The documentation of each project starts with the appropriate agreements to define tasks and responsibilities, the design, the data type and how to collect them, the statistical methods to use and the relevant project management. The next steps cover the tasks for the clinical study/investigations in the clinical site, the data management, the statistic evaluation and the writing of a final report.
Audits/inspections will then verify if the documentation is available and if the requirements are fulfilled as per the applicable regulations.
As Quality Manager I see myself responsible not only for transmitting information and regulatory requirements, but also for raising awareness between employees. In this sense, it is particularly important to transfer the reasons behind the intensive documenting process.
Therefore, a person able to understand this effort and to internalise the fact that subjects´ safety and data integrity are at the forefront, won´t question the effort itself and will be ready to implement the documenting process in an adequate manner.
It´s for this purpose that each year at ICRC-Weyer we attend a GCP Training, which mainly focuses on ethical aspects as those covered by the Declaration of Helsinki, the GCP principles of ICH E6 and DIN EN ISO 14155 as well as further clinical research requirements and responsibilities like the ALCOA+ principle.
Maria Schulz, Quality Manager and Author
Viviana Lerario, Technical Editor