How to Develop and Implement an Effective Document Management System

It takes a company a minimum of 12 years before a newly discovered drug or treatment is available to the public. Clinical trial documents may not be requested for review by the FDA until years later. Because it is such a long process, it is essential that the sponsor develop and implement an effective document management system. Record retention is also required for the clinical investigator and the Contract Research Organization (CRO) assisting with clinical trial conduct.

Things You'll Need

• Folders
• Computer
• Document management software
• Database (e.g. Access)

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Instructions

• 1

  Draw or write out a plan.

  You need a plan. A few things that you must know before starting your clinical records management programs is exactly 1) what needs to be maintained, 2) how long it needs to be kept, 3) how you plan to keep it and 4) where you plan to keep it. A good place to start would be the Good Clinical Practices for Industry (GCP) guidelines that tells you the 26 records required to be kept. Once the plan is developed, change it to a Standard Operating Procedure and get it approved.

• 2

  Check your budget.

  If you are a small company, I can tell you now that Quality Assurance will be at the bottom of the totem pole when it comes to shelling out monies so find out how much money you have and that will determine if you are going to implement a paperless system or a paper-based system. Depending on the size of the clinical trial, a paper-based system might be more economical. If it is a large multi-centered clinical trial, I urge you to convince management to invest in a document management system. They will be real grateful for that system later.

• 3

  Develop a paper-based

  To develop a paper-based system, order folders. Label the folders with the 26 titles listed in the GCP guidelines. I recommend you get assorted colors so you can color code the system as much as possible. For example, all adverse events from a site can go in a red folder. All medical licenses and resumes in a blue folder and so forth. If you have more than one site, you will need to create 26 folders for each site (now you see why you want that document management software!).

• 4

  Track your documents.

  You will need to track the records coming in and sent out. For example, you will need a list of all doctors who have sent their financial disclosure forms to the sponsor. Each time one is received, enter the name of the doctor and the date receive, and then file it in the appropriate place. Do this for each piece of paper that comes in. (I bet you are beginning to really understand the need for that document management software right about now!)

• 5

  Follow-up on your documents.

  Set up a time for periodic checks and follow-up to retrieve missing documents.

• 6

  Electronic records management system.

  There are many document management softwares available so do your homework before making the purchase. Ensure the software has a built-in, unalterable audit trail. Make sure the software is validate-able, meaning security can be implemented, enforced and tracked. If you can not get a document management system, use Microsoft Access and develop a database. Remember, your main need is tracking. You must track your documents regardless of your system - paperless or electronic. A system that allows you to scan the records into a database and link them is great to have but not required. I do recommend that a pdf file be created of all the records coming in. The pdf will need to be a certified copy of the original. Maintaining the documents is your only requirement. If using an electronic system don't forget to back up the records and occasionally perform a restore to ensure they work.

• 7

  Implement a Disaster Preparedness Plan

  Yes, you need to make sure that if anything happens to the building where your tapes or records are stored, that a second copy is available. Places like California where earthquakes typically occur ensures a copy is in a bank vault or backed up to a server on the East Coast. Make sure that more than one person can access the disaster backup copies, if needed.