2022-02-08T12:32:08.000Z

Consider the following scenario:

“A 2nd shift servant just started her shift, when she checked the book, she noticed the last dining costumer was not given the complementary chocolate, she quickly fixed the error by rewarding the customer with a piece of chocolate. When she notified her outgoing colleague of what she did, he responded that he already gave the chocolate, but forgot to note it on the book.”

In this situation the customer received two pieces of chocolate. One might say that is fine, not a big deal, two chocolates instead of one is a plus, right? What if this error happened in an in-patient ward where a patient was given two doses of a drug? That would be a real problem.

In both cases the error was “not documenting” an action, the results could be devastating and not always two pieces of chocolate.

What is GDP?

Good documentation practice (GDP) is the act of documenting an action or data. The documentation may take different formats, like paper or electronic, and need to be:

• Timely
• Legible
• Accurate
• Attributable

Do I need GDP?

Researchers and their teams are very experienced with their cell-based processes; they developed or repeated processes so many times and can perform them single handedly. Yet, documenting their research studies serve many benefits, including:

1. Standardize the work: By documenting your process, your staff can repeat it exactly the same every time which eliminates the inter-personnel variations in performance.
2. Train new staff: The documented process provides a starting training material to new members who want to learn specific processes.
3. Not repeating the same question: By documenting a study and its results, it serves as a proof of what had been tested so you may tackle new/next questions.
4. Accreditation: If your lab intends to be accredited, documented studies and processes would be among the 1st documents to be shared with auditors and surveyors.
5. Translatability: One of the most important benefits to GDP is your ability to translate your cell-based research to clinics, here you would first use your process to do a safety study and later as proof of principle. The cell-based processes are usually long, costly, and require expertise. If not documented properly you would be asked to repeat and show evidence of that. GDP saves you the cost of repeat, and better prepares your processes for translational studies.
6. Tech transferability: For your process to be transferred to another institution, or licensed to an investor, it needs to be well structured or documented. In fact, you would need GDP process to even publish your results, that stakeholders might cite, or consider to tech transfer or licensing.

Common GDP errors

For active documentation with multiple data entries, it is not uncommon to make a wrong entry. It is acceptable to make mistakes, but fixing them need to observe the GDP standards. Often with good intention, one might do a simple act and assumes it is harmless, while in fact it is not acceptable practice. Below are three common errors to avoid in fixing errors:

• The write over: when trying to correct a wrong entry, make a line though to the wrong entry, then write the correct entry next to it. For example: this 16.5e6 is enough so the original entry is still legible.
• Obliterate: is to cross over the wrong entry many times to the extent the original entry in no longer legible.
• Missing signature: when correcting a wrong entry, make sure you initial/date next to the correction.

There is no need to regret documentation mistakes, it is all normal for any active laboratory. All you need is to properly correct them, then rearward yourself with a piece of chocolate.

Let us know if we missed anything, or if you would like a specific subject to be discussed, write to us.

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About the author

Naseem Almezel, earned his MSc degree in Cellular Therapies in 2010, since then his career focus is to support Bone Marrow Transplant and Oncology programs. Naseem likes to work in the lab doing translational research, or in the cleanroom doing GMP production. When he is not working, Naseem likes to read and to spend time outdoors. Find more about Naseem here