Clinical Research arm provides support to KHCC staff with sponsored clinical trials and investigator initiated clinical research projects. CRRO offers a wide range of services to researchers at KHCC. Services aim at supporting research activities by facilitating better management of research, ensuring quality data and reliable results and offering training in research methodology for KHCC staff.

a. Sponsered Studies:

For sponsered studies, CRRO serves as a single point of contact between KHCC investigators and clinical trials sponsors. That is, CRRO will take the responsibility of

• Handling all administrative work, including  contracting and budgeting phases of study start-up, navigate the IRB approval processes

• Contacting the appropriate department to explore study feasability and to name an investigator

• Providing study coordinator services to conduct patient visits and sponsor monitoring process. 

In the last two years, KHCC witnessed an increasing interest of pharmaceutical companies to conduct studies.

b. KHCC initiated studies:

Conducting reseach study is a great learning experience, especially for junior staff,  to practice scientific methodology in research while following  research values and ensuring human protection. CRRO provide support and guidance to researchers prior to IRB approval until publication/presentation as follows:

• Pre-IRB Approval Services:

1.      The Study design: The biostatistician helps investigators to design the study, set the hypothesis, calculate sample size, and prepare the data analysis plan.

2.      Consultation services: the Clinical Research Coordinator (CRC) assists investigators by reviewing the protocol and identifying endpoints and data to be collected in order to achieve study objectives.

3.      Scientific Review of proposal: CRRO staff review and assess the scientific elements of proposal, study conduction procedures and data analysis plan. 

      
             IRB Committee members at KHCC

• Post-IRB Approval Services:

1.      Enrollment and consenting of patient in prospective studies.

2.      Creation of data base and designing the data collection sheet or Case Report Form

3.      Data Collection and data cleaning to ensure reliable data.

4.      Statistical analysis and writing the results’ section of an article/ report.

5.      Review articles prior to submission.