Patient Awareness Program about Clinical Research

Patient Awareness Program about
Clinical Research
What are the Benefits?
Research Subject’s Rights
● Understand that participation is voluntary.
● Understand your role in the study.
● Ask any questions you might have about your
participation before signing the consent form.
● Leave a study at any time for any reason. However, if
you decide to leave a study, it is important to let the
research team know that you are leaving and your reason.
● Discuss your participation with family members,
friends, or your health care providers.
● Understand potential risks, discomforts and benefits.
● Know what your alternatives are to participate in
a research study.
● Know who is sponsoring the research
study.
What is an IRB?
● An Institutional Review Board or
IRB is a committee of doctors, statisti-
● Participating in a clinical research
studgives you an opportunity to play an
active part in your own health care.
● Receive up to date care from experts.
● Gain access to potentially new research
treatments that you would not otherwise be able to receive y at that
time.
What is a Clinical
Research Study?
A systematic investigation of new
medicines and treatments on specific
health questions involving patients or
healthy members of the public. Helps
doctors find new and better ways to
prevent, detect, diagnose, control, and
treat illnesses.
cians, and community representatives who
review clinical research studies.
● An IRB ensures that studies are ethical.
● Approval by an IRB is mandatory before a
study can begin to enroll participants.
● The IRB serves to protect your rights
and your welfare before and during
the research study.
Some questions you
should ask before you agree
to participate in a research study
● What is the purpose of the study?
● How will it help me?
● Who is carrying out the study?
● Are there extra tests and procedures?
● Will participating in this study affect my
daily life?
● How long is the study expected to last
and how long will I have to take part?
● Will I be informed about the
results of the study?
King Fahad Specialist Hospital-Dammam
King Khalid Medical City -Center for Health Research (KKMC-CHR)
Office of the Institutional Review Board
Phone: +966- 13-844 2222
Ext: 2978/2890/2445/6750
[email protected]
Process of Sponsored Clinical Trials at
King Khalid Medical City
Center for Health Research
Pharmaceutical
Company
Other Sponsors
Center for
Health
Research
(CHR)
Confidentiality Agreement
Pharmaceutical company provides a synopsis
of protocol to CHR director
A confidentiality agreement is signed between
CHR director and Pharmaceutical Company
Protocol Synopsis
Feasibility Assessment
Clinical Research Coordinator will present the
protocol during departmental meeting to assign
a PI and study team members
A meeting between the applicable department
head and the director to discuss the feasibility
of hosting the study
Departmental Meeting
Study Logistics
The sponsor will meet with the PI, study team
& Clinical Research Coordinator/Research
Assistant. The sponsor will collect team members’ CV & finalize the contract with CHR.
IRB
Sponsor Initiation Visit
The study will be executed as per approved protocol
• The Sponsor will send the PI for the investigator
meeting to get training on the protocol.
• The Sponsor will perform an initiation visit to train
research team on protocol.
• The P will keep study master file, receive medication of new trial
Study
Start
• Monitoring completed CRFs, SAEs.
• Auditing at any time.
• Continuing review progress report according to the
protocol.
• Regular Meetings between the PI and CHR every month.
• Meeting with sponsors every quarter or when there is a
problem with patient recruitment or any other problem
related to the study.
Study
END
Site closeout visit
The Sponsor, PI and study team will close the study
when all the analysis and final report is sent to the IRB
King Fahad Specialist Hospital-Dammam
King Khalid Medical City -Center for Health Research (KKMC-CHR)
Phone: +966- 3-844 2222 Ext: 2445/6750/2093
[email protected]