How to Work as a Principal Investigator (PI) for a Clinical Trial

The principal investigator is the doctor/physician/licensed medical practitioner who is in charge of a clinical research study or project. This person is the lead investigator for the study. The principal investigator is responsible for attending meetings with the institutional review board. The principal investigator has many responsibilities.

Difficulty: Moderately Challenging

Instructions

1. To work as a principal investigator you first need to obtain a medical license. The amount of clinical trials may vary depending on what field you are in. For example, there are many rheumatology studies available and many oncology studies available.

2. Next, complete the national institute of health (NIH) clinical research training. A principal investigator should have a formidable knowledge in how clinical trials are conducted.

3. Write a Curriculum Vitae (CV). A CV summarizes the scope of your education, academic work and work history, much like a resume.

4. Attend investigator meetings. Investigator meetings are meetings held by the sponsor or contract research organization to ensure that questions and details get clarified, usually before you start accruing patients into the study.

5. Attend meetings with the institutional review board (IRB). The IRB reviews research projects for an institution to protect the rights and welfare of study participants. Attend Research meetings. Research meetings maybe held to review the Investigator Brochure, Informed Consent, and budget for a clinical trial. Research meetings may also be held with research staff to review how well the study is going, how many participants have been accrued, and study goals. Attend initiation site visits. Initiation visits are not always performed, however sometimes a sponsor of a study requests the principal investigator to attend this visits. The initiation visit is a meeting organized with the study team to review the study components and ensure the institution can meet the requirements of the protocol. The sponsor of a study is the organization that provides the support for the study.

6. Attend monitor visits. The monitor is a clinical research associate who works for the sponsor or a contract research organization (CRO) hired by the sponsor. The monitor is often a contracted individual who ensures the study team is following the protocol. The Principal investigator meets with this person on a regular basis, usually about once a month, to make sure the study team is doing everything accurately.

Tips & Warnings

• Most importantly make sure you provide care for your patient. The patient can ALWAYS choose not to participate, even if they are a good candidate. If they do consent to the study it is the responsibility of the PI to ensure they are getting the best care possible.

[fooshenip]

on 9/30/2009 Great article, thanks. I want you to be able to write full time for the rest of your life.

[fooshenip]

on 9/30/2009 Great article, thanks. I want you to be able to write full time for the rest of your life.

[fooshenip]

on 9/30/2009 Great article, thanks. I want you to be able to write full time for the rest of your life.

[tundranut]

on 3/18/2009 Great article, helpful to prospective study participants in that such a person can feel confident that they're still getting the best possible care even though they're participating in a study. 5* and r