Oversight & Study Team Members

The Investigator is responsible for selecting study team members who are qualified to carry out study responsibilities in accordance with Principles of ICH GCP and, when applicable, 21CFR312. Your team should consist of the appropriate number of Site Team members who can complete the roles listed below, as needed to serve the purposes of your study:

•    Sub-Investigator

•    Investigational Pharmacist

•    Clinical Research Nurse

•    Clinical Research Coordinator

•    Research Assistant

•    Laboratory Technicians

The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties along with documentation of study team training and qualifications. This documentation should be included in your Regulatory Binder. Training requirements outlined by PSOM can be found in SOP 401, however the Investigator should determine if additional training is required to fulfill assigned roles.

Additional descriptions of the above roles and training resources can be found here. If you would like any support or assistance, please contact OCR Compliance at  psom-ocrcompliance@pobox.upenn.edu.

By far the most important part of being a Sponsor is compiling a qualified trial team that is complimented, as needed, by vendors to fulfill all activities that fulfill the Principles of ICH GCP. Your team should consist of the appropriate number of Sponsor Team members who can complete the roles listed below, this is further explained in the link ACRP Sponsor Key Roles. 

•    Project Manager

•    Clinical Trial Manager (CTM)

•    Medical Writer

•    Pharmacovigilance (including Medical Director and Safety Monitor)

•    Regulatory Affairs

•    Data Management

•    Monitor or Clinical Research Associate (CRA)

•    Statistician

The team and trial operations should be governed by written procedures such as standard operating procedures (SOPs).  The PSOM has Sponsor SOPs for Sponsor Responsibilities, Vendors, Investigational Product, Pharmacovigilance, Monitoring and soon Data Management.  Your Trial Team list as well as documentation of trial team training and qualifications, including Financial Interests, should be documented in your TMF.  Training requirements outlined by PSOM can be found in SOP 401 and SOP 006; however, the Sponsor should determine if additional training is required to fulfill assigned roles.  Sponsor teams may require additional SOPs and should develop trial support systems and tools specific to the team and trial.  Some examples of these tools include documents that should be maintained in your TMF such as an Operations Manual, Communication Plan, Roles and Responsibility Matrix, Transfer of Obligations, and Operational Oversight/Study Decision Log. The Office of Clinical Research is currently working on providing the research community with guides to these documents, these will linked in the near future.

Additional descriptions of the above roles and training resources can be found here. If you would like any support or assistance, please contact OCR Regulatory at PSOM-IND-IDE@pobox.upenn.edu.