Informed Consent Forms (ICF) and Patient infrormation Sheet: 10 Tips to acheive your goals

If you need to prepare an informed consent for for an ethic committee in France, contact us www.pharmaspecific.com Transcription : Hello everyone, this is Vanessa Montanari from the clinical research blog for Pharmaspecific. Today, we will talk about consent and the information note I will give you 10 tips to succeed. But first of all, I would like to tell you that through Pharmaspecific training, we have created kits so that you can carry out your consents and information notes in a serene manner. So, what will you find in these kits? You will find consent models for all types of situations: emergency situations for children, classic situations for an adult … you will have several types and many more besides. Several types of situations. Next, you will find a guide in which we will explain how to write your consent. Paragraphs, examples of sentences to put in your consent, the regulatory texts that must be in your consent and in your information note. You will not find this kit anywhere else, at least not in the French-speaking world. So, now, I am going to give you the 10 tips to make your consent and your information note a success. First of all, at the level of the police.  The font must be easily decipherable and that’s why it must be at least size 12. If it’s about elderly people, you can even go up to 14, that’s my first piece of advice. My second piece of advice is that the terms used should be simple. If you have technical terms and abbreviations, you should explain everything the first time you use them. The consent and the information note must be clear to the patient. Third, the letter must be adapted to the category of people you are addressing. If you are writing to a 6-year-old child, you will not be able to speak and write in the same way as a 15-year-old child, or a parent of a child, or an elderly person. So you will have to adapt. The fourth point is language. It must not be anxiety-provoking. It is preferable that you use the conditional and the subjunctive when you talk about anything that is risky for the patient. Fifth, the consent form and the information note should be paginated so that the person who is going to open the consent form and the information note will need to know how many pages you have. Therefore, located on the first page of 15 pages, it should be marked 1 out of 15. You must also put the name of the study, the version number, the date of writing of this consent template and the terms informed consent form; if it is an informed consent form; or briefing note; if it is a briefing note. You must indicate this in the footer. Be aware that these documents can be separated. You can either separate them and then paginate them differently, or you can combine them into one document. Then it will be as the footer title of the Informed Consent Form and Briefing Note. Sixth, you can ask the patient to initial, but it is not always mandatory. Be aware that some Ethic committee in France s ask for it, some require it and some will refuse. You can find this type of information in our kit. Seventh point, avoid certain formulations that could embarrass the patient. For example, we don’t say if you get pregnant. This word has a negative connotation that is not well perceived in a consent. It is better to use a term such as if you are pregnant. You should also avoid words that refer to a sensation, a feeling. I’ll give you an example. In a sentence such as a needle will be gently inserted into your arm. In reality, you don’t know if the person who is going to take the sample will really be delicate and delicacy is something subjective. So some patients will be in pain, others will not. So you have to avoid all these words of sensation in the informed consent and in the information note. Eighth point, at the level of the information note. Since it is intended for patients, it is the study physician who addresses the patient. It should be written in the second person. The consent form, on the other hand, is the patient’s attestation. The patient agrees to participate in the study. Therefore, it must be written in the first person. “I understand that …”. So, you should know that to help you write this consent, you can find in the MR001, sample sentences to help you write your consent. The MR001 is the CNIL’s commitment to compliance. It is therefore a document that can also help you. Tenth piece of advice, make sure you reread your protocol and your observation notebook before reviewing your consent. Make sure that each examination performed is described and that the patient is informed of all the risks. You can also use the Investigator’s Brochure. So, in general, the informed consent form and the training note are written in French. It is mandatory that they be written in French. Sometimes, when you are in an international study, you will receive documents in English. These documents will be translated and you will adapt them to French regulations and to the expectations of the French Ethic committees. That’s it, so I’m finished for his little advice. I hope that they will help you to write your consent and your information note. See you soon!

Which profession is the most suitable for a PhD?

Transcription : Hello everyone, this is Vanessa Montanari from the clinical research blog. Today we are going to talk about a new subject. Which job in clinical research is the most suitable for a doctor of biology?

So, there are currently two purely clinical research professions that I would say are the most suitable for a doctor of biology, and another profession that is a little bit on the borderline of clinical research, which I’m going to tell you about, which could also be adapted to a doctor of biology.

So first of all, there is the job of Clinical research associate, and therefore the job of quality controller. So the doctor of biology is going to use his biological knowledge and all his rigor to be able to carry out controls in the context of clinical studies.

He can also become a project manager in some countries and also in some… for example in a hospital, he can no longer easily access this type of position, which is the position of project manager.

Afterwards, for the doctor in biology who likes the bench, he will be very disappointed by the job of CRA  since it is a job where there is no bench at all but only paperwork. So you really have to be aware of that.

Then there’s the job of medical writer. So as a medical writer, you have to write consents, investigator brochures, protocols, articles. So it’s a writing job. The doctor of biology will use a good part of his knowledge, of what he learned during his doctorate, and if he has done a post-doc it will help him a lot. So I think that the job of medical writer is one of the most suitable because the doctor of biology will really use some of what he did in his doctorate and post-doc.

Then there is another job that can be interesting for a doctor of biology. You have to know that it is a job where this type of profile is favorized. The profiles of doctor of biology or post-doc. This is the job of MSL. So it’s Medical Scientific Liaison. So, these are professionals who are in charge of being in contact with medical doctors. But for all the scientific aspects of the products, if the medical doctors have questions about the products, if the doctors want to carry out projects such as clinical studies as a sponsor, then they are in contact with these MSLs and the MSLs help them to set up their clinical studies. So, it is not a job of clinical research, but it is a job that is very close to clinical research.

So, there are these three professions that I think are more adapted and according to what the doctor of biology appreciates. If he appreciates doing control and working on something very administrative, he will choose the CRA profession or the project leader profession. If he has a preference for writing, for the scientific aspect in the sense of document writing, writing articles, research, etc., bibliographical, then he will be more of a medical writer. If he has a penchant for relating to medical doctors, reporting scientific information, setting up projects with them, then he will be earlier on the MSL professions.

So, thank you for following me and I’ll see you very soon.

The earthquake: Invalidating the Privacy Shield and clinical research (Now, what?)

If you need a service of a lawyer in France for better understand the french law contact us www.pharmaspecific.com

Transcription : Hello everyone, this is Manon Durand, health lawyer with Pharmaspecific. Today, we are going to talk about the protection of personal data through the invalidation of the privacy shield. Since you couldn’t miss this information, the privacy shield has recently been invalidated by the Court of Justice of the European Union. Before starting, I would like to remind you that you can find all our legal information on our Pharmaspecific training website to keep you informed of the latest news in the field of clinical research. If you have a question of legal order, you can also ask me about it on the same platform to get an answer. So let’s start right away on the topic of the day.

As a reminder, the privacy shield was agreed in the field of personal data protection law negotiated between 2015 and 2016 between the European Union on the one hand, and the United States of America on the other hand. The privacy shield consisted of a series of provisions that regulated the protection of personal data that was transferred from a member state of the union to the United States, which in fact made it possible to transfer data without having to resort to the various protection mechanisms that are provided for today by the GDPR. In particular, the standard contractual clauses, binding corporates rooms etc…

The privacy shield had itself been put in place following the invalidation of the safe harbor by the European Court of Justice, which in October 2015 issued a first decision in which it considered that the safe harbor did not provide an adequate level of protection. Following this decision, the privacy shield was put in place to compensate for the failings of the safe harbor by adding additional guarantees for the individuals concerned. However, in a ruling handed down on July 16, 2020, the Court of Justice ruled that the privacy shield mechanism also did not make it possible to compensate for the limitations of U.S. law. According to the Court, the privacy shield system was not sufficiently independent from the US executive branch since US public authorities can access and use personal data transferred from the European Union. All this actually stems from the fact that the Cloud Act was passed in 2018, which is a law that in fact gives US companies full legitimacy to transfer their customers’ data independently of their hosting territory to any US judge who would request it without the owner or the country of residence or the country storing the data being informed. The Court of Justice considers that such access and use by the U.S. authorities therefore does not meet requirements equivalent to those expected under European Union law by what is known as the principle of proportionality, since surveillance programs based on U.S. regulations are not limited to what is strictly necessary. Therefore, since the privacy shield system does not ensure an adequate level of protection, the adequacy decision rendered in 2016 was then overturned by the Court of Justice and the transfers of personal data can therefore no longer be made freely to organizations located on US soil, even if they are members of the privacy shield.

So, if you need to transfer personal data to a company located on U.S. soil, you must have sufficient guarantees, particularly with the help of the various tools put in place by the RGPD. As a clinical project manager, several verifications must therefore be made. First, it is necessary for you to make an assessment of the personal data that may fall under this scenario, particularly in cases where you use tools hosted in the United States. You must also be vigilant on this point because even large platforms like Microsoft are concerned by these new rules. You should therefore find out about the measures adopted by the hosters of all your work tools and check whether their personal data protection policies are adapted to the requirements of the RGPD and, if not, turn to European solutions. Then, if you are in connection with a clinical study whose sponsor is located in the United States, you must ensure that no transfer of data that will be collected in the European Union, such as patient data contained in the case report forms for example, is made to the United States without having put in place standard contractual clauses with this sponsor. These contractual clauses should be very precise on the measures adopted to guarantee the security of the transfer and I strongly recommend that you put in place an encryption solution for such transfers. You also have the site of the CNIL which proposes model contract clauses that can be used as a basis for setting up this tool. Finally, you should contact the DPO of your company in order to modify the different documents required by the CNIL. For example, processing records and impact analyses to bring them into line with the new measures you will have adopted.

That’s it, you are now informed of the reasons for the invalidation of the privacy shield and the consequences for your company and your clinical study. For any additional information, please do not hesitate to refer to our legal watch or to contact me to seek legal advice.

Thank you for listening to this podcast and feel free to share it with those who might be interested in this topic. As for us, we’ll see you soon for a new podcast.

If you need a CRA for your study in France, please contact www.pharmaspecific.com

Transcription : Hello everyone, this is Vanessa Montanari from the clinical research blog. Thank you for following us for so many years. It’s been almost 5 years that we’ve been doing articles and videos, also podcasts in clinical research.

So today, we are going to talk about the paper CRF, the electronic CRF, since someone asked me how can I present a paper CRF or an electronic CRF during an implementation?

So if you have a paper CRF. By the way, you have to be careful not to annoy the investigator too much. For that, the best is to try to present the paper CRF to him as quickly as possible, within approximately 1/4 hour. Because if he is the one who is going to fill it out, he will still have to fill it out correctly. You will thus initially present to him the various types of page; types of page compared to the various visits which there is in this CRF. You are going to introduce him to the important pages such as AE pages, concurrent treatment pages and SAE pages. So that he can see how to fill them in because if they are not filled in correctly, it will be quite embarrassing for you and you will have to ask him for corrections regularly. So, you will explain to him how to fill in those pages properly. What are the rules for filling in the CRF. So, there are some basic rules for filling in a CRF. They will be in the CRF filling guides. So, this is what you should use so that you can actually prepare this explanation for the investigator.

Then, you also tell him/her about the pages that are unusual. Often your investigator is already an investigator, not a new investigator. So, he is used to filling out CRFs and you will have to put your fingers on things that are not usual for filling out a CRF. For example, procedure pages, treatment pages. For example, these are pages that are not always present. So, you will have to tell him about those pages if you have them.

Then, if you have an electronic CRF, then it’s a little bit easier. In fact, if your electronic CRF is an CRF that is already widely used in clinical research, you won’t have a lot of work to do because you’re just going to ask, obviously well before the implementation, if the investigator is already trained in that electronic CRF if his SC is already trained in that electronic CRF and then you’re going to get his training certificates back. It has to be recent. It depends on your CRO or your pharma laboratory. So there is a time limit often 1-2 years. They have to be trained 1-2 years before they can use the CRF. Then it depends on the version of the CRF because versions change so they have to be trained on the latest version. In this case, you will just have to present during the implementation, if they have been trained, only which CRF is being used and how often it needs to be completed for example. But you won’t have to do much. But if they haven’t been trained, they will have to do the online training. So you’re either going to ask them to do it up front so that on the day of implementation they’re ready for inclusion. Then, often, the electronic CRFs are linked to randomization platforms. So in that case, you would have to explain to them how randomization is done in relation to the CRF. That is, what role the CRF has in relation to randomization, because sometimes the CRF as the platform for randomization is very connected.

So I hope this podcast has helped you and I wish you a good implementation tour and see you soon.

Feel free to share this podcast so that others can benefit from these tips.

Goodbye.