Welcome to our “Q & A with QA” posting created by the Quality Assurance team. We believe all questions are important and if one individual has a question about something, then it’s likely others may as well. Our intention for this blog post is to provide information on common themed questions we are asked so that everyone can be included in the conversation. Of note, the questions we post are paraphrased and not taken directly from any one individual.
Our participant was emailed an ICF to review prior to the remote consent discussion. The consent discussion took place and the participant signed the consent and mailed it back to us, however, some of the pages are not legible due to a printer malfunction. What is the right way to address this situation?
We recommend the POC document what has happened in detail in the consent documentation encounter. If participant responses were affected (e.g., check-boxes, signature pages) then reconsenting the participant would be appropriate.
We also recommend the documentation to include:
1. That the participant had received all pages of the ICF which were reviewed remotely with the person obtaining consent.
2. That instructions were given regarding printing, signing and sending back.
3. What exactly was received upon review of the participant signed ICF.
4. That the study team has informed the participant of the error and that the illegible pages (if other than the signature pages or checkbox option pages) will be replaced in the fully executed copy being sent to them. If reconsenting is necessary (i.e., participant responses are illegible), inform the participant of this as well, the reasons why, and arrange a meeting to reconsent them, once they’ve confirmed their printer is working (if being performed remotely again).
5. And finally, that the participant was sent (or handed, if performed in person) a legible copy of the fully executed ICF. In addition, we do recommend keeping the illegible pages received for study records.
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