From Study Documents to Training Requirements: The Advantages of Automating Training Preparation

Introduction 

The process of uploading documents and creating training requirements is integral to the role of a Clinical Trial Manager, whose primary responsibilities include ensuring that clinical trial teams and site personnel are adequately trained. The traditional method of manually uploading and preparing training content can be time-consuming, whereas automated integration from a document management solution presents a more efficient alternative. This blog post delves into a comprehensive comparison of these two approaches, providing rough time estimates for each process, and highlighting the potential time and cost savings associated with automation, especially in the context of clinical trial training management. 

Typical Workflow Design for a Medium-Sized Clinical Trial 

Training Document Preparation 

The first step in the upload process involves getting the documents ready for upload. This is a crucial step as it ensures that the content is fit for use. For the average clinical trial, document preparation can include uploading information from anywhere between 50 to 200 documents. This can take anywhere from 15 to 30 minutes per document, depending on their complexity.  

Document Upload 

Once the documents are prepared, they need to be uploaded to the Learning Management System (LMS). Locating, verifying, and adding additional metadata (effective date, for example) takes about 5 to 10 minutes per document. 

Course Creation 

After uploading, the next step is to create the corresponding course so that it can be assigned to role-based training groups, thus integrating all the relevant information as a training requirement for Learners. The time required for this can vary significantly, ranging from 15 minutes to an hour, depending on the complexity of the content. 

Content Organization 

Next, we need to organize the content into a comprehensive learning experience, including the necessary knowledge check and attestation. The time requirements for this step can vary greatly, ranging from 30 minutes to several hours.  

Testing and Quality Assurance 

Before the course is published as a training requirement, it needs to be tested to ensure everything is working as it should, and the content is displayed correctly. This process takes about 15 to 30 minutes. 

Total Time 

On average, for a straightforward case, the entire process from document preparation to launch can take approximately 1.5 to 3 hours. However, this can increase significantly for more complex content. 

Improving the Training Requirement Preparation with Interoperability and Automation.

You can save a considerable amount of time if you automate training requirement preparation with an interoperable solution: 

Integration Setup 

The initial setup of an automated integration system can be time-consuming, requiring several hours to a few days to complete. However, this is a one-time investment.  

Automated Document Upload 

Once the automated system is set up, document upload becomes almost instantaneous, saving a considerable amount of preparation time; anywhere from 5-15 minutes per document.  

Manually uploading the documents is far more time consuming over the course of a trial. In clinical development time is money – the longer a staff needs to spend manually uploading data and documents, the more they will need to be compensated. Let’s look at a pragmatic example, using the clinical Trial manager as an example.  

What might this look like in practice? Let’s explore the following case study regarding a clinical trial manager who needs to establish a training workflow.  

The Persona: 

As a Clinical Trial Manager, assigning study-specific training to clinical trial teams and site personnel through the LMS is critical. It is the Trial Managers responsibility to ensure that the team is adequately trained for each trial’s specific requirements. 

The Challenge: 

The biggest challenges here are associated with manual document upload and converting content into training requirements. For a medium-sized clinical trial, generating 50 to 200 or more documents, the manual process can take upwards of 100 hours, translating into significant labor costs. Clinical Study Managers, with an average hourly rate of $58, can incur costs of around $5800 just for document uploads. 

The Solution: Time and Cost Savings with Interoperability of a Document Management System and a Learning Management System that leverages automation 

The adoption of an automated integration system from a document management solution directly addresses this challenge. Not only does it significantly reduce the time required for document uploads and course creation, but it also results in considerable cost savings. The time savings become even more significant when managing a larger volume of content over multiple clinical trials. 

Conclusion: 

Manual document upload and course creation, while straightforward, are time-consuming and costly, especially in the context of clinical trial management. Automated integration presents a compelling alternative, offering significant time and cost savings in the long run. By investing in an automated system, Clinical Trial Managers can streamline their workflows, ensuring that their teams are adequately trained and ready for the challenges of each specific trial, all while saving time and resources.