The process of starting a multi-site study is significantly more involved. The coordinating center is tasked with gathering legal documentation from a network of locations that may be using various document management programs. The personnel in the coordinating center will spend hours making sure each area has all of the necessary papers if some sites use paper binders and others use various web drives and drop boxes. For this reason, having software that can be used across multiple sites and that the supervisory center can access is beneficial. The clinical research organization can log in and view all of the Veristat sites’ documents in one location if all of the research sites are using the same program.
Here are a few ways technology can assist with the regulatory filing during the beginning of the study:
Easily creating and updating documents
The clinical trials team can easily prepare documents with templates when using electronic ISFs. Florence further provides fillable forms, allowing you to generate documents online without printing, scanning, or uploading. Using an electronic method makes document updating simpler. With central document linkage, you can make changes to one document and see those changes appear throughout all of the system’s storage locations for that document. A document will therefore instantly update in both locations if a site updates changes to one and its sponsor stores the same document in a different folder. By ensuring that CROs, sponsors, and coordinating centers have the most recent copies of the papers for their sites, and promote compliance.
Managing priorities and keeping projects on track
Even seasoned clinical researchers can also become overwhelmed by the sheer volume of paperwork, papers, and signatures required for regulatory filings. You can assign tasks to individual team members using the eClinical software, allowing them to log in and see which documents need to be reviewed or signed. With the help of this program, you can also add due dates and placeholders to let staff members know where to upload particular papers and which duties should take priority.
Setting up trial logs
If you’ve ever worked at a testing facility, you’ve probably encountered perplexing trial logs written in several people’s handwriting. So that research staff members aren’t left wondering who is in charge of a certain duty during start-up, logs are kept organized and simple to read by setting them up online. When using eLogs, you can view the most recent information while simultaneously looking back at earlier iterations of the log. The study start-up and the study itself are made easier with clear, readable logs.
Gathering electronic signatures
For principal investigators and clinical research workers, being able to sign documents from a phone or computer during the study start-up procedure can save a lot of time. Principal investigators can’t spend a lot of time signing paperwork since they are too busy conducting research and caring for patients. They can sign using electronic software from any location that suits them, whether from a couch, or even a train. A single webpage will have a list of all the jobs and requests. However, electronic signatures must adhere to 21 CFR Part 11 regulations. It’s also crucial to use software created especially for clinical trials rather than software created only for electronic signatures for this reason.
Technology can assist sites in identifying areas where research start-up delays occur. Also, many software can generate reports indicating how long it took individuals or organizations to produce papers. Also, the system can find a solution to make study start-ups go more quickly.