Let’s get back to the basics for a minute. Who are your Study Team members and what is their role?
An individual designated by the research project or activity and funding agency for the proper conduct of the project or activity. May also be known as the Program Director (PD), Project Director (PD), or Clinical Investigator (CI).
In rare but selected instances, it may be necessary for two individuals share the responsibilities of Principal Investigator. In these instances, both individuals will assume the responsibilities defined above, as is appropriate based upon their professional qualifications and licensure.
Sub-Investigator (Co-Principal Investigator)
Individual(s) serving on the study team with the responsibility for the proper conduct of a designated portion of the project but not with the oversight responsibility of a Principal Investigator.
Trained professional who serves under the Principal Investigator to assist with administrative and regulatory aspects of study. Based on licensure, may also be able to assist with clinical activities and procedures.
Company, institution, or organization taking responsibility for initiation, management and financing of study
Clinical Research Organization (CRO)
A service organization that provides support to the pharmaceutical/biotech industry (sponsor company). Services offered by CROs include: product development, formulation and manufacturing; clinical trial management (preclinical through phase IV); clinical, medical and safety monitoring; preclinical, toxicology, and clinical laboratory services for processing trial samples; data management, biostatistics and medical writing services for preparation of an FDA New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA); regulatory affairs support; and many other complementary services
Other Team Members
By delegation of authority from the Principal Investigator, other team members might include physicians, pharmacists, nurses, ancillary health team members and other administrative associates.