Whether on the site or at the sponsor level, we are asked to use Good Documentation Practices in clinical research.
One might assume that a quick visit to the FDA website would produce the list of best practices. However, there is no Code of Federal Regulations for clinical trial documentation. Here's a closer look at why Good Documentation Practices (GDP) are so important and some important guidelines to follow.
Why Good Documentation Practices Matter
As we like to say at IMARC, "if it wasn't documented, it wasn't done."
Good clinical trial documentation offers a record for your team, third-party auditors and the FDA to review so you can be sure your trial complies with all applicable regulations and is on track for approval. It provides a snapshot of everything that has happened throughout the course of your clinical trial. Failure to maintain adequate records is one of the most common violations cited in FDA Warning Letters year after year.
Additionally, good documentation offers a paper trial (or ideally, a digital record) of any protocol changes you have made and why.
For instance, if your clinical trial began with in-person monitoring visits and you have shifted to remote monitoring, you need to make note of this so there are no discrepancies later.
Best Practices For Clinical Trial Documentation
The following are some good documentation practices in clinical research, as listed by the Dana-Farber/ Harvard Cancer Center. They should be applied throughout the course of a clinical study.
Maintain adequate records (21 CFR 812.120 (a))
Maintaining adequate records is fundamental to good clinical trial documentation. Yet year after year, we see FDA Warning Letters note “Failure to prepare and maintain adequate and accurate case histories," “No documentation of protocol-required procedures: no proof labs were completed" and “Inconsistencies in source and CRFs.”
Don't let it happen on your watch!
Source documentation is where the information is first recorded (ICH GCP E6 1.52)
That’s right! It doesn’t matter where it’s written — just where it is first recorded. A colleague recently told me that as a research coordinator, she was required to enter all “source” data into the medical records. If it wasn’t in the medical records, it didn’t happen as true source were medical records only. This is not what ICH GCP says. ICH GCP states true source is where the information is first written regardless of if it’s the medical record, a source worksheet or a Post-it note.
Data must be verifiable and follow an audit trail
Documentation should tell the whole story. It should also not contradict any other source data. Otherwise you could receive a warning letter that states, “source documentation and CRFs contain discrepant information.”
Use ALCOA-C documentation principles
FDA auditors are taught to use ALCOA-C as a guideline during inspections. This is important for those in clinical research and quality assurance professionals.
ALCOA-C is an acronym and a mental checklist you can use to determine whether your clinical trial documentation is sound.
It should be attributable, legible, contemporaneous, original, accurate and complete.
Make corrections to source documents carefully
In a 483 warning letter, one investigator was cited for “CRFs being incomplete with various cross-outs and changes by multiple authors, and an occasional use of white-out.” If you need to make a correction, be sure to initial it. Never use white-out!
Never destroy original documents
Failing to maintain documents evidencing informed consent is another misstep that can result in an FDA Warning Letter. It's a good reminder to take credit for your work and document everything.
Keep study records secure, yet accessible
It’s important to know who has access to study records. These should be limited to the study research team and kept in a safe area away from public access. Remember anything with patient information is subject to HIPAA and HITECH rules.
In another great article, Good Documentation Practice in Clinical Research suggests a reason for so many FDA 483 warning letters for poor documentation is due to lack of training and experience in good clinical practice and good documentation requirements.
If your team needs help establishing best practices for clinical trial documentation, IMARC can help. Our experienced monitors can review your standard operating procedures or review your clinical trial documents in person or remotely. Don't wait until you receive an FDA Warning Letter to examine your documentation practices. Contact us today.
How does your company or site enforce good documentation practices in clinical research? Please share your experiences with us.