/clinical/,/clinical/tools-resources/,/clinical/tools-resources/ehr/,/clinical/tools-resources/ehr/health-link/,/clinical/tools-resources/ehr/health-link/research/,/clinical/tools-resources/ehr/health-link/research/erm/,

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Clinical Hub,Tools & Resources,Health Link and Outside EHR Medical Systems,Health Link Info, Tips and Training,Research in Health Link

External Research Monitors (ERM)

External Research Monitors (ERM) - Clinical Hub, Tools & Resources, Health Link and Outside EHR Medical Systems, Health Link Info, Tips and Training, Research in Health Link

Focus

There is a new process available for External Research Monitors to view the patient’s medical record in Health Link!!

This process has been piloted and well received by UW research teams and study monitors. It provides the External Research Monitor (ERM) with their own Health Link user ID and password for view-only access to the full electronic health record, restricted to specific patient records. It does require that the study team have writable Health Link access, since the study coordinator plays a key role in populating the ERM’s InBasket with their specific study subjects.

This process is highly encouraged, but not required. Other options include printing, or an over-the-shoulder approach. For the over-the-shoulder method, it is NEVER acceptable to share your password or leave the Monitor unattended. YOU must be at the helm.

Please note: the study account will be assessed a $50 charge per laptop use. This flat rate is designed to cover the expense of the laptops and operation of the program. Study groups are encouraged to incorporate this fee into their budgets with their sponsors.

If you are interested in utilizing this process for future monitoring visits, please review the resources below (also found in the Resources tab on this page). Please do not maintain your own copies, but rather utilize the links below to ensure you always have the most current version of each.

Note: There is no appendix D.

FAQ

Who do I call for help?

Please assure your monitors are instructed to call you directly with any questions about using the laptops or logging in to Health Link. As needed, only research coordinators should call the help desk at 265-7777 to request assistance.

If you have any questions or issues with the monitor’s login to Health Link, please call the Help Desk at 265-7777 and request to be directed to the IS Security Team.

If any questions or issues come up that are not access/login related, please contact Tammy Kiger at TKiger@uwhealth.org or (608) 890-6667.

Are there other options for a Monitor to gain access to a patient’s medical record?

There are currently 3 options available for a Monitor’s review of a patient’s medical record, including over-the-shoulder, printed medical records and use of the Health Link InBasket process. For the over-the-shoulder method, please note it is NEVER acceptable to share your password or leave the Monitor unattended. YOU must be at the helm.

In which conference rooms can the Monitor use the laptop?

Laptops are configured to only use the UWHC wireless connection, which has been confirmed for the following conference room locations:

Online room reservations can be made via the UW-SMPH HSLC website.

Reminders: 

What if a monitor shows up unexpectedly?

Follow Appendix B to submit a Service Now ticket to complete a “Computer Systems Access Request” for the ERM and then call the Help Desk at 265-7777 to inform them of your urgent request and ask them to page the Systems Security Team. Alternatively, you could use an over-the-shoulder approach.

Can InBasket access still be granted to ERMs who come for regulatory or source doc review visits once a subject is no longer on study?

If the subject withdrew study consent, then the ERM should only be allowed to view the patient’s record via printing or over-the-shoulder to ensure they only see Patient Health Information up to the point when the consent was withdrawn. However, if the subject is just no longer on the study, then there is no expiration on accessing the patient’s records.

The Assurances Document is signed by the RC, but shouldn’t the ERM sign a similar document recognizing their responsibility to maintain confidentiality and laptop security?

This isn’t necessary because ERMs are already operating under a professional conduct agreement.

How do I know whether the patient’s old paper medical record has been scanned into Health Link?

If the “paper chart” tab is populated in Chart Review (in Health Link), then the entire paper record has been scanned.

To meet Good Clinical Practice requirements, do we still need to print and have the PI sign-off to say that they have seen and reviewed the labs and procedures related to a study or is a note in the patient’s chart (from the provider) sufficient?

Please continue to follow current processes (print & sign).

Does the ERM still need to register with the Vendor Liaison Office (VLO)?

No, the laptop request form is sufficient; but if no laptop is requested, then you need to follow the process outlined on the VLO department page on U-Connect.

AEs and con meds sometimes change after the subject’s last research related visit. How do I ensure I am aware of these changes before a Monitor’s visit?

Before the monitor’s visit begins, we recommend you review the patient’s recent encounters (e.g. clinic & telephone) so you know what has occurred since the last research-related visit (e.g. possible AE, new meds, etc.). Also, per GCP and overall patient safety, you are encouraged to review the patient’s medication list in Health Link and work with the UWHC/MF clinical staff to update as needed. This will help ensure your med list does not conflict with the patient’s medical record. In addition, you may want to consider writing a memo to file for each study indicating your “con med list is the source that should be used for the purposes of this monitoring visit”.

Resources

Guidelines

Process Instructions

Supporting Documents

Appendix A: Laptop Request Form (fillable Word document)