Stanford CCTO Prism Access for Research Monitors

Instructions:  Complete the online request form per User Guide for any monitor (i.e., Industry Sponsor, FDA) who requires Prism access for research auditing purposes.  For any questions, please contact ccto-prism@stanford.edu

Timeline:

  1. New Account Creation for Sponsor Monitors – It will take approximately 14 days from the submission of the request for new account. A requester can schedule a monitoring visit after the new account is created
  2. Record Release for Sponsor Monitors - A requester can request a release of records at a minimum of 14 days before the monitoring visit
  • If the requester does not receive a notification within 3 business days of the monitor’s first day of access, please email to ccto-prism@stanford.edu

You can request following services using the REDCap System.

  1.  New Account Creation for Prism Monitors
  2.  Record Release for Monitors
  3.  Visit Cancellation
  4.  Renewal of Previously Approved Monitor

IMPORTANT: Prior to completing form, ensure you have ALL the following information and documents available to upload:
 

  • Checklist for Required Documents for Sponsor Monitor Prism Account Creation:

Application approval process takes up to 14 days so the timing of the application to the planned monitoring should account for this timeframe.

  • ☑ Check if Monitor already has an approval in OnCore.
    • Login to OnCore, Go to Menu > Reports > Administrative > Prism Monitor Reports.  Search by Monitor Name, or Company ROI
    • If your monitor is on the list and has valid expiration date (for your monitor visit date) you do not have to request for new account creation. You can proceed with Record Release.
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  • ☑ Study Team provides the Request for Research Outside Monitor Remote “Read Only” Access to Study Records Through Stanford Health Care Prism Portal form (“Application Form”) to the monitor.
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  • ☑  Study team provides the Prism Remote Monitoring Video Training Session Video located in Stanford Box to the monitor.
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  • ☑  Study team provides the Monitor Handout Document (Download) to the monitor.
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  • ☑ When the monitor returns the signed application form, study team will verify that the document is complete:
    • ☑ Monitor completed all fields and signed page 3 of the Application Form.
      ☑ Monitor’s supervisor completed all relevant fields on page 3 and signed page 4 of the Application Form.
      ☑ Monitor printed their name of page 5 and signed/dated page 6 of the Confidentiality Statement.
      ☑ You have saved the complete application form in PDF format.
      ☑ Monitor has completed the remote monitoring video training session.
      ☑ Monitor has confirmed the location where the remote monitoring will take place.
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  • ☑ Navigate to the CCTO Monitor Request Form to access:
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  • Checklist for Record Release for Approved Monitor:

Application approval process takes up to 14 days so the timing of the application to the planned monitoring should account for this timeframe.

  • ☑ The ROI (requestor ID) of approved Monitor.
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  • ☑ Please check and make note of the expiration date of the monitor application using OnCore. Go to OnCore-Reports > Administrative > Prism Monitor Report. Type in ROI or Monitor Name to see the expiration date. The expiration date should be valid during the monitor visit date.
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  • ☑ Schedule Monitoring Visit DATE with CCTO-Admin via monitor_reservations@stanford.edu  The following will be required:
    • Monitor Name 
    • ROI Number
    • eProtocol Number
    • 3 preferred monitoring dates: (3 preferred dates)
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  • ☑ PDF of IRB Approval Letter (https://eprotocol.stanford.edu/). You can access IRB approval letter from OnCore under documents/info tab.  If there is a short form consent: include section 13 of IRB e-protocol and the IRB approval letter. If there are multiple short form consent, please make one combined PDF to upload in REDCap.
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  • ☑ Monitoring visit start date and end date – (Real scheduled date)
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  • ☑ List of Medical Record Number (MRNs) and subject name to which the monitor will need access. (LIMIT 8)
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  • ☑ For each MRNthe following will be required:
    • Please confirm the date range of study initial signed consent date (start and end dates) to which the monitor will need access.
    • Download a PDF copy of the entire Informed Consent Form (ICF) with signature(s) as required by regulation.
    • Download a signed HIPAA form for each patient included in the checklist, if separate from ICF.
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  • ☑ Informed Consent Form (ICF) Checklist: 
    • Does the study name match the study name on the ICF?
    • Is the Research participant name on ICF matches the request for monitoring?
    • Is the Principal Investigator (or Protocol Director) same as the one listed on the ICF? – If not, have a PDF copy of IRB approval for PI change
    • Is the HIPAA form signed?
    • Does the ICF contains a print name and a signature at the end of the document?
    • Confirm two signatures by adult participant or their legally authorized representative
    • Confirm ICF has signature of the Person Obtaining Consent
    • Confirm the following sections Under Authorization to Use Your Health Information for Research Purposes
      • · The ICF has permit to use the entire medical record
      • · Protocol Director and their research staff are listed as having authorization to use or disclose the information
      • · The study sponsor and its affiliates, representatives, collaborators, etc. and organizations or people who work for or with the study sponsor are listed
      • · Expiration date is not on the same day or in the past
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☑ For Short Form Consent:

  •             If the study has the short form consent confirm that the ICF has the signature of the interpreter
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☑ For Participants Between the Ages 7-17:

  •             Assent form needs to be attached            

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