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Here are 5 points to remember when you’re CRA, CSC or project manager. Certain prejudices die hard and sometimes we do things that are not required by French law … we do this because “it is requested by the Sponsor”, other times, we learned some things and we have simply…forgotten.

1. Persons participating in a clinical research must be informed of the results in the final report.

The last paragraph of Article L. 1122-1 of the CSP provides that at the outcome of the research, the person who has consented to it has the right to be informed about the overall results of this research, in the manner that will be clarified to him in the information document. The effective date of the end of the research is “the term of the participation of the last person consenting to research or, where applicable, the term defined in the Protocol” (Article R. 1123-59 of the CSP). It is also expected that within a period of one year following the end of the research, a final report is prepared by the promoter and that the investigators are informed of the results of research by the coordinating investigator or promoter (Article R. CSP 1123-1160) (see also question 9.1 of this document). Thus, people can be informed of the results of research by the investigator after the final report (FAQ ANSM).

As a member of the promoter, when working on a study, the investigators are informed of the final report. However, they sometimes forget that patients should be informed of the results of the study. Promoters or foreign project managers do not always pay attention to this point. It is to us, French CRA to report it and remind that it should be done as required by law. Patient associations plunge, by the way, on the issue. A patient cannot receive a study report that is far too complex … It is the investigator who will inform him. The question is: “How to provide information in a relevant way to the patient?”

2. The investigator has no obligation to countersign biological balance sheets to prove his acknowledgement.

No, it is not required in the GCP (decision of 24 November 2006 establishing the rules of good clinical practice for biomedical research involving human medicines) that the investigator countersigns the report of analysis which is a source document.

The acknowledgment by the investigator of these reports of analysis should be documented and may, for example, be mentioned in the medical record of the person consenting to research, thus avoiding any ambiguity on signing a document issued by another specialist, biologist for example. This acknowledgment by the investigator enables him to identify the abnormal analysis results identified in the protocol as critical to the assessment of the safety of persons consenting to biomedical research as appropriate to meet the notification requirements to the promoter (L.1123-10 articles and R.1123-54 CSP and point 4.11of GCP). The investigator must ensure that the data from these reports are available and, if applicable, recorded in case report forms gradually, accurately, completely and legibly and are consistent with the documents sources from which they originate. (FAQ ANSM)

This view of the ANSM is rather interesting. I understand that here, as long as the investigator documents the acknowledgement of reports in the medical record, he does not need to sign the reports. Only problem, it is not always documented in the medical records by investigators … For now, I keep asking they countersign the biological balance sheets. This seems simpler to me than ask them to change the way they write their report.

3. The patient’s medical record must clearly specify the conditions for signing the informed consent.

The record of the person who consents to research corresponds to the medical file with all documents bringing together the personal and medical information about the person (e.g. hospital record, observation sheet…). This information is related to the health of a person who may be sick or does not show any affection.

For users of the health system, the information to be contained in the medical records is in the first paragraph of Article L. 1111-7 and Articles R. 1112-2 and R. 1112-3 of the CSP.

As part of the research, this file is used to verify the authenticity and consistency of information collected in the report form and if necessary to complete or correct these specifications, provided that the conditions regulating the use and consultation of these documents are observed.

The participation of the person to the research and the terms of obtaining his consent and providing information to gather it are specified in this file. (FAQ ANSM)

It is clear here that the method of obtaining consent must be documented in the medical record. The modality is how the doctor obtained informed consent. A simple phrase: “Consent signed today” to document obtaining consent is not sufficient. However, there is no sentence-type.

Many promoters offer to pick up the following ideas:

• The patient was able to ask all the required questions,
• The signature of consent occurred before any procedure of the study,
• A copy was given to the patient.

In my opinion, this is a good idea 🙂 

4. The promoter of a clinical trial must begin to collect and assess adverse events for a given patient from the signature of the consent and not from the date of taking the study drug.

The regulation of biomedical research requires the collection and evaluation of adverse events occurring during the research including in particular those related to the product and those related to the clinical trial procedures. The collection by the investigator and promoter of events and adverse events mentioned in Article L. 1123-10 of the CSP is made from the actual date of commencement of the research corresponding to the date of consent signature by the first person consenting to research. For a given participant, this collection starts from the date of signing the consent form.

An adverse event is defined as any untoward medical incidence that occurs in a person consenting to biomedical research that this event is related or not to research or product to which this research relates (Article R. 1123-39, 1). An adverse effect of an experimental drug is defined as any untoward and unintended responses to an experimental drug regardless of the administered dose (Article R. 1123-39, 3) ( FAQ ANSM)

Sometimes some promoter recovers AEs from taking treatment… A priori, the ANSM does not agree with this… No comment, I agree with the ANSM

5. The batch certificate and analysis certificate are to be provided to the pharmacist when you transmit the experimental drugs.

When biomedical research involving a drug is taken to a health facility with internal use pharmacy (IUP), the promoter shall notify beforehand the pharmacist responsible for the management, for information (Article R.1123-64 CSP and point 5.12.3 of the decision on 24 November 2006 of the Director General of the Afssaps became ANSM on GCP for biomedical research involving human medicines):

– The title and objective of the research;

– The following information about the experimental drug:

o the pharmaceutical form, or lot numbers and expiry date of the experimental product;

o for the experienced drug or used as a reference, its special or scientific name or code name, its qualitative and quantitative composition in active substances and constituents of the excipient, knowledge of which is essential for proper administration of the drug, using International Nonproprietary Names, where they exist, or failing that, the names of the European or French Pharmacopoeia;

o for a placebo, its composition;

– The investigator’s brochure mentioned in Article R. 1123-20 of the CSP;

– the elements of the protocol of useful research for the possession and dispensing of medicines and used drugs;

– The identity of the investigators and the location(s) involved in the establishment;

– The date on which it is planned to start the research and its anticipated duration.
The pharmacist also has the batch certificate signed by the qualified person and, if applicable, the analysis certificate of ME shipped (Point 8.2.16 of the decision on 24 November 2006 of the Director General of the Afssaps became ANSM related to GCPs for biomedical research involving human medicines). The batch certificate meets the harmonized model presented in Appendix 3 of the particular guideline 13 of BPF (decision on 13 January 2011 of the Director General of the Afssaps became ANSM related to BPF). (FAQ ANSM)

Sometimes promoter sends some treatments without providing the batch certificate and the analysis certificate. As CRAs, we will ensure that the investigator’s workbook is up to date. It is for us also to check if the documents are sent and stored in the Investigator’s workbook (or the pharmacist). So I let you check this point fast J

And you what do you think of ANSM answers? Tell us everything in the comments.

You’ll find all this information and many others very interesting in the FAQ (Frequently Asked Questions) of ANSM. Good reading!

Sources: FAQ ANSM (2012)