The title should be easy to remember, recognizable by administrative support staff, and sufficiently different from other protocol titles to avoid confusion. Brevity with specificity and neutrality is the goal. If there is a “short title” (e.g., an abbreviation used to refer to the study title, include here and that can be used throughout this document in place of the full title). Protocol Number: < Number> National Clinical Trial (NCT) Identified Number: <Number, if available> Principal Investigator: < Principal investigator> <IND/IDE> Sponsor: <Sponsor name, if applicable> Sponsor means an individual or pharmaceutical or medical device company, governmental agency, academic institution, private organization, or other organization who takes responsibility for and initiates a clinical investigation. Funded by: < NIH Institute or Center (IC)> Version Number: v.<x.x> <Day Month Year> All versions should have a version number and a date. Use the international date format (day month year) and write out the month (e.g., 23 June 2015). Summary of Changes from Previous Version: Affected Summary of Revisions Made Rationale Section(s)
The title should be easy to remember, recognizable by administrative support staff, and sufficiently different from other protocol titles to avoid confusion. Brevity with specificity and neutrality is the goal. If there is a “short title” (e.g., an abbreviation used to refer to the study title, include here and that can be used throughout this document in place of the full title). Protocol Number: < Number> National Clinical Trial (NCT) Identified Number: <Number, if available> Principal Investigator: < Principal investigator> <IND/IDE> Sponsor: <Sponsor name, if applicable> Sponsor means an individual or pharmaceutical or medical device company, governmental agency, academic institution, private organization, or other organization who takes responsibility for and initiates a clinical investigation. Funded by: < NIH Institute or Center (IC)> Version Number: v.<x.x> <Day Month Year> All versions should have a version number and a date. Use the international date format (day month year) and write out the month (e.g., 23 June 2015). Summary of Changes from Previous Version: Affected Section(s) Summary of Revisions Made Rationale