Localisation of signed Informed Consent - Where exactly do I have to store a signed informed consent and why?

The following question was asked on Linked in, GCP group:

Localisation of signed Informed Consent - Where exactly do I have to store a signed informed consent and why? As I am in a discussion with a monitor I would like to ask you.
Please understand I think I do know my GCP, and think I have a normal/good common sense ;-). As we, the monitor and I, differ in this discussion about the exact localisation (as in detail - which dossier/file) and why, I am curious as what you will have to say, without telling you what/how I think about it. So you will have an open mind about it. I am working on site/hospital in hemato-oncology as a CCRC. Thank you so much for your attention.

The question was commented as follows:

Linda James • ICHGCP E6, 8.2.3 references that the blank models to be filed in ISF and Sponsor File.
8.3.12 reference states that signed forms should only be filed in the ISF. The protects data privacy of the patient too.

Jim Sheets • ICH says they should be "located in the files of the investigator/institution." It doesn't matter if they're all kept together in one reguatory binder at the site, separately in each patients' case history, or with individual patient case report form binders. As long as the access is limited and controlled, you are free to choose the system that works best for your site.

Lynda Cedar • The following procedure works for both, Investigator and sponsor sites. It is just one of the ways of handling study components.
Regarding the ICF part, the objective of the way is to prevent the confidentiality during the process and also in knowing where to find them (as put in the same place), it makes them easily accessible at any time as needed.

- At the pre-study period: at this step, the study has just started, it is new to the staff, it's important that all documents of recruitment stay at one place, with two persons (in case, one is absent). In having them at one place, it prevents to loose any important document at this step.
The confidentiality of subjects is protected better as only the staff involved with the recruitment of this study would access the subjects’ chart.
Either with EDC or manual recruitment, the status of the subjects enrolled can be known at a glance at any time
The ICFs are inserted in the subjects' chart.

- At the on-study period: when the ICFs have been signed, checked and considered final, the QA signs the form of transferring them/it into the reg. binder(s). This make the ICFs safe, and if needed (for any reason), they are easily accessible all the time.

- At the post-study: when all the study binders are considered complete, checked and final (after the study close-out), they are transferred to the archives.

@Dominique: I occupied similar position at the antitumor center, Institute Jules Bordet (Brussels, Belgium), for the patients of our hospital included in the clinical studies; I managed the files as explained above (little adjustment). That has been few years ago but if you want I can provide you with more details (privately).

Shirley Isbill • Re: - At the post-study: when all the study binders are considered complete, checked and final (after the study close-out), they are transferred to the archives.

Sometimes it is difficult to retrieve the ICFs and other records from an archive, especially a hospital record archive. The ICFs and other records need to be available to regulatory auditors.

Lynda Cedar • Yes, that is true. However, as the sponsor is responsible of archiving the study components, the originals are kept with him. If the study conduct was delegated to a CRO, a copy is also archived by the CRO (internally or externally).

As for the hospitals, as a monitor, I provide them with the visits at the study start and I recall and confirm the visit a long time before I show up; and most of the time I don't find the charts when I arrive...... Therefore, it would be better to make the info available to the auditors by the sponsor or the CRO and let them to decide whether they go to the hospital or not.

Dominique S. • Thank you all for your answers! I was so curious about the reactions. Thank you.

On our site the process is as follows (on study i.e. active recruiting enrolment period)
1. To file the original and signed informed consent in the patient medical file. It took me a while to ensure and convince some of the PI/SI to be very careful with a signed IC – now they all do it correctly! I don’t feel to change this embedded procedure. And this way medical personnel will know about the IC as well.
2. In ISF there is a ‘Note to File’ where to find the signed IC and the Inclusion and Enrolment Log Form. Inclusion Log also reveals date of IC.
3. If a monitor needs to view a medical file the only one who will provide him with one is my college or myself.
4. All monitors will have to sign a confidentiallity agreement about patient files and patient digital data on site.

This monitor states – “I cannot open a medical file if I have not seen a signed IC. If an IC is in the patient dossier I cannot verify it.” He wants to have IC in the ISF. I am totally content if he makes a copy and files it in the ISF. He does not want to do the copying.

As Linda and Jim refer to GCP chapter 8, I totally agree – the handy list. And indeed it only states “located in the files of the investigator/institution.” it does not mention the name of the binder or file. And the funny thing is that I just had a re-read of 8.3.13 which states [… To include original documents related to the trial, …] again “located in the files of the investigator/institution” – is this my final answer ;-)?

Thank you Shirley for the archive tip. Though sometimes a patient file is still easier to find than boxes with trial archives of trials conducted by retired physicians and no body knows…

And in my case a sponsor will probably never be in charge of archiving trial components of our site (as trial is closed). And as IC shows the true name of the patient, and not an anonymous trial number – I think this cannot be in the sponsor archives.

Thank you again for your reaction!

Shirley Isbill • If you intend to comply with ICH, sections 8.3.12 and 8.3.13 require that the source documents and signed ICF documents be filed in the investigator’s files, not the sponsor’s files (see essential document filing locations). Generally, the sponsor has no need to know the identity of the subjects which would be included in the ICFs (originals or copies). Additionally, 21 CFR 312.62 requires the Investigator (not the study sponsor) retain the drug study records including the ICFs. There is no provision within 21 CFR 312 for the transfer of storage of the study records from the Investigator to the sponsor; 21 CFR 812.140 does provide for this transfer, but for device studies only. As an FDA auditor I would cite an Investigator if he did not have the original drug study records and they were not available for review at the time of my audit. Having the sponsor supply Investigator records to an FDA auditor is not required or recommended anywhere, it impedes the FDA audit of the Investigator’s records and provides an opportunity for the sponsor to limit record access. The original ICFs should be filed in the Investigator’s study records.

Shirley Isbill • Re: This monitor states – “I cannot open a medical file if I have not seen a signed IC. If an IC is in the patient dossier I cannot verify it.” He wants to have IC in the ISF. I am totally content if he makes a copy and files it in the ISF. He does not want to do the copying.

You need to refer this matter to the sponsor; the monitor is creating an unnecessary problem and is lazy.

Dominique S. • Thank you Shirley. Indeed all our documents are filed on site with proper labeling. And yes all site required documents will be stored/archived on site according to GCP Chapter 8. In another comment it was mentioned as archiving could be done at sponsor, not in my case/on my site.

And thank you for the smile I had a about the lazy monitor ;-)

Lynda Cedar • @Dominique: I just want to clarify that at the time of archiving the study components by the sponsor, the ICFs are put in envelops that are closed with a legal stamp (red circle), and a note is printed on the envelops (can be opened by an authorized person only and in following SOP_____). The Sponsors and CROs have SOPs: how to disclose the subject ID all the time when needed, or how to disclose the randomization code when needed,......etc.....
On the other hand, the sponsor is responsible for archiving the study for 25 years Iin Canada), he has the rights to ask for the originals and copies are kept by the site (hospital) and the CRO, for their own interests.

When a study has been finished, completed, closed and archived, why a sponsor would access it if not needed? if so, the log-book of the archives is signed by the person who needs to access the study files, and the following information is collected: Date(s), time (in and out), title and position, and the reason.
The study files cannot be taken out of the archives, unless for a big big reason (as an inspection for few days) and it requests the sponsor permission.

Dominique S. • Thank yo Lynda for your explanation. I am not familiar with archiving at sponsor. In the Netherlands its 15 years - both sponsor and investigator are responsible as in chapter 8.

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Jim Sheets • Informed consents containing signatures should remain at the investigator's facility.

Lynda Cedar • The investigator keep a copy for his own concern, as the patients were enrolled and treated by him, they are his patients….. they per say ‘‘belong” to him (sorry for the English), I’m not sure, but I think (regarding the ICFs) he can decide to keep the originals and provide the sponsor with a copy.

The ICFs can remain with the investigator and kept with the medical chart, reg. binder or as by the site's procedure, however, the sponsor has the rights to decide to archive all the study components including the ICFs, mainly for some kind of medication (new medication that is not well known or the case of some biosimilars),

The sponsor is the first concerned by any happening with the medication, for many years after a study has been closed-out. In Canada, since 2001, the archiving period is for 25 years. In my experience, when sponsors wanted to keep the ICFs as well as the other components of the study, the attorney advised to put such document (ICF) in an envelop that is sealed legally , and a warning note written on it, plus a SOP of handling it. The regulatory authorities were consulted and were comfortable with this way of ensuring the confidentiality of the ICFs during their archiving for 25 years.
Sponsors are advised to archive the study components at 2 different places, to ensure that at least one copy stays safe.

Martin Robinson • As long as the signed copy is readily available (for audit, inspection or monitoring)at the investigator site it doesn't matter where you keep it as long as it is safe. Some investigators keep them all together in the investigator site file, others keep the forms with the patient notes
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Glenda Guest • And among all this debate, it is proper for the monitor to verify informed consent prior to looking into a subject's confidential records. Where that document is filed and how it is accesed are certainly flexible as this discussion has shown.