Principal Investigator (2) Insert Name [PI at additional sites, etc. as applicable] Insert Department Insert Address Insert Phone # Insert Email [If applicable] Insert the Name of the Sponsor or Sponsor Investigator Insert Department Name Insert Address Insert Phone Number Email Address Fax Number Include NIH grant number if applicable NIH Grant Number Investigational Product: Insert Investigational Product Name [If applicable] Protocol Number: Insert Protocol Number- As assigned by ACC, sponsor, etc. as applicable [If applicable] Assigned by the IRB. Will not be available at the time of IRB Number: submission. IND/ IDE Number: Insert IND Number or IDE number if applicable. This number will be assigned by the FDA. If not available write pending [If applicable] If applicable Include the National Clinical Trial (NCT) Number assigned once the trial is registered on the ClinicalTrials.gov ClinicalTrials.gov Number website. Initial version [Date] adopt a version control numerical system. Suggest use 0.1, 0.2 for draft versions and 1.0 and 2.0 etc after protocol ahs been finalized. Then stick with numbering convention Amended [Date] Amended [Date] Table of Contents
Principal Investigator (2) [PI at additional sites, etc. as applicable] Insert Name Insert Department Insert Address Insert Phone # Insert Email [If applicable] Insert the Name of the Sponsor or Sponsor Investigator Insert Department Name Insert Address Insert Phone Number Email Address Fax Number NIH Grant Number Include NIH grant number if applicable Investigational Product: [If applicable] Insert Investigational Product Name Protocol Number: [If applicable] IRB Number: Insert Protocol Number- As assigned by ACC, sponsor, etc. as applicable Assigned by the IRB. Will not be available at the time of submission. IND/ IDE Number: [If applicable] Insert IND Number or IDE number if applicable. This number will be assigned by the FDA. If not available write pending ClinicalTrials.gov Number If applicable Include the National Clinical Trial (NCT) Number assigned once the trial is registered on the ClinicalTrials.gov website. Initial version [Date] adopt a version control numerical system. Suggest use 0.1, 0.2 for draft versions and 1.0 and 2.0 etc after protocol ahs been finalized. Then stick with numbering convention Amended [Date] Amended [Date] Table of Contents
ProtocolTemplate_%20ClinicalTrial_final_201502.docx