SOALAN LAZIM

Does the UMMC Electronic Health Record System (EHRS) have Health Information Technology certification for the Economic and Clinical Health Act 2009 (HITECH Act) – a voluntary certification program for health IT.
Not Available

SITE HEALTH ELECTRONIC / HEALTH RECORDS

Access to electronic health records (EHRS) systems is restricted to authorized users
Yes

Author of e-record can be identified
Ya

An audit trail is available to track changes to the data
Execution in progress

E-records are available and maintained for inspection and/or regulatory audits to the extent required by applicable local regulations.
Yes

PHYSICAL SAFETY

Institutions have an electronic copy or backup mechanism to protect patients’ electronic records in the event of an unexpected event
Yes

ACCESS MANAGEMENT AND PASSWORD MANAGEMENT

EHRS will be reviewed electronically by the Roche Clinical Research Associate / SOR during the on-site monitoring visit, a user ID and password will be provided and access privileges will be limited to “view-only” or “read-only” data for patient data.
Yes

The information is properly listed on the Source Document Location Form (or similar site)
Yes

CONTROL DATA/AUDIT CHANGE CONTROL

EHRS has a computer-generated “timestamp” that records the date and time and the person who made all the entries, changes, and deletions in the patient’s electronic records.
Yes

Audit trail is available upon request of a regulatory agency or Sponsor audit or inspection
Yes

ARCHIVING

All electronic records be stored in accordance with ICH GCP and relevant local regulations
Yes, relevant local regulations

Confirmation that if technology changes, site will maintain adequate hardware to retrieve records throughout the required retention period
Yes

There is adequate documentation of what electronic records have been stored and where they are located in the event they need to be retrieved after the study is concluded (Note if this is listed on Source Document Location Form or Other)
Yes