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Your first action, arriving on site, is to check out the informed consent forms. However, it is not always easy to know what to check and how to manage the nonconformities that you will have noted during the consent forms monitoring. Here is a short guide to help you review informed consent forms and patient information notes.

How to prepare consent forms monitoring?

This is it, your monitoring visit is booked, and this is your first trip on this site. Information notes to the patient and informed consent forms should be checked out. If you go to a site for the first time, even if one of your colleagues has already checked the consents in the past, think also to review the consents in order to make sure that you are really authorized to consult patient records, you never know.

It may be useful for you to check out the following information upstream to make sure you do not go wrong or forget information once on site:

• The number and nature of the consent forms and information notes that you should find on-site for each patient. In some studies, several consents may be provided for sub-studies, long-term sample preservation, different age groups, and different phases of the study or different situations (e.g. in case of inclusion in emergency situations). Not all patients need to sign all consents. Verify which consents must be signed by which patients.
• The date, the version of the consent forms and the information notes that you should find on-site for each patient. Have there been any amendments to the protocol? If so, verify what consent was in effect at the time of inclusion of each patient and which patients are affected by the changes.
• The information to be verified on the information note to the patient and the informed consent form. These documents may be different depending on the study promoter, the CRO or even the IRB who reviewed the document. To be sure not to spend too much time reviewing these documents and not forgetting information, verify what information you need to check out:
• Should the patient and the physician initial each page of the information note and the informed consent form?
• Is there information to be completed and on which pages (e.g. doctor’s name, contact details, etc.)? This information may be on the first page, in next-to-bottom, on the last page or anywhere in the consent)?
• Are there checkboxes to be checked by the patient? Your study may involve blood sampling or other optional tests. Note the page where these elements are located.

In order to be as efficient as possible once on-site, incorporate into your monitoring tool information on the verification of informed consents: date of inclusion of the patient, date of signature of the informed consents , version of the consents, name of the investigator who signed, information to be checked. You will use your tool to retrieve the essential information you will need to complete your report afterwards.

Also, consider printing the approved version of the informed consent forms and information note to the patient. In case of doubt on site, you will be able to easily access the documents to verify the information you are looking for.

What to do at the time of the consent forms on-site visit?

That’s it, you’re in front of the informed consent forms and the information notes to the patient, you just have to check them out. Consent is the first thing you monitor, you do not have the right to read patient medical records if you do not have written proof that the patient has agreed to participate in the study. If you do not have consent, you will not be able to monitor the patient’s file. Here is the information to check out on site:

1. As indicated above, type of consent, version and date of consent.
2. Number of pages: verify that all pages are present. Yes, all. That of the informed consent form and the information note to the patient.
3. Date of signing of informed consent. Make sure that the informed consent form was signed prior to the implementation of any procedure related to the study. The date of signature must be earlier or at least equal to the date of the first procedure specific to the study. Similarly, the date of signature of the investigator should be the same as that of the patient.
4. Signatory physician: ensure that the investigator who signed the informed consent form is clearly stated on the task delegation sheet and has been adequately trained in the study protocol.
5. Signatory Patient: ensure that the patient who signed is the patient whose you have the medical record and was included in the study (inclusion number of the patient, surname, first name, sometimes, date of birth).
6. Data to be completed/checked: verifies that the patient has checked the checkboxes he should check and that all the information has been completed by the patient and the center.

Once the informed consent form and information note have been monitored, it will be necessary to verify that the information is well documented in the patient’s source file. The promoter may have more or less important requirements, verify with the promoter his expectations. In general, the following information should be provided to verify that the center meets the Good Clinical Practice and the Law:

• The patient has received the information necessary for his participation in the study by the investigator,
• The patient was able to ask the questions he had and a response was given to all the patient’s questions,
• The patient had time to reflect on his participation,
• The patient agreed to participate and signed the informed consent form. Specify the signed version and the date of signature,
• The investigator signed the informed consent form,
• A copy of the signed consent form and information note was provided to the patient (or the duplicate in case of duplicate or triplicate forms)

In the case of a study of persons who are not in a position to give their informed consent or on minors: verify that the identity of the signatory and the documentation of the information and signature of the legal representative is in the file source. Attention, in France, both parents must sign the informed consent forms for minors. You will find the modalities of consent of persons particularly protected in article L1122-2 of the Code of Public Health.

Have you checked out everything and everything is compliant? Perfect, you can now open the patient’s medical record and begin to monitor.

Consent forms does not comply

Your consent may not be compliant. What to do? Here are some non-exhaustive examples of what might happen on-site.

First, try to understand what happened to prevent this from happening again in the future. Discuss with the CSC and the investigator and help them find a solution. In the case of non-compliance, systematically re-train investigators and CSCs in informed consent procedures to ensure that this does not happen again in the future.

Some non-conformities are not too serious and can be repaired immediately: if this has not been done, the signature of the consent can be documented in the source document a posteriori by the investigator. Be careful, however, to respect the ALCOA principles.

If the contact information for the center is missing from the information note or the informed consent form, make sure that this information has been given to the patient and asks the center to document it in the source file in accordance with the ALCOA principles.

Did you find two informed consent forms or information notes in the patient’s medical record? Make sure the center has given a copy to the patient. If this has not been the case, ask the center to give it to the patient as soon as possible and document it in the patient’s source folder.

Others, on the contrary, are more serious and require more attention: the doctor did not sign on the same date as the patient or the date of signature of the doctor or the patient is missing? Make sure the doctor has given the patient information in accordance with Good Clinical Practice. If the doctor simply forgot to date or sign at the patient’s arrival or the patient forgot to date, ask the investigator to document on the informed consent form and/or in the source documents that the information was given, the date on which the information was given and the reason why the doctor or patient did not sign the informed consent form on the same day, to date the amendment and initial it.

Similarly, if an undeclared investigator has signed the informed consent form, verify that the investigator was properly trained before signing the informed consent form and that he or she gave the correct information to the patient. Request the center to document the training date of the investigator on training certificates and to update the task delegation form.

If it appears that the signatory investigator was not declared or trained, that the patient did not have adequate information or no information at all or the patient did not sign an informed consent form, immediately convey the information to the project team. This is a major violation of good clinical practice and the promoter has to decide what actions to take next.

In the case of a non-compliant consent form and if the patient is expected to return to the site, the center should ask the patient to indicate what happened on the informed consent form, in writing, to date at the date of the day and to sign. For example, if there is a missing date, the patient must indicate that he/she has received the necessary information and has signed the informed consent form and specified the date on which the information was received.

Finally, it may be that by reviewing several informed consent forms, you realize that the handwriting of the investigator and the patients is similar or that several patients have the same handwriting, a similar signature, and so on. There may be suspicions of fraud. However, this is not a charge to be made lightly. Contact the project team to let them know the facts and follow their instructions.

Here are some helpful tips for verifying informed consent forms. Investigators may find the procedure of informed consent cumbersome, explain them why it is so important that all information is documented: in clinical research, which is not documented has not been done, so it is essential to note all stages of informed consent.

You want to go further on informed consents, here are some articles that should interest you:

Do you need to write an informed consent form?

USA: A new way to collect informed consent, the electronic way

You are CSC, here is how to assist the investigating physician on informed consents.

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