Preparation & Requirements
KFSH&RC Forms
- Cover page
- Investigators Assurance & Declaration of Conflict-of-Interest Form
- Proposal Clearance Form
- Budget Form (for sponsored Research only)
- Pharmacy Information Letter
- Consent Form for Interventional Studies (Bilingual EN & AR)
- Consent Form for Genetics Studies (Bilingual EN & AR)
- Certificate of Assent of the Minor - Arabic
- Certificate of Assent of the Minor - English
- Clinical Trial Agreement (CTA) (any required agreements as well)
- Material Transfer Agreement (MTA)
- Prelim Budget Excel Sheet
Work Plan Template
Other requirement: KFSH&RC Forms
- Study Protocol (not a synopsis)
- Case report form (electronic CRF completion guide)
- Subjects “Questionnaires” or “Thank You” cards, or Patient Materials
- Subject Insurance certificate
- National Committee of Bio Ethics (NCBE) Form
- Financial Disclosure Forms (FDFs)
- Letter List of documents
- If there is any Subject Information form (Bilingual EN & AR)
- Investigator Brochures
Donation and volunteering
Volunteers are an integral part of the research process. Many different types of people take part in clinical research. Some are healthy, while others may have illnesses. People volunteer for
clinical studies to help doctors and researchers learn more about disease and improve health care for people in the future.