Guidelines for amending clinical trial documents due to COVID. Russian Experience.

You need to respond quickly to an ever-changing operating environment in a COVID-19 pandemic.  Today, we will tell you how to proceed in such an environment.

First and foremost, it is worth paying attention to risk assessment and ensuring the safety of study subjects. If there are deviations from the protocol, changes in the administrative and logistical aspects of the study, special attention should be paid to documenting each fact and the reason for such a deviation.

We have conducted a thorough analysis and compiled a list of documents that are very likely to change.

First of all, at the company level, we should pay attention to SOPs (standard operating procedures) – documented instructions on how to perform work procedures, designed to achieve uniformity in the performance of certain activities. It is recommended that SOPs and their accompanying forms provide for home visits to patients and remote monitoring.  After the SOPs are amended, staff training programs are changed.

After that, we move to the project level and make changes to the plans.

The project management plan describes the responsibilities of the project manager during the study, identifies specific team members and their roles, and describes specific processes and procedures, as well as describing the interaction and documentation of the project. This document should revise the approach to project management, working with vendors, and project timelines.

The monitoring plan defines the order of action of the project team in the organization of the clinical trial, describes the processes and procedures for monitoring the clinical center. In this document, it is necessary to prescribe options for remote monitoring, central monitoring, subsequent data verification (post-SDV).

Then the main documents of the study are modified: the protocol, the informed consent, and the instructions for the physicians of the patients and the medical staff of the centers. At the same time, care must be taken to ensure that the new versions of the documents are approved by the appropriate authorities (Ministry of Health of the Russian Federation, EC).

Clinical trial coordinators may decide the issue differently if in the specific circumstances their adoption would be in the interests of the patients of the clinical trials.