Stanford Cancer Institute Clinical Trials Office Blog

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.

---

Question:

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?  

Answer:

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.

---

Want to keep the conversation going?

Please join us at our Wednesday 9:00-9:30 QA Virtual Chat Join from PC, Mac, Linux, iOS or Android:

 https://stanford.zoom.us/j/93986583586?pwd=WmsrOUc2VklFbGN4amp5amxGUDZwUT09

Password: 153280

Or please feel free to send your questions to: dsmc-quality@stanford.edu

“Q & A with QA”Welcome to our first posting of “Q & A with QA” 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 have as well, or will at some point. We hope these blog posts will provide insight into common questions asked by study teams so that everyone can be included in the conversations. Of note, the questions we post are paraphrased and not taken directly from any one individual.

---

Question:

What is the best way to document that the treating investigator has reviewed and assessed safety labs (as clinically significant (CS) or not clinically significant (NCS))?  We currently print the lab results for signing/dating by the treating investigator to document their assessment, but we would like to move away from paper.  What are our options?

Answer:

Printing the lab results and having the investigator document their assessment if CS or not is certainly one reliable method.  

• An alternative method to document the review of safety labs by the treating provider is via the electronic medical record. The lab results can be pulled into the progress note for the applicable study visit, in which the treating investigator  can document that the labs were reviewed. If any out of range labs are present, the provider should indicate whether they are CS or NCS.  This allows real-time documentation as the e-signature verifies when the documentation occurred (meets ALCOA*).

For example, some teams have created a specific smart-phrase and utilized this in documentation encounters to indicate how they are documenting lab result assessment. The labs that need to be assessed are incorporated in the progress note, and the investigator bolds/highlights the specific labs that are assessed as clinically significant.  The smart-phrase will indicate “Clinically significant labs are bolded in red/highlighted”. 

Please discuss among your team to find a feasible work flow.

* Elements of Good Documentation Practice (GDP)= ALCOA

Attributable, Legible, Contemporaneous, Original, and Accurate.

---

Want to keep the conversation going?

Please join us at our Wednesday 9:00-9:30 QA Virtual Chat Join from PC, Mac, Linux, iOS or Android: https://stanford.zoom.us/j/93986583586?pwd=WmsrOUc2VklFbGN4amp5amxGUDZwUT09

Password: 153280

Or please feel free to send your questions to: dsmc-quality@stanford.edu