NOTE TO FILE Title: IRB #: Principal Investigator: Subject Identifier: Date: Person completing this form: Date Date IRB all that apply or Action Wrong version of consent form signed. The subject did not meet all of the study eligibility requirements inclusion criteria. Protocol deviation. The subject agreed to take part in the study and signed the ICF post study interventions (or participation in the study). Subject non-compliance. CV’s and license, and lab certifications are not in N/A binder, in file cabinet. All contracts and budgets required for a research trial are kept in a central regulatory file in the N/A CCTRO and are maintained by the CCTRO manager. Other Signature: Date:
NOTE TO FILE Title: IRB #: Principal Investigator: Subject Identifier: Date: Person completing this form: all that apply Action Date Date IRB Wrong version of consent form signed. The subject did not meet all of the study eligibility requirements or inclusion criteria. Protocol deviation. The subject agreed to take part in the study and signed the ICF post study interventions (or participation in the study). Subject non-compliance. CV’s and license, and lab certifications are not in binder, in file cabinet. N/A All contracts and budgets required for a research trial are kept in a central regulatory file in the CCTRO and are maintained by the CCTRO manager. N/A Other Signature: Date:
SOP%2012.1%20_Attachment%20A%20Note%20to%20File.docx