What is informed consent form?
We sure that our Hospital performs international clinical trials effective on a very high level. But patient decision to participate in clinical trial has to be voluntarily and free of will.
Informed consent form (IFC) for international clinical trial if the first and the main step patients do before treatment starts. According to international requirements, given procedure is obligatory to perform in each hospital and investigative site.
ICF will be provided to patient in language he or she understands and for the time he or she needs. There is not pressure on patient while decision considering. At the same time, investigators can give patient any additional information he or she requires.
See what information is included in ICF:
- Name of the trial and its international number.
- Name of the Sponsor-Company.
- Name of the investigator responsible for clinical trials conduction at site (Principle Investigator)
- Hospital address.
- Telephone number of ICF, in case patient has questions concerning rights protection.
- Aim of the trial and presumptive results.
- What analysis will be taken, how often and where they will be processed.
- Diagnostic procedures: computed tomography assessment, bone scan, mammography, ultrasound examination, X-ray and others.
- Procedures (both diagnostic and treatment)
- Procedure schedule.
- Duration of the trial. It should be noted that duration of treatment is strictly stated in ICF. Recommendations are given for each patient after trial end.
- Disease under study.
- Drug and technologies used during trial.
- Risks and benefits.
- Adverse events and its frequency. Data will be provided for all expected adverse events. Even if adverse event expectation is poor, it will be provided in ICF. It has to be noted that adverse events frequency arisen during clinical trials is 5-8 time lower than while receiving common drugs.
- Contraception methods (for both men and women).
- Investigator’s contacts.
- Phone number of the patient or his/her relatives, or patient’s representative.
- Contacts of district or family doctor.
- All expenses. Expenses arisen during treatment are covered by Sponsor-Company, since oncological drugs are highly expensive but patient’s, participating in clinical trials, receive these drugs free of changes.
- Personal data protection. Received, during trials, data is entered in special record forms with authorized and limited access. Such data cannot be transferred to third parties.
- Signing part. Patient can take as much time as her or she needs for decision making, ask all questions and discuss it with relatives. Document is signed by both patient and investigator.
Patient has the right to withdraw consent any time during the trial. This statement is also provided in ICF. Such decision does not affect the possibility to participate in other clinical trials.
Our investigators provide full information about technical capabilities of out Hospital, staff qualification and comfort awaiting for patients. Investigators are also obliged to give information about alternative methods of treatment. One should remember that participation in clinical trial is always a patient decision.
