About the Clinical Trials Unit
The Clinical Trials Unit (CTU) at KHCC manages and supports all clinical trials at the Center in compliance with institutional, local, and international regulations governing the conduct of clinical trials.
The CTU:
- Works closely with all departments to investigate the feasibility of each clinical trial and its importance to KHCC patients.
- Works to develop, implement, and improve policies and procedures related to the conduct and management of clinical trials at KHCC in compliance with Good Clinical Practice (GCP) guidelines.
- Facilitates interdepartmental communication between members of the trial team.
- Supports communication with the sponsor, local regulatory bodies, and IRB.
- Oversees audits and inspections on ongoing clinical trials.
Clinical Research Coordinators (CRCs)
Clinical Research Coordinators at KHCC are responsible for:
-
Organizing and coordinating the implementation of clinical trial protocols through:
- supporting patient accrual and follow-up visits
- patient education and support
- management of investigational products (shipment, storage, dispensing, retention, return, or destruction)
- collection and shipment of study-related samples
- data management activities (extraction, collection, entry, verification and retention)
- retention of data
- handling of trial samples and products
- maintenance of trial master file, archiving, and reporting including adverse events.
They are engaged in continuous education programs at KHCC and are required to sit for the Association of Clinical Research Professionals certification exam after two years of work at KHCC to become certified clinical research coordinators.
Examples of ongoing clinical trials at KHCC:
|
ID |
Indication Area |
Sponsor |
Phase |
Principal Investigator |
IRB # |
Status |
|---|---|---|---|---|---|---|
|
1 |
Colon Cancer |
Sanofi-Aventis |
Registry |
Sameer Yasser |
06 KHCC E08 |
Running |
|
2 |
Gastroenteropancreatic Neuroendocrine Tumor |
Novartis |
Registry |
Salah Abbasi |
09 KHCC 69 |
Running |
|
3 |
Metastatic Recurrent and/or Unresectable Renal Cell Carcinoma |
Novartis |
II |
Faisal Al-Badaineh |
09 KHCC 58 |
Running |
|
4 |
Colorectal Cancer |
Sanofi-Aventis |
Registry |
Yasser Yamin |
09 KHCC 59 |
Running |
|
5 |
Herpes Zoster |
MSD |
III |
Lina Marei |
11 KHCC 05 |
Pending Start |
|
6 |
Venous Thromboembolism |
Sanofi-Aventis |
Epidemiological |
Hikmat Abdel-Razeq |
11 KHCC 47 |
Running |
|
7 |
Non-Squamous Non-Small Cell Lung Cancer (NSCLC) |
Roche |
Epidemiological |
Salah Abbasi |
11 KHCC 49 |
Running |
|
8 |
Venous Thromboembolism |
Investigator-initiated |
Registry |
Hikmat Abdel-Razeq |
11 KHCC 67 |
Running |