Guidance on Access to Health System Electronic Medical Record (EMR) Systems
for External Research Monitors and Auditors
Interim Guidance – Updated September 2015
Please note that this process is still undergoing modifications with IT and a final guidance document will be available in the near future.
Purpose
This guidance document was developed to assist research teams in obtaining temporary access to EMR systems for the purposes of monitoring or auditing by external research sponsor monitors, auditors or regulatory authorities (e.g. FDA). The following groups have worked to create this guidance document: OCIO and Information Systems (IS), Research Information Services (RIS), Office of Research Compliance (ORC), the Clinical Research Service (CRS), the Medical Group (MG), Ambulatory Services (AS) and the Ambulatory Electronic Health Record (AEHR) Team.
Background
Under FDA regulations for clinical research and Good Clinical Practice (GCP) E6 external sponsors and federal regulatory agencies are required to monitor and audit the conduct of clinical research. The purpose of this activity is to oversee the progress of a clinical trial; ensure the rights, safety and welfare of research participants are adequately protected; and to ensure that the research is conducted, recorded, and reported in accordance with the protocol, GCP, and the applicable regulatory requirement(s). These activities are usually described in contracts and agreements executed with research sponsors.
In order to perform these functions, monitors and auditors require direct access to source documents, which can be contained in both traditional paper and electronic sources, such as EMRs.
· Direct access is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor’s proprietary information.
· Source documents are defined as original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial). Source documents are compared to data collected as part of the research to verify the data’s accuracy and validity.
Process
Research teams must set up an account and request temporary, view-only access to EMR systems for study monitors and auditors well in advance of the visit through IS Help Desk or the online IS forms. An active directory account must be set up for an individual initially, but only has to be set up once. Access to the EMR system should be requested for the duration of the entire study period. Follow the steps as outlined below.
· New Monitor/Auditor: Follow Step 1 and subsequent steps for EMR access for those who have not previously been set up with an active directory account.
· Returning Monitor/Auditor: For those who have had an active directory account set up previously, skip Step 1 and follow steps for requesting access to Sunrise or AEHR. Email the IS ticket # to the Research IS mailbox and inform them that you are requesting access to the EMR for your monitor/auditor.
Step 1: Create Active Directory Account for the Monitor/Auditor:
· Go Healthport
· Select “I Need to” (top of page), select “Submit and IT ticket”
· Select “My request is not listed above” and login with your network credentials.
· Under Accounts and Services select and complete Non-employee Hire for Contractor or Vendor form. Complete this form for one person at a time and complete all mandatory fields.
o For Affected User Name: list the research coordinator’s name (person completing the form)
o For New Hire Name: list the monitor/auditor’s name
o For Account Type: choose “Non-Affiliated Research Staff”
o For Is this an existing Health System Employee: choose “No”
o Fill in the information regarding:
§ The monitor/auditor’s title, company and contact information
§ Start and stop date for access. Note that an individual’s temporary access should be limited to the period of the monitoring visit, NOT the entire length of the study
§ Location of where the research monitoring/audit will occur
§ Copy profile of: Enter Employee - NSLIJ Unlisted
o Fill in rest of form, agree to confidentiality statement and hit submit
· Email the IS ticket # to the Research IS mailbox and inform them that you are requesting access to the EMR for your monitor/auditor.
· You’ll receive confirmation that the active directory account has been created from IS.
Step 2: Request Access to EMR System(s)
Ambulatory Electronic Health Record (AEHR) Access
Requests for temporary access to the system must be made as soon as possible and at least 14 calendar days prior to the visit. Once an active directory and NSLIJHS Network ID are created or existing to gain access:
· Go to Healthport
· Select “I Need to” (top of page), select “Submit and IT ticket”
· Under Request - need something new select I am requesting access to Allscripts EHR
· Complete all mandatory fields.
o For Affected User Name: list monitor/auditor’s name
o For Manager’s Name: enter the Coordinator’s manager or PI name
o For Request Type: choose “New ID”
o For Who is this request for: choose “Employee”
o For Indicate the environments you are requesting access to: select “Production (View Only)”
o Agree to confidentiality statement and hit submit
· Web-based training is required and available through iLearn. The monitor/auditor will receive an email with a link to training. If the monitor / auditor has not received a link please email . The AEHR account will not be provisioned unless the web-based training module is completed. Please have the monitor / auditor save a copy of training completion receipt.
· Email the IS ticket # to the Research IS mailbox and inform them that you are requesting access to the EMR for your monitor/auditor.
Sunrise Clinical Manager (SCM) Medical Record Access
Requests for temporary access to the system must be made well in advance and at least 14 calendar days prior to the visit. Once an active directory and NSLIJHS Network ID are created or existing to gain access:
· Go to Healthport
· Select “I Need to” (top of page), select “Submit and IT ticket”
· Under Request - need something new select I am Requesting Access to Invision, Sunrise Clinical Manager (SCM) and Forms on Demand
· You may complete this form for one person or multiple people. Complete all mandatory fields.
o For Request Type choose: “New ID”
o For Who is this request for choose: “Student”
o For Hospital Facility: choose appropriate facility
o For Student Designation choose: “Research”
o For Student University choose: “Other” and specify name of sponsor or agency
o For 3rd and 4th year Medical Student Names type: “none”
o For Student Names: indicate individuals requiring access
§ Type “(READ ONLY ACCESS)” next to each name you list
§ Indicate start and stop dates access will be required. An individual’s temporary access should be requested for the duration of the entire study period. If multiple people are starting & stopping on different days this may be indicated next to the individual’s name
o Complete rest of form, agree to confidentiality statement and hit submit
· Email the IS ticket # to the Research IS mailbox and inform them that you are requesting access to the EMR for your monitor/auditor.
Staten Island University Hospital (SIUH) Electronic Medical Records Access
Requests for temporary access to the system must be made well in advance and at least 14 calendar days prior to the visit.
· Obtain monitor’s first name, last name and last four digits of the social security #;
· Follow Step 1 above: Create Active Directory Account for the Monitor/Auditor
· Complete the Password Request form available via the SIUH intranet under “useful forms” filling in
o Monitor name
o last four digits of social
o contact # (your #),
o Title (sponsor monitor),
o Location (north, south etc.),
o Department (dept. where the monitor will be auditing),
o Approving manager (coordinator/nurse name and #),
o Access- check off temporary access and place dates the monitor will be completing review,
o Check off all applications which the monitor will need – i.e. STATNET, internet, EMR, EDIS.
The monitor should not sign this form as they are not employees of the health system- only you as the requesting “manager”. This form merely helps identify the applications that will be needed.
Audits or Inspections by Federal Authorities (e.g. FDA)
The same process for obtaining temporary access for monitors and auditors should be followed. However, there may be times during an inspection by a federal regulatory authority when temporary access will be needed much sooner. In these events Investigators must follow the process for facility and administrative notification as outlined in the health system policy, GR027 Preparation for an External Regulatory Research Inspection at a Clinical Site, which is posted on HealthPort and may be accessed here.
To escalate or expedite requests:
· Please call the Help Desk (include any ticket numbers that have been created) at (516) 470-7272.
· For AEHR access: Email your ticket number to “AEHR HDProvisioning” at and explain who the request is for and the need to escalate or expedite.
For Issues:
You may contact the OCIO Joe Baskin at (516) 562-0305/Research IS at or the ORC (516) 321-2101 or for assistance to obtain appropriate levels of access for agency reviewers after notification has been received. Please note it still may take up to 48 hours to obtain a temporary ID and password.
Password resets can only be performed by the IS Help Desk. They can be reached at 516-470-7272 (choose the prompt for Clinical Systems).
Updated September 8, 2015 NS-LIJ Health System Page 3 of 3