New Study Submission

The following materials for a new study should be submitted to snthompson@nmhs.net three weeks in advance of the IRB meeting:

 

• Consent form

• New study submission form

• New study submission form (students and residents)

• Electronic copy of protocol

• Electronic copy of Investigator Brochure

• 1572 form (if drug study)

• Staff education plan (if hospital-based study) 

• Research protocol summary (if hospital-based study) 

• Discharge instructions (if hospital-based study) 

• Conflict of interest forms 

• DSMB Charter

• FDA letter indicating the IND or IDE number

• Questionnaires

• Any subject material

The final clean copy of the consent form will be due two weeks prior to the IRB meeting. Studies will be added to the agenda in the order that they are received as long as all of these materials are submitted.

 

 

Resources

 

• Study renewal form
• Study closure form
• Adverse event form
• Protocol deviation form
• Conflict of interest form
• Confidentiality form
• Biomedical consent form