It seems that the latest submission from the MHRA on their GCP Forum has provoked a great amount of discussion and raised concerns amongst industry. What is it all about?
Well the MHRA have provided some clarification on the topic of retention of records. The wording in some of the applicable European Directives is a little ambiguous so the MHRA have tried to clear up this topic. They also provide some clarification about retention of electronic records, pointing out that “electronic records are acceptable under the regulations”. So far, so good.
However, the Forum post then goes on to discuss the digitisation of paper records, retaining in their place electronic copies. What appears to be causing most concern is the suggestion by the MHRA that irrespective of whether the scanning process produces certified copies in accordance with applicable regulatory requirements, there is an expectation that the original hard-copy records should be retained for a minimum of 5 years after completion of the clinical trial. They comment further that even after expiry of this 5-year period, there would be a requirement for “full verification that these data were complete, legible and verifiable as accurate copies of the originals.” And failure to do so would require production of the original paper records.
I fully understand some of the reasons why these comments are being made, due largely to the MHRA inspectors having come across some very poor practices with regards to document scanning. If they see poor quality scanned documents in an inspection, they are not going to be recommending that you destroy your originals! However, I find the whole tone of the comments disconcerting. And remember, there is NOTHING in the applicable regulations, directives or legislation that specifically requires retention of original records following production of a certified copy.
And therein lies the issue – are you producing a certified copy, per the requirements of the EMA and FDA? You see, if you are indeed generating a certified copy – an accurate and complete copy of the original document – there is no regulatory objection to you destroying the original records. I’ll say that again. If you have satisfied yourself that the digital copies of your original paper records meet the definition of the EMA/FDA for a certified copy, there is no regulatory requirement for you to retain the original documents.
A definition for a certified copy is provided in the draft ICH GCP Addendum:
“A paper or electronic copy of the original record that has been verified (e.g. by a dated signature) or has been generated through a validated process to produce an exact copy having all of the same attributes and information as the original.”
The document goes on to say:
“When a copy is used to replace an original document, the copy should fulfil the requirements for certified copies”.
Notice the wording? It says that a certified copy can “replace” an original document. That doesn’t mean “keep hold of the original just in case” …. it means “replace”.
What about legal admissibility? No problems here either. If you are generating a certified copy and are destroying the original as part of your normal business process, a copy cannot be deemed inadmissible solely by virtue of it not being the original. The authenticity of the copy may be challenged but for a certified copy, you would of course have a documented process, audit trails etc to support you.
So what am I saying? That it is always OK to destroy originals following scanning? No, I’m not. But what I am saying is that our industry is already extremely risk-averse on purely administrative matters. For issues that have the potential to impact patient safety or product quality, being risk-averse is appropriate. But we’ve been encouraged over the last few years by the EMA and MHRA to follow a risk-adapted approach to the management of clinical trials, especially where patient safety is not a factor. Rather than starting from the assumption that copies will be poor quality and you should therefore retain originals just in case they are needed, let’s start from the assumption that you are generating acceptable, certified copies. Quality by design! So, assuming that you have a well thought-out and validated process for generating certified digital copies, and you have a quality management system that gives you assurance of the completeness, accuracy and trustworthiness of those copies, you should not be dissuaded from destroying the original records as part of your normal business practice. We need to develop high quality process and then have confidence in our processes and in our technology to help them deliver maximum efficiency savings.
[Also posted on LinkedIn Pulse]