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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

FLOWCHART ON HOW TO CONDUCT CLINICAL TRIAL THROUGH CIC
GUIDELINE FOR APPLYING MEDICAL ETHICS COMITTEE
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
I-RESEARCH APPLICATION

Mr. Banusanthar Lohanathan(Science Officer)
Contact No: 03-7949 2351
Email: banusanthar@ummc.edu.my

 

Ms. Khairulbariah Baharum(IT Officer)
Contact No: 03-7949 2351
Email: khairulbariah@ummc.edu.my

FINANCIAL MATTERS

Ms. Noor Aziza Ismail @ Aziz(Accountant)
Contact No : 03 7949 2886
Email: aziza.ismail@ummc.edu.my

 

Mdm. Nur Fathin Maisarah Azami (Account Assistant)
Contact No : 03 7949 2886
Email: fathinm@ummc.edu.my

 

Mdm. Nur ‘Ain Haris (Account Assistant)
Contact No : 03 7949 2886
Email: nurain.haris@ummc.edu.my

LEGAL MATTERS

(CLINICAL TRIAL AGREEMENT)
Ms. Nurul Najihah Saupi (Legal Officer)
Contact No : 03 7949 2886
Email:  najihah.saupi@ummc.edu.my

 

Ms. Nahra Yasmin Anuar (Legal Officer)
Contact No : 03 7949 2886
Email:  nahra.anuar@ummc.edu.my

BUDGET NEGOTIATION

Ms. Juliana Wang Piek Lian (Science Officer)
Contact No : 03 7949 2886
Email: wangpl@ummc.edu.my

 

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

 

Ms. Hanis Hafizah Ismail(Science Officer)
Contact No: 03-7949 2351
Email: hanishafizah@ummc.edu.my