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Sponsor monitors are allowed to access the Yale enterprise-wide Electronic Health Record (EHR) for source data verification, both on-site and remotely.
A 2-week advance notice period is required to ensure access agreements are signed and to allow the Health Information Managements Department time to grant appropriate EHR record access.
The following steps should be taken to request EpicCare Link access for your monitor.
Obtaining Access
1. Confirm that the trial’s Sponsor has signed a “Research Use EpicCare Link Site Access Agreement.”
If the trial’s sponsor is not listed, please submit a YCCI Service Request to initiate a new EpicCare Sponsor Agreement.
2. Once the Sponsor agreement is confirmed to obtain system access, prior to the initial monitoring visit, email with a cc to the monitor, the following documents to Health Information Managements Dept at EpicCare.eHIM@ynhh.org
a. The completed “Yale New Haven Health System Research Confidentiality and Responsibility Agreement” signed by the monitor.
b. The completed signed “YNHH Research Monitor Request for EpicCare Link Access” by the Principal Investigator.
c. The most recent IRB approval letter. If the IRB of record is an external IRB, include the Yale IRB deferment letter with the IRB approval letter.
3. Save the documents in the trial regulatory binder.
Prior to Each Scheduled Monitor Visit
A minimum of 5 business days prior to each scheduled monitor visit, email EpicCare.eHIM@ynhh.org requesting access be provided for all consented study participants to the trial, including the following information:
- Protocol#: (Provide the full HIC# for the trial(s))
- Sponsor Name (Provide Sponsor name)
- Monitor’s Name: (First name) (Last name)
- For the following date(s): From (enter first date of monitor visit) through (enter last date of monitor visit)
- Study Patient Information: MRN: (List all here)