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Good morning, everyone. This is Vanessa Montanari from the clinical research blog for Pharmaspecific. So today we’re going to take a look at another topic. It’s the audits. Audits, by extension inspections, but audits, actually. How to do a stress-free audit. How you prepare for an audit as a clinical research associate. Item one, the investigator binder needs to be up to date. So you really need to make sure that the binder is up to date. So, that’s why throughout your monitoring, you have to have your checklist and that checklist has to be up to date because at the time of an audit, the auditor, that’s one of the things he’s going to look at. This is the investigator workbook to see what is in your workbook. Is the binder up to date. Does the investigator have all the documents.

This is a rule in ICH GCP 4.9.4 and ICH GCP 8.2.18. The investigator is responsible. Be aware that the investigator is responsible for his or her Investigator’s Filing Cabinet. If there is a problem with this workbook, he is responsible. But you, as the CRA, will help him by bringing the necessary documents, showing them what is missing, etc… but it is true that they are in principle responsible for the binder. And sometimes the site study coordinators think that it is the clinical research officer who is responsible for the binder but no, it is the doctor and therefore by delegation it is up to them to take care of it. At the binder level, some documents are the task delegation form, CVs and training forms. So you have to make sure that these three points are aligned. You have the person on the delegation log, you have an updated CV, dated and signed. You also have that person’s training certificates. This person has been trained in the study. This is something that will be verified by an auditor. You have to show that the person has been trained. You have to refer to ICH GCP 4.1.1 and 4.1.3 and 4.2.4 to see this point. You must ensure that the AE and SAE are properly documented, filed and reported. For example, make sure that for SAE, if they were sent by fax or e-mail, that the SAE is printed, that the fax is hung up, or that the e-mail sending the SAE is hung up, because this is something the auditor can check. The auditor can look to see if the EAS was actually sent. You have to prove that it was actually sent. You also have to for SAE, well documented SAE.

Show the relationship to the treatment under study. Is the serious adverse event related or unrelated? It must be written in the medical record. So if it hasn’t been written down, you have to check with the investigator but use the adverse event worksheets to be able to avoid that certain data are not in the medical record or you can check with the investigator to make sure that it is documented as well as possible. But the information really needs to be there. So, in France, we use the French good clinical practices which are in fact in the decision of 24 November 2006 in point 8.3.16. So, there are other little rules to ensure a serene audit in terms of deviations. You are going to see a certain number of deviations at the level of the centre. It is important to know that the deviations must all be explained. If there is a deviation, the deviation must be explained and possibly explain what has been put in place to solve the problem. So, generally speaking, you write it in the report, but on site, on site, the deviations must be respected. So, what has been done for a number of years by a number of CROs is a deviation form, which is the equivalent… when you have ISO9001, it’s the equivalent of a non-conformity, where you actually write down what happened and the actions that were taken. So, for every deviation, it’s actually the equivalent of a non-conformity form because a deviation anyway is a non-conformity. So you have to have that type of form. Finally, the investigator must have this type of form, either the investigator already has it in his procedures, since the centres that normally conduct clinical trials must have their own procedures for clinical trials in the hospital… So, either they have this form or they don’t, and then it’s up to you to help them and to propose something to them. In terms of consent, where you have to be very careful is that the procedures for obtaining consent are well documented and that a copy has been given to the patients.

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This information must be noted in the medical record and this is a very important point. So, the collection process, what is it? It means, for example, that the patient was able to ask all the questions he or she wanted, that the patient had all the time he or she needed to think about it, that he or she had all the time he or she needed to make a decision, that the signing of the consent took place before any study procedure and that a copy or a copy was given to the patients. That information needs to be in the medical record. So you can refer to the decision of 24 November 2006, the French good practices, including point 4.8.8 and point 4.8.6, to see what I am talking about. So, another important point is in relation to electronic and paper medical reports. So pay close attention to this part, because an electronic medical report must be signed and dated by the investigator in the same way as a paper report must be signed and dated by the investigator. So if you have an electronic medical record, that medical record must have an audit trail. So, an audit trail is an audit trail. It’s something that allows the auditor to check the medical record, who did what on the medical record. Who changed what. When did an investigator sign off on the report. That kind of information, he has to be able to see what happened. Well, in principle, in hospitals, large hospitals, well-known hospitals, often they’re already well established, they do clinical research. It’s already been put together. But maybe in somewhat smaller centres, maybe it’s not applied yet.

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So, a report typed on a secretary’s computer and in the computer, a word report, is not a reliable electronic report in the case of clinical trials. For this type of report, you have to print it out and have it signed and dated by the investigator. If not, if you have an electronic medical report, you must make sure that there is an audit trail and that it can be traced. You can’t do that with word. Also, think about all the password, password and login details. So, make sure that each person has a login and password, that some people don’t sign up for others or that kind of thing. You have to make sure that all these points are in order. If you want to know more about the point I’m talking about, you can go to the FDA 21 CRF PART 11 text, which is the text that talks about electronic reporting and electronic medical records. It’s a text from the food and drug administration in the United States. If you are working with American or foreign sponsors who need to file their drugs in the United States, you will surely have to use this type of text. Another important point that a listener might click on is the recovery of personal data.  So, be careful about the recovery of personal data. As I said in previous videos, ethnic origin is not to be recovered, if it is explained in the protocol. If it’s not explained in the protocol, avoid retrieving that information and sending it abroad, and in addition to that, the patient must be aware in the consent that you’re going to retrieve that type of data about him. So that’s also something that’s generally done, which is verified by the CRAs, which are responsible for regulatory submissions. But you, as a CRA monitor, must also be aware of this and you are able to verify this information. Normally, there is a section on personal data in the consent form, and if ethnic origins are collected, this must be specified to the patient. If not, it’s not allowed. The patient has to approve that you retrieve this ethnic data. To make it easier to understand the centre and the centres’ records, you can make notes in the file, for example.

So don’t abuse the notes in the file. A note to the file is an explanatory note that will explain a point. For example, in the investigator’s binder, a document is missing, it will explain why this document is missing. So there it is, it’s a document, it’s a note signed by the investigator. It’s best if it’s on hospital letterhead. That way, you explain a little bit about what happened, how it happened, how things are going. Last but not least, don’t hesitate to make your listener’s life easier. For example, you can create tools that you can present when he or she arrives. For example, the different versions of the applicable documents, consent, protocol, their approval at the ANSM, at the PPC. So, it is true that it can take time but it facilitates his work and even facilitates yours because at the time of the audits, it will help you to do your checks, your verifications. Auditing is something that a lot of people see as very stressful because they feel evaluated. But, I think you have to look at it in a different way. You have to see it as a way to improve yourself and to be better. Because in order to evolve, you have to improve. So, auditing should be seen in this way and you will take it much more serenely. The auditor is there to be able to see what is wrong and help us to better understand things. Within my company Pharmaspecific, we decided to have an ISO9001 certification precisely for this reason. Because I wanted my team to be able to use reliable procedures, to make sure that these procedures are followed and to make sure that we work and improve the quality of our work day by day. So for me, it’s something that’s very important and for me, it’s important to improve day by day. I recommend that you have the same state of mind when it comes to audits.

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I hope this video helped you. I hope this challenge has helped you and I thank you for following us. If you want to know more about clinical research, you can go to the clinical research blog. The link is here. It’s a blog that I created five years ago because there was no equivalent in clinical research in France and I wanted to be able to help people who want to enter clinical research, people who are already clinical research attachés or project managers in clinical research, clinical research managers as well. So, if you want to know more, don’t hesitate to go to this link. If you want to know more about Pharmaspecific, our CRO specialized in clinical research.  The link is here. Pharmaspecific is a CRO that I did ten years ago. So this year will give ten years to this company. It’s a multi-faceted company. So, we do project management, monitoring, we provide site study coordinators, we do regulatory submissions for foreign clients, foreign CROs but also French CROs who need us, big foreign CROs in France who also need us. One activity that we do that you may not be aware of is the reimbursement of patient fees. So, in fact, when a patient participates in a clinical study, the pharmaceutical laboratory does not have the right to recover his personal data and, on the other hand, the laboratory must reimburse the patient in the context of the clinical trial, since social security does not reimburse the costs related to clinical research. So our role is to be the intermediary between the patient and the laboratory and to reimburse the patient for the costs, the funds are brought to us by pharmaceutical laboratories. So we specialize in this service since 2013. So, if you are interested in this type of service, do not hesitate to contact us. I would also like to tell you that Pharmaspecific has created a complete guide to help you better understand clinical trials. It’s a summary of my team’s experience of about a hundred pages. So, if you are interested, you can take the link below this page. Thank you for everything, for following us. I hope to see you soon in an event by phone, by email on the networks. See you soon anyway.

Goodbye, see you soon.

Si tu as aimé cet article, je te remercie de « liker » ou de partager avec tes collègues et amis Attaché de Recherche Clinique :)


  • marine M dit :

    Les données sont conservées en base active jusqu’à signature du rapport puis font l’objet d’un archivage.
    Combien de temps mets tu ou conseilles tu pour faire cet archivage après la signature du rapport? Cela fait partie des SOPs de chacun mais cela varie tellement…Je me demande quel delai maximum serait acceptable ? 1an?

    Bien à toi

    • Vanessa Montanari dit :


      Je dirais sans attendre car il faut éviter de perdre des documents.
      Bon courage,


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