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Before you become a clinical investigator, you should be thoroughly familiar with all governmental regulations and identify a secure a location for the trial to be held. Find a clinical trial that interests you and complete the documents needed to begin the study. You must also have the study facilities inspected and receive approval from an institutional review board before you can become a clinical investigator. Your sponsor should then visit your study site and sign a contract to officially begin the clinical trial. Recruit and enroll study participants and learn as much as possible during the trial.
It is very important to familiarize yourself with all governmental regulations before you become a clinical investigator. In the United States, for example, the Code of Federal Regulations defines the responsibilities of investigators, sponsors, and institutional review boards. Additionally, you must be aware of good practices which protect the well-being, rights, and privacy of all clinical study participants. These rules also ensure that important data from the trial is collected and reported in a reliable manner. Clinical investigators must be in compliance with these regulations for the duration of the study.
You must also secure an adequate study facility before you become a clinical investigator. This facility must be able to house drugs, archives, and equipment as well as research workspace. Practicing physicians may be able to utilize a portion of their own office for this purpose. Hospitals will sometimes donate unused space for the duration of the trial. In addition to a study facility, you must also hire a clinical research coordinator to manage and document the study.
Next, find a clinical trial that interests you and submit your application. It is best to search within your budget and particular area of expertise. A comprehensive list of proposed clinical trials is available on the Internet. You can also submit your credentials and contact information to an online clinical investigator database. After selecting a suitable clinical trial, you must complete and submit all essential documents. These documents typically include disclosure agreements, laboratory certifications, financial information, and curriculum vitae for all research personnel.
Your clinical trial facilities must be inspected by a sponsor representative prior to beginning the study. Your interest, experience, site, staff, and patient population will be evaluated during this inspection. The representative will also determine if you will be conducting any competing studies during the clinical trial period. An institutional review board must approve the study site as well. This board is responsible for protecting the rights of all clinical trial participants.
The clinical trial site must also be inspected by your sponsor before beginning the study. A contract between you and your sponsor must be agreed upon and signed prior to this inspection. This contract will set forth the number of participants you must enroll, registration timelines, regulatory requirements, and a financial compensation plan. The next step is to recruit and enroll study participants and begin the clinical trial itself. A clinical trial is an opportunity to gain new skills, and you should try to learn as much as possible during the process.
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