should consider establishing and implementing policy and procedures, or revise existing policy and procedures, to describe approaches to be used to protect trial participants and manage study conduct during possible disruption of the study as a result of COVID-19 control measures at study sites.“

With Flex Databases system, our clients can optimize and automate the following:

• study visits and procedures
• study monitoring
• adverse event reporting
• changes in investigator(s), site staff, and/or monitor(s) secondary
• and many more aspects of clinical trial management.

Flex Databases system ensures full business continuity, regulatory compliance, and data integrity, which importance is clearly stated in the Guideline. We are ready to provide any additional support and answer any questions to make a difficult period we are passing through to go as smoothly as it is ever possible. The level of service and system uptime will not be affected during the time of the crisis.

We carefully follow all changes in relevant regulations both on global and local levels and design system updates in compliance with the actual situation in the industry.

If you have any questions regarding Flex Databases compliance with the new FDA Guideline or any other needs, do not hesitate to contact us via contact@flexdatabases.com.

Stay at home,

Flex Databases