If you want to know how to conduct a clinical trial, you should seek advice from EAG (Expert Advisory Group) before proceeding with the trial.
The following guide will give you a better idea on how to apply and the steps you need to take before starting your clinical research.
As part of your application, you must first apply for a unique identifier number which is required for all clinical trials in any EU state. This number can be obtained from EMA website. Once you have downloaded and completed the applicant form through the IRAS website, you are ready to move on to the next stage.
Prior to committing to a research project, feasibility must be evaluated. You need to determine the type of departments that you will be working with such as cardiology, radiology, or pharmaceuticals. As part of your assessment process, you may be asked whether you have qualified staff and the right equipment to run the trial. You also need to decide who will do the paperwork and fill out the report forms.
The initial assessment of your application will be performed within one month. Non-oncology trials are usually assessed within two weeks. You should state in your covering letter that the submission is for phase 1 trial in order to reduce the assessment time.
In observational trials, you assess the health outcomes of your participants according to a research plan. You may give medical products such as drugs or equipment for observation purposes of the effects on their lifestyles.
How Are Participants Protected?
Once you have successfully registered for your clinical study, you need to send informed consent letters to your participants. The informed consent letters provide information about potential risks and benefits of the clinical trial.
In addition to these documents, you may need to give verbal instructions, materials on how to prepare for the study, and FAQ sessions in order to help your participants have a better understanding of your clinical research. Bear in mind that by signing the consent form, the participant is not entering into a contract with you and can withdraw at any time before or during the study.