Challenge # 23: L’ALCOAC, how to apply in monitoring !

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Good morning, everyone. This is Vanessa Montanari from the clinical research blog for Pharmaspecific. Today we’re going to look at a new topic, we’re going to talk about ALCOAC. ALCOAC is a cigle that was incorporated about two years ago into the ICH GCP R2. R2 is the latest version of the ICH GCP, since there was an R1 version that was created in 1996. Therefore, in the version that was roughly two years ago, this concept was added. So what I would like is for us to develop this cigle.

So, ALCOA. The first cigle is A: attributable. In fact, it is attributable. We must be able to find out who did what. So, for example, who wrote this in the medical file or who signed such and such a document, we must be able to find that information through the delegation log; with the list of the various people to whom we delegated the project, we must be able to find that information through the date and the initials of the person or the signature. So this is the first letter.

Then we have the letter L. So it’s legible. Legible, the data must be legible over the long term as part of the clinical study. So you have to be able to keep the data for a very long time. As you know, in clinical trials, data are kept for at least 15 years in France. Therefore, the data must be kept in the best possible condition if necessary. That’s why the data must be legible, and for that reason, for example, in the case of ECGs, sometimes on ECGs, the data can go away over time. So, on all objects that are made on paper. So often the best thing to do is to make a photocopy of that ECG and put a certified true copy in the file and keep it. That way, we know that if ever the data has to go, has to be erased, in any case we will have the certified true copy of the data. The best thing is to find the best solution so that the data cannot be deleted. But if ever, we are really in a situation where we can’t, that’s when you can make a certified true copy.

Then you go to letter C: contemporary, contemporary. Basically, you can’t backdate or postdate a data item. For example, you’re going to have a datum, the patient is going to sign. If the patient signs the consent, for example, he or she will sign on a date, the date that must be written in the consent and really the date on which he or she signed it. The dates that are entered in the study must really be the dates on which things happened.

O, the letter O, means original. The data must actually come from the original source. That is, the data must come from the first source on which it was written. Let me give you an example. If the doctor has a diary, and it is on this diary that he notes certain information, the data must be retrieved from this diary, not from a copy, a recopy of this diary. Because you know that when you copy something, often you copy things with error. Unfortunately, we are human and it’s often like that. So the best thing, and this is really what good clinical practice requires, is to recover what is called original data from the source file. A for Acurate. So the data has to be accurate. So, either the data that was written exactly. It has to be consistent with what that source file is exactly, with what that original data is. Finally, we also have the letter C: complete. So the data must be complete. When we say complete, that means that all the necessary information, all the training must be provided. For example, if you have a paper medical record and an electronic medical record as part of a study, the clinical research officer will have to check both the paper medical record and the electronic medical record for the patient. You’ll have to check both and see if there’s any data that’s in one and not in the other. Because the data has to be complete, so we’re going to come and look at the whole file. Then we can get all the data back. So the data will be complete at that point. We will also have to look at all the other files that are needed. If there is a file in the dermatology department, we will have to retrieve that file. We will have to look at all the necessary information and have all the data as complete as possible.

I hope this video has helped you. If you liked it, please put I like at the bottom of the video. If you want to know more about the clinical trial, you can go to the clinical research blog. The link is here. If you want to know more about our CRO Pharmaspecific, a CRO specialized in clinical research, you can go to this link. The website is here. You should know that Pharmaspecific has created a guide to help you better understand clinical studies.  It is a guide of about a hundred pages that is a feedback from our teams. You can download it at the bottom of the video. Thank you for watching this program, see you soon.

Bye, guys.