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ABOUT the CIO Newsletter:
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This is the 72nd broadcast communication featuring news and information related to CRIS and ancillary applications as well as general IT and DCRI news for the Clinical Center community.

Have a comment or suggestion about the Newsletter?
Contact us at CIOnewsletter@cc.nih.gov


Department of Clinical Research Informatics
National Institutes of Health
Building 10, 10 Center Drive
Room 1C290,
Bethesda, MD 20892-1172



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CRIS Reference Materials

 


CIO Remarks    

Protocol Attribution

Protocol attribution is an important process used at the Clinical Center in order to align medical orders and Clinical Center Services to a specific patient and their appropriate research protocol.

Key elements include:

  • Assignment of the patient to an active and approved NIH protocol, as documented in CRIS.
    This allows for participation in research and receiving of medical care.
  • Accurate attribution/allocation to the correct protocol when placing each medical order.
    For example, when a patient is assigned to multiple protocols, the correct protocol must be chosen for each individual action (i.e. placing of medical order).
  • Utilization of the informed consent process with each patient for each protocol to which they are assigned.
  • A requirement for entering ATV requests, scheduling appointments, and placing medical orders.

    Small image of Protocol Attribution Poster
    Protocol Attribution Poster
    Large Version
    PDF Icon (135 KB)

  • Provides clinical research teams with accurate data for analysis and hypotheses.
  • Ensures and tracks delivery of appropriate medical care to patients.
  • Provides patient census and clinical activity data to the Clinical Center and Institutes/Centers for resource management.
  • Provides accurate data for the Biomedical Translational Research Information System (BTRIS).
    The process of protocol attribution is a cyclical one which follows the patient through their entire treatment at the CC. Clinicians are key to the success of this system and we thank you for your active participation.

More information and details can be found at: http://cris.cc.nih.gov/cristraining/documents/CRIS_Protocol_Attribution.pdf

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Pharmacogenomics Testing at the Clinical Center   

Part I

The CC will initiate a formalized pharmacogenomics testing program on Wednesday, September 19, 2012.

The first part of our program is directed at improving medication safety by reducing the chance for severe hypersensitivity reactions (i.e. fever, hypotension, skin rash, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, erythema multiforme) where HLA gene variations predict for these reactions.

The first three drugs and the associated gene variations to be included in this program are:

Abacavir
(HLA-B*5701)

Patients with HLA-B*5701 should NOT receive abacavir because there is a high predictive value of developing a severe hypersensitivity reaction.

Allopurinol
(HLA-B*5801)

Carbamazepine
(HLA-A*3101 or
HLA-B*1502)

For allopurinol and carbamazepine, consideration should be given to selecting other agents first.�

Patients with these gene variations can still receive these medications, if the clinical benefit is thought to outweigh the risks.� In this situation, a clinical justification is required as part of the CRIS order.

HLA tests (Sequenced Based HLA-A, Sequenced Based HLA-B) can be ordered in CRIS. The tests will be done by the Department of Laboratory Medicine with an expected turn-around time of about two weeks.

Clinical Decision Support in the form of Order set forms will be used to assist with the ordering of these medications. Please note that these orders can only be placed by a prescriber and cannot be re-ordered.

When you open the item for any of these three medications you will see a different view.

Form Part 1 Screenshot

There are three parts to the form:
          1. A Place for an Override Reason
             a. An override reason is only needed

                  i. if the HLA result from NIH is pending

                  ii. if the HLA result is positive, but the clinical benefit outweighs the risk

                  iii. if the HLA result is available from an outside lab and the result is negative

                  iv. if the HLA result is not yet ordered and there is clinical justification documented in CRIS

Form Part 2 Screenshot

          2. A Place to order the HLA lab test
             a. If an HLA test has not yet been ordered, you can place the order from within this form by                        selecting the checkbox next to the lab test listed.

             b. If a result is pending or if the result is available, you will not be able to enter another lab                         order.

Form Part 3 Screenshot

           3. A Place to order the medication
             a. From this order form you can enter the medication order.

                  i. Please remember to select the correct session type before you begin to complete the                         other elements.

                  ii. If you are not in the correct session type, you will have to cancel, exit the order, select                        the session type, and start the process again.

Form Part 3 Screenshot

Questions about pharmacogenomic tests can be directed to the Clinical Pharmacy Specialist (CPS) for your unit or to the Drug Information Service (301.496.2407) if a CPS Is not assigned to your area.

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Renewing PIV Card Certificates   

Renewing digital certificates on your HHS ID Badge/PIV Card ? PKI digital certificates on the HHS ID Badge/PIV Card are valid for 2 years for employees and 1 year for contractors. HHSIdentity will send an email reminder to users with instructions on how to renew your digital certificates 42 days before the user's certificate expires. Please follow the instructions and contact an LWS operator to assist you. You must appear in person with your card to renew the certificates. Failure to renew your digital certificates by the expiration date provided in the email will prevent users from using their HHS ID Badge/PIV Card to login to ITAS, NIH VPN, CCCASPER for remote access and sending/receiving secure email in Outlook.

Once the certificate is renewed, it will be necessary to publish the new certificate to the GAL to continue using secure email. It will be necessary to backup or recover certificates to read old encrypted emails. Please refer to the documents that will be provided by the LWS operator for guidance or contact your desktop support person for assistance.

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NIH Password Management   

Keep your NIH passwords up to date - NIH will be implementing the requirement to use your HHS ID Badge/PIV Card to login to the NIH network on Windows workstation on campus this year. Some Institutes/Centers already require this for their Windows users.

Even though you are using your HHS ID Badge/PIV Card to log in to your computer, it is still necessary to update your password to keep your AD account active. According to the NIH OCIO, as long as NIH continues to use username/password authentication with Active Directory, the password change policy will apply. AD will not allow you to login to a computer (with or without a PIV card) if your password is expired. This policy is expected to remain in effect for at least 2 more years.

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CRIS Helpful Tips    Screenshot of Printing in Citrix pdf file Screenshot of CRIS Printer Mapping Document

CRIS Printing from CITRIX

When a user connects to CRIS Sunrise through Citrix using the cccasper portal(https://cccasper.cc.nih.gov), the user's default desktop printer should map with their connection. This will allow the user to print from CRIS Sunrise using their default printer.

 

Instructions on how to print from CRIS via Citrix
can be found at the following URL: http://cris.cc.nih.gov/cristraining/documents/CRIS_Printer_Mapping_CITRIX.pdf PDF Icon (276 KB)

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    CRIS Support    

    Need assistance for CRIS technical or clinical questions?
    Feel free to call CRIS Support at (301) 496-8400.

    CRIS User Support is available 24/7.

    • Business hours: Monday ? Friday from 7:00 am ? 5:00 pm.
      A CRIS support person will take your call and will either resolve the issue(s) OR determine if additional resources are needed to assist.
    • After hours: After 5:00 pm ? 7:00 am, weekends and holidays.
      If you call CRIS Support, a recording will play directing you to either leave a message or press 1 for immediate assistance. By pressing "1" you will reach a live in-house resource people to assist in your needs.

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    NOTE: PDF documents require the free Adobe Reader.