Annotated report is an arrangement of all the things to look after in a monitoring visit.
On an annotated report, study teams want you to talk about subject recruitment on monitoring visit and many other study related things that are discussed below:
Subject recruitment is important for the site selection for studies. Sponsors and CRAs also stay concerned about the subject recruitment in the site. The SIV report, PI questionnaire, feasibility survey and the number of patients enrolled by the site are also mentioned in an annotated report.
Annotated report also include question especially for the patient enrollment that also leads to action items.
Informed consent includes all the study related information. Study coordinators and PIs use this informed consent to educate the patients regarding to the study and the trials, in order to satisfy and convince them to participate in the studies.
Queries and action items:
In this section of annotated report, general questions are asked about studies and data as current availability of data at site. This section includes a lot of queries about all the missing points and query resolution. All these are yes or no questions that are checked with CTMS system that can be about protocol deviations to report, site qualification and any kind of serious adverse event being reported by the site. There can be a query about Investigational product such as following up the randomization process according to the protocols, unexpired IP, facility equipment and there can be many follow-up questions. Questions about the availability of all the essential documents in the TMF are most important.
- Every CRO have study team leads, project manager, lead CRAs, clinical trial leads and sponsors to come up with the annotated report for particular studies.