Sidra IRB

Sidra Medicine’s Institutional Review Board (IRB) is a pivotal entity ensuring the ethical conduct of human subject research within the institution. It operates under the guidelines set forth by the Ministry of Public Health (MoPH) in Qatar and adheres to international standards such as the Belmont Report and the International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines.

🔍 Overview of Sidra Medicine’s IRB

• Ethical Oversight: The IRB is responsible for reviewing all human subject research conducted at Sidra Medicine, regardless of funding source, to ensure the protection of participants’ rights, dignity, welfare, and privacy. 
• Compliance: Sidra Medicine’s IRB policies and procedures align with MoPH’s regulations and international ethical standards, ensuring that research activities meet both local and global requirements.
• Review Authority: The IRB has the authority to approve, require modifications in, or disapprove research activities involving human subjects. This includes initial reviews, continuing reviews, and the assessment of any changes to approved research protocols. 
• Informed Consent: A key aspect of the IRB’s function is to ensure that informed consent is obtained from all research participants or their legal guardians, with special considerations for vulnerable populations such as children.

📋 Submission and Approval Process

1. Protocol Submission: Researchers must submit their study protocols, informed consent documents, and any other relevant materials to the IRB for review.
2. Ethical Review: The IRB reviews submissions to assess the ethical implications, potential risks, and benefits to participants, ensuring that the study complies with ethical standards. 
3. Approval: Upon satisfactory review, the IRB grants approval for the study to proceed. Researchers must obtain this approval before initiating any research activities involving human subjects.
4. Ongoing Oversight: The IRB conducts continuing reviews of approved studies, monitors compliance, and reviews any proposed changes to the research protocols.

📞 Contact Information

• IRB Registration: Sidra Medicine’s IRB is registered with the MoPH under the code IRB-SIDR-2020-009, with the current registration valid until September 10, 2027. 
• IRB Chairperson: Dr. Ayman Saleh 
• Contact Email: asaleh2@sidra.org 

For more detailed information on the IRB’s policies, submission guidelines, and procedures, please visit Sidra Medicine’s Clinical Research page: Sidra Medicine Clinical Research.

If you require assistance with the IRB submission process or have specific questions about conducting research at Sidra Medicine, feel free to ask!

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Dr. Ayman Saleh is a distinguished physician and researcher specializing in pediatric hematology, oncology, and bone marrow transplantation. He currently serves as the Division Chief of Pediatric Hematology-Oncology & Bone Marrow Transplant at Sidra Medicine in Doha, Qatar. In addition to his clinical leadership, Dr. Saleh holds the position of Chairman of the Institutional Review Board (IRB) at Sidra Medicine, where he oversees the ethical conduct of clinical research within the institution. 

With over three decades of experience in pediatric medicine, Dr. Saleh has held multiple leadership roles throughout his career. Prior to joining Sidra Medicine in 2017, he served as the Division Chief of Pediatric Hematology Oncology from 1998 to 2011 and as the Medical Director and Chairman of the Department of Pediatrics from 2005 to 2007. His extensive experience includes chairing various committees such as the cancer care committee, credentialing committee, pediatric academic review committee, pediatric executive committee, standing committee of the board, and professional affairs committee. 

Dr. Saleh is also an active researcher and has been a full member of the international Children’s Oncology Group (COG) since its inception in 2000. He has conducted numerous clinical trials and received multiple grants focusing on childhood cancer, hemophilia, hemoglobinopathies, and supportive care. His contributions to the field have been recognized with several awards, including the American Cancer Society Fellowship Award, Children’s Miracle Network Award, and the Hemophilia Grant Award funded by the Maternal and Child Health Bureau and the Centers for Disease Control and Prevention of the U.S. 

For more detailed information about Dr. Ayman Saleh’s professional background and contributions, you can visit his profile on Sidra Medicine’s official website: .

Building CRO in Middle East

To operationalize a Contract Research Organization (CRO) in Qatar, it’s essential to engage with specific regulatory and institutional bodies that oversee clinical research activities. Below is a structured guide to the key entities and steps involved:

🏛️ Key Regulatory and Institutional Bodies in Qatar

1. Ministry of Public Health (MoPH) – Health Research Governance Department
3. Role: Primary regulatory authority for clinical research in Qatar. Responsible for approving clinical trials and ensuring compliance with ethical and scientific standards.
4. Requirements:
6. Obtain approval from the MoPH before initiating any clinical trial.
7. Ensure the research institution is accredited by the Health Research Governance Department.
8. Maintain a registered Institutional Review Board (IRB) under the Health Research Governance Department.
9. Application Process:
11. Submit an application form for clinical trial approval.
12. Provide an approval letter from the IRB.
13. Include a recommendation letter from the Data Safety and Monitoring Committee.
14. Attach the clinical trial protocol and informed consent form.
15. Reference:  
16. Institutional Review Boards (IRBs) / Independent Ethics Committees (IECs)
18. Role: Review and approve clinical trial protocols to ensure the protection of human subjects.
19. Requirements:
21. All clinical trials must receive prior approval from a registered IRB/IEC.
22. Ensure compliance with ethical principles originating from the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines.
23. Reference:  
24. Hamad Medical Corporation (HMC)
26. Role: Qatar’s largest public healthcare provider and a significant site for clinical research.
27. Requirements:
29. Collaborate with HMC for access to clinical trial sites and patient populations.
30. Engage with HMC’s research administration for support and guidance on conducting research within their facilities.
31. Reference:  
32. Sidra Medicine
34. Role: Specializes in pediatric and maternal health research.
35. Requirements:
37. Coordinate with Sidra’s IRB for studies conducted within their institution.
38. Focus on clinical trials that benefit children in the Arab region, particularly those with rare diseases.
39. Reference:  

✅ Steps to Operationalize a CRO in Qatar

1. Institutional Accreditation
3. Ensure your CRO is accredited by the MoPH’s Health Research Governance Department.
4. Register your Institutional Review Board (IRB) under the same department. 
5. Protocol Development
7. Design clinical trial protocols adhering to ICH-GCP guidelines and ethical standards.
8. Prepare comprehensive documentation, including informed consent forms and data management plans.
9. Ethical Approval
11. Submit the clinical trial protocol to a registered IRB/IEC for ethical review and approval. 
12. 
    
13. Regulatory Submission
15. Apply for clinical trial approval through the MoPH, providing all necessary documentation and approvals.
16. 
    
17. Site Collaboration
19. Establish partnerships with institutions like HMC and Sidra Medicine for access to research sites and patient populations. 
20. 
    
21. Compliance and Monitoring
23. Implement quality management systems to ensure ongoing compliance with regulatory requirements.
24. Conduct regular audits and monitoring of clinical trial activities.

By engaging with these key bodies and following the outlined steps, you can effectively establish and operate a CRO in Qatar, ensuring compliance with local regulations and contributing to the advancement of clinical research in the region.

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Building CRO

Building a Contract Research Organization (CRO) service requires a mix of scientific expertise, regulatory knowledge, operational efficiency, and client-centric business development. Here are the key elements to focus on:

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1. Service Portfolio Design

• Core Services: Clinical trials (Phase I–IV), regulatory affairs, data management, biostatistics, medical writing, site monitoring.

• Specialized Services: Pharmacovigilance, bioanalytical lab services, patient recruitment, decentralized trials, etc.

• Therapeutic Focus: Oncology, neurology, rare diseases, etc., depending on your expertise.

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2. Regulatory Compliance

• Adherence to ICH-GCP, FDA, EMA, and local health authority regulations.

• Ensure processes align with 21 CFR Part 11 (electronic records/signatures).

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3. Talent & Expertise

• Hire clinical research professionals, project managers, data scientists, regulatory specialists, and medical experts.

• Emphasize continuous training and certifications (e.g., GCP, CRA, PMP).

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4. Technology Infrastructure

• Clinical Trial Management System (CTMS)

• Electronic Data Capture (EDC)

• Randomization and Trial Supply Management (RTSM)

• AI-powered tools for patient recruitment, trial design, and remote monitoring.

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5. Quality Management System (QMS)

• Develop SOPs for all functions.

• Implement audit trails, CAPA systems, and risk-based monitoring.

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6. Site Network & Patient Access

• Build relationships with hospitals, clinics, and investigators.

• Consider strategic partnerships or alliances to access global sites.

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7. Business Development & Partnerships

• Offer competitive pricing, flexible models (full-service or FSP).

• Build long-term relationships with sponsors—biotech, pharma, or academia.

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8. Data & Security Infrastructure

• Ensure data integrity, HIPAA/GDPR compliance, and robust cybersecurity.

• Leverage real-world data and eSource technologies for speed and quality.

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9. Global Reach & Localization

• If aiming for global trials, ensure regional regulatory expertise and multilingual teams.

• Understand cultural, logistic, and regulatory differences across geographies.

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10. Reputation & Trust

• Demonstrate success via case studies, KOL endorsements, and trial performance metrics.

• Maintain transparency and ethical practices.

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Would you like a sample org structure or roadmap to launch a CRO startup?

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