New feature streamlines user training with documented self-certification

To ensure high data quality and patient safety, users are required to be knowledgeable in the systems they work with, and familiar with study-specific information such as what data to collect, and how to handle the medicinal product under investigation. Viedoc’s new self-certification feature gives sponsors full control over which training users need to complete to gain access to the study. And it’s all documented.

According to Good Clinical Practice, the sponsor is responsible for all users being appropriately trained in the required protocols and systems in any given study. The ICH Good Clinical Practice guidelines state that investigators should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial. The investigator should also be thoroughly familiar with the appropriate use of the investigational product: how should the product be handled, stored, dispensed, and administered, and any unused product returned at the end of the study. It is the sponsor’s task to ensure that written instructions are in place describing these procedures, and that the investigators have received and understood this information. 

Quality and timeliness of data collection also depends on the users being familiar with the system they work with. Clear instructions on how to add subjects, enter data in the CRFs, raise, answer and approve queries, and export data need to be available for users at any time. All this is necessary for maintaining quality and ensuring compliance with the protocol and the applicable standards and regulatory requirements. 

To support this, Viedoc has now launched a self-certification feature enablingsponsors to choose what type of training a user needs to complete before gaining access to the CRFs. The module can be designed from Viedoc’s own eLearning material, film clips, the study protocol and study documents or possibly links to a web page with information to be read – or any combination of these. The documentation and training materials can be set to mandatory reading before the user can launch the study, or set to optional reading that is available for reference at any time during study progress. 

“This is a feature that greatly facilitates site training and streamlines the research process as a whole,” says Henrik Blombergsson, co-founder and COO of Viedoc. 

When a user has completed the mandatory sections set out by the sponsor, they immediately receive an automatically generated certificate and gain access to the study.

The GCP guidelines also require sponsors to ensure that the information provided is up to date. Investigator Brochures are reviewed at least annually and revised as new information regarding the investigational product, or anything else in the trial, becomes available. Sometimes, relevant information may be so important that it should be communicated to the investigators even before a revision of the Investigational Brochure has been realized. Supplying the sites with such information in a timely manner greatly assists in the successful management of the trial, and at Viedoc we have even thought about that! 

“The sponsor has the option to make each user repeat the certification at an interval the sponsor chooses. This ensures that each user is regularly updated and aware of potential updates or changes within the study,” says Henrik, and continues: 

“To have users with adequate knowledge about the system and the specific study parameters is crucial to guarantee quality of the study and safety for the participating patients. Viedoc’s documented self-certification helps ensure this.”