Hand-written notes in ICF/ verbal consent documented in ICF

[C.Santos]

Good day,
I would like to have your opinion on a recent case, where the site PI believes there is no compliance issue in the way he handled the consent process. A non-significant protocol amendment was not timely included in the ICF. The change required 10 times creatinine tests instead of 8 without increased burden for the patient (same number of blood draws and same amount of blood). The PI believed it was beneficial for the patient to have the 2 additional measurement and verbally informed the patient who agreed to it. He documented per hand-writing in ICF and medical files.

We documented a deviation and informed PI, and asked him to inform EC as well.
I read in a training for investigators from a medical society that PIs are allowed to make hand-written notes in ICF (but mandatory to add that to source document). I discourage sites to do that as it might not be legible, clear and understandable, and the color can fade with time. Additionally, site should have a process for verbal consents (to be used on those categories where it is allowed).

Thanks in advance for any thoughts on that!
Kind regards,
C.S.

[a123456]

Difficult to advise without knowing all the facts.

I assume that the IRB/IEC approved ICF does state how many tests are performed as well as how many blood draws are done.

Clinical trials operate to GCP and are unlike normal clinical practise where a doctor may be able to annotate things.

Unless the PI has to take Urgent Safety Measures to protect the participant for immediate hazard to health, then they must comply with all aspects of the approved protocol and ICF and not add or detract from them.

You should also follow your escalation process to judge whether this is a Serious Breach. I don't think it is an SB , but you need to document your usual process.

[a123456]

I don't understand.

The only way that the number of tests can be changed would be via a formal protocol amendment that is approved by IRB/IEC. The protocol amendment would include any changes to ICF as necessary. No changes can be made until after approval, unless they are part of an Urgent Safety Measure to prevent immediate hazard to health (in which case the Sponsor, IEC and RA are immediately informed).

A copy of ICH E6 is very useful here. section 3.3.7 and 4.5.2 lists what it thinks of an administrative changes to the protocol as being "e.. change of monitors, change of telephone numbers."

Compliance is very important.