OTHER FORMS

Click on a form name in the table below to open the individual form, and save it to your computer to complete.

Submit Forms/Documents Electronically to the PHRC
When you are done completing your form(s), click here to learn how to submit your completed forms electronically (PHS intranet link).

External Adverse Event Report
10/08
UPDATED		 External adverse events are those adverse events experienced by subjects enrolled at sites that are not relying on the PHRC for IRB review. These are typically sponsor safety reports. Investigators must report to the PHRC any adverse event described in a sponsor safety report that is unexpected and related or possibly related to participation in the research. For more information, refer to the PHRC Adverse Event Reporting Policy.
Internal Adverse Event Report
10/08
UPDATED

Internal adverse events are those adverse events experienced by subjects enrolled at sites that are relying on the PHRC for IRB review. Investigators must report to the PHRC any adverse event that is unexpected and related or possibly related to participation in the research. For more information, refer to the PHRC Adverse Event Reporting Policy.

 
Amendment
07/08

Form used to submit changes to an existing, ongoing, approved protocol. An amendment can include changes to study staff (see form below), protocol revisions, enrollment, etc. ALL CHANGES MUST BE APPROVED BY THE IRB PRIOR TO IMPLEMENTATION.

 

Study Staff Amendment Form
08/06

Investigator Financial Disclosure Form
2/08

Form for adding and/or removing study staff.

NOTE: Co-investigators being added by an amendment must complete the Investigator Financial Disclosure Form and submit to the IRB in conjunction with the Study Staff Amendment Form when the research involves ANY of the following: (1) for-profit sponsor or funding source; (2) a marketed drug, device, or other technology, or a drug, device, or other technology in development; or (3) a new technology, software or therapeutic approach.

 
Emergency Use of
Drugs/Devices/Procedures
05/04

Form for reporting the emergency use of an investigational drug, device or procedure in a life-threatening situation. Refer to Emergency Use of Drugs or Biologics.

 
Response to Review
05/05

Form used by an investigator to respond to concerns or questions from the IRB. For responding to Insight/eIRB submissions, refer to the eIRB Response to Review Instructions.

 
Protocol Exception
01/04
Form used to request an exception to a protocol.
Major Protocol Violation Report
01/04

Form to report major protocol violations.

 
Minor Protocol Violation Report
02/04 		Form to report minor protocol violations at the time of continuing review. This form can be used until the continuing review form is updated to include a section for reporting minor violations.