Annotated reports are very important in monitoring and clinical aspects of clinical research. Annotated report is a document that includes all the protocols of conducting monitoring visits and monitoring calls. This includes all the bullet points that a monitor can hit during visits. Annotated notes includes the list of things that a monitor should hit such as subject recruitment, randomization process, informed consent and training of the site staff. Monitors are given these annotated report documents in order to make sure that they conduct all the protocols during the monitoring visits. Sponsors and study teams wants all the protocols to be conducted that are mentioned within annotated report.
These annotated reports are important to be conducted throughout the studies and monitoring visit, to make sure that the data is accurate because these monitoring visits occur after weeks and everything should be covered within the visit. This also helps to cover the FDA audit in approval of the studies.
The lead CRA is the one who comes up with an annotated report and do it in conjunction with the project manager and with the sponsor team because they are the ones paying for the trial and are going to be overseeing the monitoring aspect that is the most important aspects of the trial. They want to make sure that at every visit everything should be covered.