An FDA audit can be one of the scariest and most difficult events a research organization can face, so it is important to be as prepared as possible for when that day comes. This includes ensuring that you are correctly storing and managing your documents. The way that documents are handled, managed, and stored can provide auditors a strong indication of the level of quality at which the study was conducted. While many different components need to be in place to successfully pass an audit, managing your trial documents properly is a gigantic step in the right direction. In this article I will discuss 4 tips to help improve trial document management.
Create a Physical Inventory System
When it comes time to move older study documents from the file cabinet into storage boxes it is critical to both, conduct an inventory of what documents you have, and a detailed filing system so you can find the documents again in the future should you ever need them for an audit or any other purpose. First, it is critical to do an inventory prior to putting physical documents into storage because this allows you to ensure you have what you think you have in terms of documents. It also gives you the opportunity to track down missing documents before everything gets put away, as the likelihood of correctly filing a missing document after the rest have been put in storage is low.
Secondly, it is critical to create an organized filing system so it is easy to determine which documents are in each box. This will help immensely if you ever need to pull out the documents during an audit. A good tip is to print a physical copy of your inventory list and where it is located so you or one of your staff can documents quickly.
Store both Digital and Physical Copies
While in the previous section we discussed how to manage your physician files, it is also important to maintain a digital copy of your trial documents. There are many ways to store trial documents digitally. Some storage options include document management systems, CTMS systems, EDC systems, central databases and many others. Having an organized and auditable document management tool will go a long way in making sure that a document is never lost.
Track Document Versions
Throughout a trial there may be several different versions of a particular document that is used. A new patient consent form or case report form may be needed at some point during the middle of a study. While making the switch to a new version is okay, it is important to ensure you keep copies of the old versions, as well as note when you made the transition to the new version and why you made the change. Doing this will help auditors understand why your organization did what it did.
Automatic Document Notifications
Keeping track of documents that expire or need a signature is a very difficult task to manage. With all of the other items going on during a trial it may seem difficult to keep track of what expires when, or what documents need signatures. A good way to help manage this is to use a document management system, like a CTMS, to help you do this. A good document management tool will allow users to get automatic notifications when documents need some action taken on them. A good practice is to set up notifications to alert you 2 months prior to its expiration, this allows for adequate time to renew or update the document before it expires.
Document management is a time-consuming and difficult process, but putting in the time and effort up-front, can really save your business in the long run. Adequately managing trial documents can make even the most frightening events, like an audit, seem a lot less scary.