Corrections to clinical trial documents due to COVID-19. Russian experience.
It’s important to respond quickly to an ever-changing environment in a COVID-19 pandemic. Today we will tell you how to function with clinical trials in accordance to new conditions.
The most important thing is to pay additional attention to risk assessment and ensure the safety of study subjects. Every protocol deviation or other serious change of the study should be analyzed and documented.
We have conducted a thorough analysis and compiled a list of documents that are very likely to change soon.
First of all, on company level we should pay attention to SOP’s (standard operating procedures) – documented instructions of how to perform work procedures, designed to achieve uniformity of certain activities. It is recommended to provide remote monitoring and home visits to patients. It also includes changes in staff training programs after SOP’s amendments.
Secondly, we go to the project level. The project management plan describes the responsibilities of the project manager during the study, identifies roles of specific team members and describes processes and procedures. This document should revise vendor management, project timelines and the approach to project management generally.
Another important part of clinical trial is monitoring plan. It defines actions of the project team and describes procedures of clinical center monitoring. In this document it’s necessary to prescribe options for remote monitoring, central monitoring and subsequent data verification (post-SDV).
Then the main documents of the study should be modified: the protocol, the informed consent, the instructions for the physicians of the patients and the medical staff of the centers. At the same time, it is necessary to ensure that new versions of documents are approved by the relevant authorities (Ministry of Health of the Russian Federation).
We should also mention that decisions of clinical trial coordinators can be different depending on the interests of the clinical trial patients in their particular circumstances.
