The picturesque path of scientific progress is marked by numerous challenges and obstacles. For instance, medical research and clinical trials, in particular, face a wide variety of practical issues. Recruitment, funding, and deadlines are only some of them. Often professionals and sponsors focus on participants, procedures, and outcomes. As a result, researchers may forget about one of the most crucial aspects: Good documentation. However, professionals worldwide agree on the importance of good source documentation. Because, as the saying goes, “If it wasn’t documented, it wasn’t done.”
Good source documentation is one of the most significant aspects of research. Worksheets, scans, emails, and so much more that may help researchers document and communicate their findings.
Paper-originated Source Documentation:
Usually, paper-originated source documentation is the easiest way to document changes and results. On top of that, when it comes to paper forms, training is not needed. All you need is a pen and a piece of paper to write down your thoughts, right? However, paper-originated source documents make it difficult to access data or perform remote monitoring. In addition, this method is prone to many issues related to readability and confidentiality of data. Therefore, pen and paper techniques have been slowly replaced by electronic formats.
Electronic Health Records:
Medicine and science face numerous technical advancements, so it’s natural to accept the usage of electronic health records in clinical trials.
However, we can witness a research paradox: as access to electronic documentation is not always guaranteed in multi-center trials, experts are forced to print electronic forms. In other words, electronic records are being transformed into paper source forms.To resolve all research issues related to accessibility, credibility, and safety of information, experts talk more and more about certified copies. Both the Food and Drug Administration (FDA) and the International Conference on Harmonization (ICH) for Good Clinical Practice (GCP), E6 R2, emphasize the importance of certified copies along with original source documents.
Certified copies are defined as: “A copy (paper or electronic) of original information that has been verified, as indicated by a dated signature, as an exact copy, having all of the same attributes and information as the original.” and “A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original.” (by the FDA and the E6 R2, respectively). In other words, when a copy is validated/certified, it counts as an original document, and it can replace paper forms.
What Does That Mean?
This is a promising step for clinical trials. Certified copies may facilitate research, multi-center analysis, and audits. Note that if monitors can access data remotely, they can exercise the same levels of control as if they were on-site.
Qolty is an advanced CTMS, which gives practitioners, investigator sites, and audit trials a unique chance to access valid and credible data at all times. Qolty gives users the opportunity to obtain automatically generated certified copies. Qolty also includes full audit settings. To sum up, CTMS like Qolty, which acknowledge the importance of certified copies, help experts and investigators contribute to the research process and benefit clients.