Filing signed informed consent forms in site file

[plamb]

I'm working at investigator site and normally we have "Patient Information Sheet and Consent Form" in one set e.g. patient information sheet starting from page 1 to 14 and then on page 15 is Consent form. Version control is implemented. Is it fine to file only "signed informed consent form" (page 15th) in site file?

[a123456]

Interesting question. May auditors and inspectors feel that the full consent form (that is all information given to the subject during the consent interview) which forms part of the consent document, should be retained in full by both the investigator and subject. The reasons for this are various. ICH GCP E6 4.8.11 states that:- "Prior to participation in the trial, the subject or the subject's legally acceptable representative should receive a copy of the signed and dated written informed consent form and any other written information provided to the subjects". Also ICH GCP E6 8.3.12 states that the investigator must file the "signed informed consent forms ,to document that consent is obtained in accordance with GCP". From this we can conclude that the investigator needs to be able to show what an individual subject consented to and what was the basis for their decision to participate. There have been Inspection findings in the past, based upon the fact that consent forms have been changed and/or annotated, without the IRB/IEC approving such changes. The presence of the full consent form, intact, gives some assurance that no such changes were made to the consent information that was signed by the subject. Also hopefully the retention of all pages will also give some assurance that the full and correct (approved) version of the consent form was used with this subject.

[MHRA Moderator]

MHRA Moderator comment:
There are benefits to keeping a complete copy of the patient information sheet and consent form (as provided to the subject), for example, this allows for reconstruction of what information was provided to the subject at the time of consent and also gives future researchers/other investigator site staff useful information on what trials the subject has participated in or is currently involved in. If a decision is taken to not include a complete copy of the patient information sheet and consent form, then the trial records should make clear where a complete copy of this form can be obtained, for example, details of where the master copy is located in the site files.

[David Montgomery]

ICH guideline E6 (GCP) does provide a lot of clues. However, you should also be mindful of that important phrase it includes

applicable regulatory requirements

. Consequently, you will need to comply with the policies on record-keeping within the NHS and more specifically within your own Trust. Indeed, having policies or better still, SOPs in place across a Trust (or organisation) ensures consistency in the management of documents related to clinical research irrespective of which department or unit they are conducted in.

The MHRA Moderator has highlighted that

trial records should make clear where a complete copy

of the informed consent can be found. Better still, , there is no mention that this should be achieved using the overused and oft perceived panacea for all ills: the FILE NOTE.

In addition to the signed consent forms, doctors are required to record the main parts of the consent discussion (for clinical trials involving IMP's) -- this is reinforced in the GMC guidance document:

http://www.gmc-uk.org/static/documen...ance_FINAL.pdf

The MHRA Moderator's comment: The reference to Trust's policy is valid but Trusts' policies are not regulatory requirements.

[ztarfizh]

It is valid to make a distinction here between documents filed in the site TMF (aka investigator study file) and those filed in the patient's medical record. In the latter, it is appropriate to file the full document set, in order that other clinicians can see what the study involved and what the patient consented to.

In the case of the site TMF, in my view it should be sufficient to file a master copy of the information sheet and consent form, and then the individual signed sconsent forms, provided that there is a clear reference on the consent form regarding which version of the document was provided. This can be achieved either by having the information sheet and consent form as a combined document, as you describe, such that the consent form is page 15, with a version number and date which coincides with that on the information sheet. Alternatively, if a separate document, the consent form should include a statement which makes specific reference to the version number and date of the information sheet.

[G&T]

Happy New Year MHRA Forum.
Expanding on this thread - As a host/participating site, in a multi-centre trial, in the absence of guidance provided by the sponsor and/or local procedure, where should the original signed informed consent be filed (study folder/patients medical record?). Thank you.