FAQ
FIND YOUR ANSWER THROUGH THIS QUESTIONS
ELECTRONIC HEALTH RECORD SYSTEM (EHRS)
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
PHASES OF CLINICAL TRIALS (PHASE I, II, III, IV)
- Phase I studies are usually conducted in healthy volunteers. The goal here is to determine what the drug’s most frequent side effects are and, often, how the drug is metabolized and excreted. The number of subjects typically ranges from 20 to 80..
- Phase II studies begin if Phase 1 studies don’t reveal unacceptable toxicity. While the emphasis in Phase 1 is on safety, the emphasis in Phase 2 is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. For controlled trials, patients receiving the drug are compared with similar patients receiving a different treatment–usually an inactive substance (placebo), or a different drug. Safety continues to be evaluated, and short-term side effects are studied. Typically, the number of subjects in Phase 2 studies ranges from a few dozen to about 300
- Phase III studies begin if evidence of effectiveness is shown in Phase 2. These studies gather more information about safety and effectiveness, studying different populations and different dosages and using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people.
- Phase IV trials gather more information about the possible risks and benefits of a drug that didn’t show up in earlier testing. Researchers look into risks and benefits that could be associated with long-term effects after a drug or treatment has been approved for clinical use. In this phase, researchers continue to follow participants who have completed phase III trials. Not all new treatments will enter into phase IV studies
IF YOU HAVE ANY QUERIES REGARDING THE BELOW ITEMS, KINDLY CONTACT
CLINICAL TRIAL CONDUCT
Ms. Hanis Hafizah Ismail (Science Officer)
Contact No: 03 – 7949 2351
Email: hanishafizah@ummc.edu.my
ELECTRONIC HEALTH RECORD SYSTEM
Mdm Anis Athirah Amir Hamzah (IT Officer)
Contact No: 03 – 7949 2351
Email: athirah.ah@ummc.edu.my
FINANCIAL MATTERS
Ms. Noor Aziza Ismail @ Aziz (Accountant)
Contact No : 03 – 7949 2886
Email: aziza.ismail@ummc.edu.my
Mdm. Nur ‘Ain Haris (Account Assistant)
Contact No: 03 – 7949 2886
Email: nurain.haris@ummc.edu.my
CONTRACT/LEGAL MATTERS
Ms. Salmah Ahmad (Legal Officer)
Contact No: 03 – 7931 3161
Email: salmah.ahmad@ummc.edu.my
Mdm. Nurul Ainna Munshi Abdullah (Legal Officer)
Contact No: 03 – 7931 3161
Email: ainna.munshi@ummc.edu.
BUDGET NEGOTIATION
Ms. Nurbazlin Musa (Science Officer)
Contact No: 03 – 7949 2886
Email: nurbazlin@ummc.edu.my
Mdm. Nurul Zfarina Mohd Zaid (Assistant Science Officer)
Contact No: 03 – 7949 2886
Email: nurulzfarina.zaid@um.edu.my
TRAINING AND FACILITIES
Mdm. Nur Hidayah Zakaria (Medical Lab Technologist)
Contact No: 03 – 7949 2351
Email: hiedayah@um.edu.my
Mdm. Anis Nabila Izham (Assistant Science Officer)
Contact No: 03 – 7949 2351
Email: anisnabila@um.edu.my
HUMAN RESOURCE MATTERS
Ms. Nurulhuda Othman (Administrative Officer)
Contact No: 03 – 7949 2351
Email: huda.othman@ummc.edu.my