Bioequivalence and Bioavailability Forum

Dear Joshi,

Don't do that if you have an inspection. Inspectors will most likely consider it as an obstruction and they will consider that you have not demonstrated that the subjects' informed consent has been obtained. Which may result in the rejection of your trial.

Remember section 4.8.10 of the ICH GCP guideline: Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of the following: [...] n) That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct access to the subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject or the subject's legally acceptable representative is authorizing such access.

"Without violating the confidentiality of the subject" is not interpreted as meaning that they should not have access to the subject's name, but rather as access only to information relevant for the trial.

But IMHO giving direct on-site access, under control from your staff, would be quite different from sending out documents.

Regards
Ohlbe

Dear Vishal,

I'm afraid I can't agree with you.

❝ ... by the name nobody can identify the subject...

No ? As far as I know there is nobody in France with the same first name, family name and age as myself.

Please refer to the ICH GCP guideline, §2.11: The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s). Also refer to the Declaration of Helsinki, §21: Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patient's information [...].

The CRF is anonymised. Source documents such as lab reports or ECGs can be identified with the subject number and initials. And why would you send copies of the ICF to the sponsor or regulatory authorities ?

If for any reason you need to send ICF copies, and unless there are specific regulatory requirements or recommendations* in your country, I would suggest to keep on the ICFs only the initials of the subjects (or the first 3 letters of the name + the first 2 letters of the first name) and mask the rest. Same for the signature if it is readable. Which would make it totally useless to transmit copies of ICFs anyway .

* For clinical trials conducted in France we do have a specific official recommendation. As conducting trials without the subject's consent is liable to prosecution, and as the sponsor could be prosecuted too, it is recommended that the sponsor take non-anonymised copies of the ICFs, put in sealed envelopes by the investigator. The investigator should sign the envelope. If should not be possible to open and re-seal the envelope. Envelopes can only be opened by the French regulatory authority or justice, in case the original ICF gets lost by the investigator. This is just a recommendation, not in our regulations. And I would not recommend to extrapolate it to other countries, unless it is done officially by that country's authorities.

Regards
Ohlbe

Dear Vishal,

I agree with Ohlbe.

To quote the Germany's Medicines Law, Section 40(2a):
(2a) The person concerned shall be informed of the purpose and scope of the recording and use of personal data, especially medical data. The person concerned shall be informed especially of the fact that:
1. where necessary, the recorded data:
a) will be kept available for inspection by the supervisory authority or the sponsor's representative in order to verify the proper conduct of the clinical trial,
b) will be passed on in a pseudonymised version to the sponsor or to an agency commissioned by the latter for the purpose of scientific evaluation,
c) will be passed on, in pseudonymised version, to the applicant and the competent authority for the marketing authorisation if an application for a marketing authorisation is filed,
d) will be passed on, in pseudonymised version, to the sponsor and the competent authority and subsequently by the latter to the European database in the event of undesirable events in connection with the investigational medicinal product, [...]

Regards,
Hermann