Responsibilities during clinical trials
Protection against risks
Deadline and method of notification of the event
INGO shall be notified of an insured event no later than 9 days from the date of the patient's health deterioration. It shall be submitted in the form of a written request of the Insured/representative.
Patient identification
Since the list of insured persons (patients) is not specified when concluding the contract, they are identified directly upon the occurrence of an insured event. After notification of an insured event, the insured person shall provide a copy of the information consent to participate in a clinical trial and his/her identification data.
Terms of settlement of insured events
The insurance indemnity shall be paid within 30 (thirty) calendar days from the date of receipt by the Insurer of all necessary documents.
Benefits of insurance in INGO
outlook - "Evolving"
8.12.2023
What is the maximum limit of liability under the contract?
The maximum limit of liability is set for one person - a patient participating in a clinical trial - and amounts to USD 10,000. US DOLLARS.
What is the mandatory list of documents to be submitted for insurance?
- Study protocol
- Brochure about the study drug
- Example of patient information consent
What is recognized as an insured event under an insurance contract?
- Patient's death
- Establishment of the Patient's disability
- Causing any harm to the Patient's health, not related to the establishment of disability, which does not contradict the exclusions under the insurance contract
Are there any special requirements for clinical trials for which an insurance contract is concluded?
The insurance coverage under the contract includes any actions within the framework of the study that are:
- Are not directly prohibited by the Study Protocol
- Not directly prohibited by the legislation of Ukraine
- Carried out in the interests of preserving the patient's health and life
- Taking into account the recommendations of the State Expert Center of the Ministry of Health of Ukraine for conducting clinical trials
Who is the recipient of the insurance payment?
Depending on the terms and conditions set forth in each individual insurance contract, the recipient of the insurance payment may be the insured person - the patient, his or her legal representative, close relative or heir, or the policyholder.
