- Contract negotiation
The negotiation process for commercial clinical trial contracts begins after study protocol submission to Ichilov’s Helsinki Committee.
- Clinical Trial Budget
Budget must cover all study expenses, including:
- Storage and delivery of study drugs and special preparations
- Personnel: Sub-Investigators, a research coordinator, technicians.
- Hospitalizations/special surgeries within the framework of the study
- Professional counseling by various hospital departments.
- Laboratory, imaging, pathologies etc.
- Overhead (18%)
*Note: When the principal investigator is the study sponsor, and the company provides the research product (drug and/or Medical Device), it must be ensured that the company:
1. Provides the drug in a quantity appropriate for the expected number of participants.
2. Is responsible for the nature and quality of the drug.
To be eligible for Helsinki Committee approval, a budget compliant with the abovementioned requirements must be submitted to the Commercial Contracts Committee via the Israeli Ministry of Health’s online form.
- Liability insurance agreement
- Committee Approval & Trial Fund Management
Following Committee approval, clinical trial approval is granted by Ichilov’s Hospital Director through a signed Form 7.
Once approved, a dedicated research fund will be opened through which all trial funds will be managed.