I am at loggerheads with a sponsor of a clinical trial that is declaring that they have no responsibility for identifying queries that need to be resolved at clinical trial sites within a multi site trials.
I would argue there is a scientific and ethical imperative for clinical trial sponsors to generate queries.
Can anybody provide substantiation for my opinion?
Vaughn McCall
You're absolutely correct in your stance. The sponsor of a clinical trial has a significant role and responsibility in ensuring the integrity, safety, and ethical conduct of the trial. This includes generating and resolving queries related to the data collected at clinical trial sites. Here are some points that substantiate your opinion:
William Vaughn McCall To guarantee that the trials adhere to the protocol and relevant regulations, and to maintain the accuracy/integrity of collected data, it is important for sponsors to actively monitor and raise any concerns, even if the responsibility for these tasks primarily lies with the Contract Research Organization (CRO). I am surprise that the sponsor in this case take no responsibility in this.
In clinical trials, generating queries and resolving data discrepancies is typically the responsibility of the data management team. The data management team is a critical part of the clinical trial process and is often composed of individuals with expertise in clinical data management, database programming, and regulatory requirements.
During a clinical trial, data is collected from various sources, such as electronic case report forms (eCRFs) completed by investigators, laboratory results, and other clinical assessments. The data management team reviews the incoming data to identify any inconsistencies, errors, or missing information. If they discover any discrepancies or issues in the data, they generate queries to request clarification or additional information from the investigators or study sites.
These queries are then communicated back to the sites or investigators through a formal process, typically through a data clarification form (DCF) or electronic means, to ensure that the data is accurate, complete, and compliant with the trial protocol and regulatory requirements.
Overall, the data management team plays a crucial role in maintaining the integrity of the clinical trial data, and generating and resolving queries is an essential aspect of their responsibilities.
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