How to Create FDA Auditable Source Documents

The source documents you generate for your clinical trial can either make or break a new drug. Keeping in mind that it takes the average drug 10 - 15 years to reach the New Drug Application stage (i.e. marketable to the public), poor documentation can make it impossible to reconstruct the events of the clinical trial, if needed. The best rule to remember is that when completing clinical trial source documents (i.e. clinical trial records), someone other than you will be reading them and they should be able to fully understand everything that happened without asking any questions. Your source documents should tell a story - a story about how you run clinical trials at your research center. There is a good chance that you will be gone on to bigger and better things when these source documents get audited. If that is the case, you will be unable to provide clarification or explanations to the auditors. Read further to see what make clinical trial source documents auditable for a sponsor and the FDA.

Instructions

Difficulty: Moderately Easy

Things You’ll Need:

• Basic Good Clinical Practices knowledge

1. Perception is Everything!
   
   I am sure you have heard the expressions “First impressions are lasting impressions” and “perception is everything”. Do not take these expressions so lightly. From the minute the auditor enters the premise, their eyes and mind are at work and they are drawing conclusions. They are assessing your neatness and your organizational skills. If the office looks junky, it could instantly be concluded that your source documents will be incomplete and disorganized, too. (And I have yet to be wrong!) Auditors do not like the “Go Fish” concept when auditing. Organize the work space and the clinical trial source documents and other records. It doesn’t matter that you know where everything is. It is “how it looks” to the auditor that counts. Perception counts!
2. Have Required Training!
   
   Good Clinical Practices require that “complete, concise and accurate” information be reported to the sponsor. While auditing, I read a source document where the Clinical Research Coordinator wrote “the subject was in the hospital with ammonia”. Well, the first thing that sentence told me was the Clinical Research Coordinator is not medically trained. A medically trained person would know the word was “pneumonia” and not “ammonia”. The second thing it told me was that the doctor was not looking at the Clinical Research Coordinator’s work or he or she would have corrected it, (at least it should have been corrected). If you come across a medical term that you can’t spell, use a medical dictionary or the internet to get the right spelling. Just reading that one document, I picked up two significant regulatory violations - all in less than 5 minutes.
3. Write Clearly!
   
   For years I have heard the saying “doctors have the worst handwriting”. For most of the doctor’s I have audited, this is true. I have also come across some Clinical Research Coordinators with awful handwriting, too. Take your time and write clear notes. Proofread your notes and see if they make sense. Also, if it isn’t written clearly, you might not be able to prove your point if the company (or you) end up with legal issues.
4. Explain Corrections and Errors
   
   No one is perfect and auditors and inspectors expect to see mistakes. However, your mistakes should be minimal and an explanation for all changes to data (e.g. birth dates, lab results, study entry criteria) should be recorded next to the changed item. The Principal Investigator should approve significant changes to medical data or case histories made by the Clinical Research Coordinator.
5. Stop with the Shortcuts!
   
   The terms you use in your office or clinic might not be a common term in the clinical research industry. For example, writing OAW might be clear to you and the staff at the site, but an auditor will not know that you mean “Once a Week” if there is nothing clarifying the abbreviations. Stick to well-known abbreviations and avoid shortcuts. If you do use abbreviations, consider creating a list to provide to auditors and Clinical Research Associates who might read your source documents.
6. If it isn’t written, it didn’t happen!
   
   No truer words were ever spoken! There is no way to confirm that you followed protocol if you are not writing it down. For example, regulations require that all clinical research subjects sign an informed consent form before any clinical trial activity is performed. There is no way for the auditor to verify that this was done if it isn't written in the source documents. This is especially difficult when the consent form and the clinical trial start date are the same.
7. Complete Source Documents in a Timely Manner!
   
   There is no acceptable explanation when an auditor finds source documents are incomplete or continuously incorrect. If a subject visited the clinic in January the records should be completed before the end of the week, not some time in March! It is unacceptable to have documents outstanding months after the visit. That will get you cited by a sponsor auditor and the FDA.
8. Information on Good Clinical Practices and creating good clinical trial source documents can be found using the resource section below.

Tips & Warnings

• Clear and concise documentation could keep you from getting a Warning Letter or FDA-483 citation from the FDA.