Doc Juggling Made Easy: Keep Studies on Track

Prelude Modules: Document Management

Document management within a study can be complicated and tedious. We know! With so many sites, personnel, and patient documents, something is bound to get lost or go past its due date once you are weeks into your research. And a filing cabinet won’t cut it. With Prelude’s Document Management module, you can easily keep track of all your study-related documents, streamline your document review process, and ensure that your team has access to the right documents at the right time.

Do I Need a Document Management Module?

Let’s say you’re working on a clinical trial with multiple sites. And, you need to keep track of site questionnaires, personnel medical licenses, patient clinic records, …the list goes on. Without a proper document management system, you will struggle to keep all these documents organized and accessible. 

With Prelude’s Document Management module, you can easily manage these files – anytime, anywhere. You can store study level documents. You can specify a list of required site, personnel, and subject specific documents as well as supplementary data for each (e.g., status, approval date). For personnel files, you can configure requirements based on study responsibilities. You can create custom workflows with scheduled notifications to ensure that documents are uploaded, reviewed, and approved by the right role at the right time. Version control allows you to see past versions of your files. And ad-hoc file storage is available for supplemental study information. 

Let’s break down how this works. 

Initial Configuration 

• In Prelude EDC, required documents may be specified for:  

• • The Study/Project (e.g., protocols, amendments, SOPs), 
  • Sites (e.g., IRB approvals, lab certifications), 

• • Site personnel (e.g., CVs, certificates) based on study responsibilities defined within Prelude EDC, and 
  • Patients (e.g., vital signs, hospital transfer records). 

• Supplementary data for each document may also be specified (e.g., the date by which the document needs to be reviewed or the document status). 
• Notifications can be configured to trigger emails to specified roles when a document is uploaded or based on a date (e.g., 5 days before expiry, send an email notification to the study coordinator). 
• Once the initial configuration is done, a comprehensive list of all required documents for each site, personnel, and subject is automatically generated making it easy to upload and manage documents. 

During the Study 

• Required documents can be uploaded, viewed, and marked as reviewed. 
• Study personnel coming aboard can view and upload only those documents required of them based on their responsibilities. 
• All uploaded documents are available in a centralized read-only repository with past and current versions.
• Summaries detailing uploaded and not uploaded documents can be pulled to spot missing data files easily.  
• Documents no longer needed can be marked as obsolete so that only relevant documents are visible from that point on. 
• Ad-hoc electronic “binders” can be created for additional data storage. 

Managing study documents doesn’t have to be daunting. With Prelude’s Document Management module, you can streamline your processes and keep all your study-related documents organized and accessible. 

Ready to get organized? Let’s talk.