Things You'll Need:
- Folders
- Computer
- Document management software
- Database (e.g. Access)
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Step 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. -
Step 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. -
Step 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!). -
Step 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!) -
Step 5
Follow-up on your documents.
Set up a time for periodic checks and follow-up to retrieve missing documents. -
Step 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. -
Step 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.
Comments
luv2blog said
on 5/8/2009 There are several - Documentum, TrackWise, QPulse, Lotus Notes, just to name a few. You'll have to do your research and have the vendors come in and show you what their systems can do. Believe me, once they know you're looking, you will have plenty to choose from. lol.
merm said
on 5/7/2009 In regards to Step 6 ... Which document management software do you suggest that will allow me to do all the necessary tracking plus will allow me to scan records into a database?Thanks!
luv2blog said
on 8/21/2008 David - sounds like your company needs an audit! (smile) I can't tell you how many systems have gotten implemented after one of my visits!
mcorgan - you're right. I also meant to add something about email retention. People tend to forget that some business emails need to be retained in a certain manner. Even though the system is backed up, for clinical trials (CT), certain correspondences should be retained with the CT files.
Thanks for your comments guys!
mcorgan said
on 8/21/2008 Great tips for those dabbing their toe in the cold waters of document management. Step 7 should be a non-negotiable and maybe step 7.5 should include how one would go about securing presumably sensitive data. Where I work (insurance company) we have strict policies on record security and are constantly audited for compliance. Of course it is a public company but it is still best practice to have a basic security plan in place. Thanks for the info!
dsarokin said
on 8/21/2008 This is something we really need at our work, since we have the same sort of need for long-term, legally valid document retention. Of course, we don't do it! But we need it. Think I'll show your article to my boss.