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In This Section
Other IRB Forms and Templates
This page maintains the few paper forms still required for IRB submissions. For all other forms, the eIRB system contains the required forms needed for submissions.
Form DCC (Data Coordinating Center)
At present, Form DCC and the Change in PI forms that are not integrated into the eIRB application. Form DCC delineates the CHOP PI's responsibilities for one or more aspects of trial oversight for a multi-center clinical research study. Form DCC should be submitted whenever the CHOP PI has one or more responsibilities for the overall conduct of the research (responsible for aspects of overall trial management) for a multi-center clinical research study. Only the aspects that apply to personnel at CHOP need to be completed.
The areas where a PI might have oversight responsibility include:
- site recruitment (identifying and qualifying sites to participate in the research);
- protocol and consent form development (and distribution);
- data management, including case report form development;
- statistical planning and analysis;
- site monitoring;
- safety reporting to regulatory authorities;
- central or research laboratory services; and
- repository storage for future research.
Change in Principal Investigator Form
Investigators and investigative team members can be added to or removed from the listing in eIRB Section 1.02. However, in order for the IRB to process a change in Principal Investigator (PI), the current PI, proposed PI, and the proposed PI's department head or division chief must complete the Change in Principal Investigator Assurance Form. This form allows the proposed PI to attest to the responsibilities that go along with the Principal Investigator role and allows the department head or division chief to confirm that the PI is qualified to conduct the study. Completion of this form is required for transferring the overall responsibility for a study from one PI to another investigator.