September 2025 Update
The University of Utah Clinical Research SOPs have recently been updated!
The following is a summary of recent updates:
- Updated! UUSOP-05: Delegation of Authority has been updated to reflect current practices concerning delegation of authority (DOA) log procedures, specifically removing the requirement for handwriting samples.
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New! UUSOP-07-Supplement A has been created to provide guidance for the creation and implementation of corrective and preventative action plans (CAPAs).
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Updated! UUSOP-09: Case Report Form Completion Standards has been updated to provide clarity on CRF completion standards.
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Updated! UUSOP-11: Investigational New Drug Applications in FDA Regulated Research has been updated to reflect minor grammatical errors.
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Updated! UUSOP-12: Investigational Device Exemption Applications in FDA Regulated Research has been updated to reflect minor grammatical errors.
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Updated! UUSOP-13: Fee Schedule has been updated to reflect the upcoming fiscal year's fees.
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Updated! UUSOP-13 Supplement A has been updated to reflect the upcoming fiscal year's fees.
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Updated! UUSOP-14: Clinical Trial Safety Assessment and Reporting has been updated to indicate that external safety reports from sponsors will not be reviewed unless they are classified as unanticipated problems involving risks to participants or others AND necessitate changes to the conduct of the study.
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New! UUSOP-16: FORM FDA 1572 has been created to provide guidance on the process of completing and updating For FDA 1572 for studies conducted at the University of Utah.
A history of updates to the Clinical Research SOPs is available here.
UUSOP-16: FORM FDA 1572
The new UUSOP-16 was created to describe the process for completing and updating Form FDA 1572 for studies conducted at the University of Utah.
The Statement of Investigator, Form FDA 1572 (1572) is required for all clinical trials in which an Investigational New Drug (IND) application has been filed. The form provides the FDA and sponsors with information about qualifications of an investigator and their clinical site. The form also informs the investigator of their obligations to the research that will be conducted and serves as their signed commitment that they are qualified to conduct the research and will uphold their “Commitments” (see section 9 of the form).
Suggestions for future SOPs are welcome!
Other questions or comments can be submitted through the UofU SOP Contact Us tool, and someone from the Clinical Research SOP Collaboration Team will contact you within 2-3 business days.