How should a mistake be corrected in the ICF?

The question was asked on Linked in as follows

Imagine the following situation: a participant is recruited on 11OCT2010 but in the ICFhe/she wrote by mistake 11NOV2010. During a Monitoring Visit in December 2010 the issue is detected by the CRA. How should it be corrected? I propose 3 ways, please I kindly ask you to comment them (more options are welcome!):
1) the participant cancel the wrong date (11NOV2011), write the correct date (11OCT2011) and date and sign the correction using the date he/she corrected the ICF (let's say on January 2011). At the following monitoring visit the monitor verifies that the correction is done.
2) the same that option 1 but the participant writes in the ICF that he/she consented during the recruitment process, before any intervention was done.
3) the same that option 2 but not writing in the ICF but using a Note To File and attaching it to the ICF Just for your information: it’s a phase IV Clinical Trial conducted in rural areas in Africa. 5,000 participants recruited in 4 sites in 18 months.

Fiona Waddell• All 3 should be done. The patient makes the correction, the investigator confirms that the trial did not start for this patient prior to signing the ICF and the investigator explains what happened and how it was corrected in a File Note. You also need to look at how this happened to ensure it doesn't happen again. The monitor should verify the study site ICF process to ensure that there is a validation step included (ICF document has been completed correctly). There may be a need for additional training in this process.

Kristaps Danilans From my opinion File Note will not helps you much. As I understood only subject dated Nov, not both (subject and investigator)? If you notice different dates or months, I would suggest to add statement in the ICF explaining when actually subject agreed to participate and how this mistake happen. The statement again should be signed by investigator and subject. Also more information should be available in subject source documents.

Catherine POUZET • From my opinion a file not is not the solution: the key in clinical trial is tracability of the information : you have to document the correct date of participation of the subject : i suggest to ask your CQA representative to see what process to follow : be sure that if ICF is corrected that it will be for the one on the investigator site and the form for the patient; Source document and also monitoring report should be completed with an explanation of the correction; The PI should be retrained on ICF process : this should be noticed in a training log.

Jumoke Arogundade • What had happened at one of my sites, was getting the patient to sign a new consent form on the next visit, counter-signed by the investigator and a File note filed with both the new and the old consent explaining what had happended and how it was corrected. In the source notes of the patient's visit when the new consent his signed the doctor once again confirms in his case notes what had happened previously and the need to sign a new consent. This is evident for the CRA to monitor and an auditor/inspector to see

Saranya Kannaian • I think all the three steps should be followed.An explanation in the form of a file note is fine to be archived with the study file after the study is completed.More important is the signature of the participant (and when signed the document)as well as the sign and date by the investigator and also important is to make a note of why the change was made in the ICF itself, so that the information is visible immediately rather than searching for the file note, if the cause has to be explained later.

Saranya Kannaian • I agree with Fiona that there must be an additional training on this process.

Ludmila Sklyar • I agree with Fiona too, re to NtF , in some place CRA and PI should explain /document what happen to be sure that any study related procedures have not been done before ICF signature.

Anuradha Venkatraman• I agree with Ludmila that no study procedures have to be performed prior to ICF signature. Considering the situation stated by Daniel, where informed consent form (ICF) was post dated and suppose study related procedures were done on the subject/patient prior to the dated ICF. -ICF to be re-signed and dated by the patient and PI; -NTF detailing the reason for the error to be filed; and -I believe the same has to be notified to IRB/IEC as the safety of patient comes into picture in this scenario. -Apart from this, site has to be re-trained to avoid such errors as it could be a protocol violation if the study procedures are done prior to dated ICF. Kindly opine if I am wrong.

Lynda Cedar, Ph.D. • Hello Daniel. You are saying In 2) the same that option 1 but the participant writes in the ICF that he/she consented during the recruitment process, before any intervention was done. If no intervention was done, therefore, no mistake happened. In preventing drop-outs, some CRO ask the subjects to sign the ICF when they are very close to the first intervention undertaking. Exemple, if the subject gets sick while he received the information, but not enrolled yet, by signing an ICF, s/he is discounted , there is no AE record as no ICF has been signed. If you choose the option of correcting the date of the original ICF, you can do that too, cross, initial and date the change, in front of a witness. A note to file is always a good to have; if a key person who knows about the event forgets about it or change the job, the record is on file. This is typically true for studies of long life as Phase III, IV.