For ease and accuracy of serious adverse event (SAE) reporting for investigator-initiated trials (IITs), CTTO-Regulatory is introducing additional IIT SAE report forms. These forms are variants of the current form, but allow attribution to multiple agents within a single form. The two new PDFs forms below are available on the Coordinator Corner under the Forms tab in addition to the initial form of one agent:
Now posted on Coordinator Corner under the “Forms” tab and subtitle “Study Logs” are two editable PDF versions of the Delegation of Authority and Staff Personnel Training logs, both of which allow multiple signatures. Instructions are also listed with the two documents. Please review carefully.
To easily find the documents, click this link: https://med.stanford.edu/ccto/staff-resources/coordinator-corner.html#forms.
NOTE: Staff must open the document with the Adobe/Acrobat, an open option offered after you click on the website link. See example photo below.
If you have any questions, concerns, or experience problems, please reach out to Amanda Sullivan.
Our NCI Grant requires us to provide information on our patient population to illustrate that we are serving a broad population. Ethnicity and Race are such population characteristics therefore having the correct information in OnCore is required.
On Feb 13, 2020, OnCore started to receive multiple values for participant’s race. In the past, only the 1st captured information was passed from EPIC to OnCore. Now, for patient who is self-identified as a person of multi race, all of the race information are sent to OnCore from both SHC and LPCH. Please still ask the patient to verify his/her race and ethnicity using ‘NCI Ethnicity and Race Classification’ document located in the Forms section of the Coordinator Corner at the time of the consent. If the information is incorrect in OnCore, please correct it on the patient’s demographic page.
How do you know if Principal Investigator of a new study needs a PI waiver?
If the individual is not a member of the Academic Council (rank at Assistant, Associate or Full Professor) or MCL ( Medical Center Line) faculty, please go to the RMG website http://med.stanford.edu/rmg/grants/proposal-preparation—submission/pi-eligibility—waivers.html to review the PI eligibility and waiver process.
The REDCap intake survey has been a useful tool for coordinators to submit various requests to ccto-intake. The survey format enforces consistency in the submissions therefore improving the overall quality and efficiency of the intake process. However, the only way for coordinators to review a survey that has been already submitted (e.g., to confirm the attachments submitted, to confirm the information provided, etc…) is to use the link to the survey. There is already a button on the survey that sends the link to your email. However, since the email that you receive using this feature does not include much identifying information, sometimes it is very hard to go through your inbox to find the email with the correct link.
Example: The email notifications does not have any identifiers to know which protocol the link is for. So if you have submitted multiple requests, you would have to click and check each link.
How can we make this process easier and more efficient?
There are two very easy and quick ways to save the CCTO REDCap intake request surveys and all its contents!
1. Save the link to survey queue and save it somewhere together (e.g., Word/Excel document listing each submission link)
2. Bookmark the Survey Queue. You can create a bookmark folder on your internet browser and bookmark each submission. It has been helpful to bookmark it as soon as a request is created (not when completed) so that if you accidentally close your browser or you have to come back to the survey at a later time,
The second way is easier but there is one downside – if you do not have the bookmarks auto-synced or auto-backed up, there is a potential danger of losing all of your bookmarks if something goes wrong with the browser or your computer. Therefore, I highly suggest that you incorporate both ways into your workflow.
One more tip: If you accidentally close a survey without saving the link or bookmarking, you can retrieve the link from your browser’s recent history, as long as the survey was not created in incognito mode.
You may also reach out to firstname.lastname@example.org and request the link again if none of the above is an option. Please provide the following information:
- New study
- request ID
- PI name and protocol title
- PI name and sponsor
- OnCore number for SU IRB
- eProtocol number for external IRB
Also, some updates in the REDCap survey may happen soon that will make this process a lot easier!
Thank you to Jee Min Lee for sharing these instructions!