PROTOCOL TITLE HERE

( NU IRB Office Version date 4.5.12) (Instructions in italics should be deleted before submission.

Note you may delete any sections that do not apply to your research)

PRINCIPAL INVESTIGATOR: Name

Address

Phone #

Fax #

Email

SUB-INVESTIGATORS:Name(s)

Northwestern University

(List NU sub-investigators first)

PARTICIPATING SITES:Name(s)

Institution(s)

Address

Phone #

Email

(List all sub-investigators for each participation site)

STATISTICIAN: Name

(If Applicable)

FUNDING AGENCY:Name

(If the project is supported financially by a grant or company, please list here. If not applicable, may delete this line)

Synopsis

Title
Short Title
Protocol Date
Study Duration
Study Center(s)
Objectives
Number of Subjects
Diagnosis and Main Inclusion Criteria

Table of Contents

(May be revised and numbered as necessary, but should include major sections)

Synposis......

1.0 Introduction......

2.0 Study Objectives......

3.0 Selection of Subjects......

3.1 Inclusion Criteria......

3.2 Exclusion Criteria......

4.0 Subject Registration......

5.0 Study Design & Methods......

6.0 Statistical Plan......

7.0 Data Collection & Record Keeping......

8.0 References......

Appendices......

1.0Introduction - Background and Rationale(include references)

2.0Objectives

Primary aims of study – listed and numbered individually. Objectives should always be tied to the planned statistical analysis.

3.0Selection of subjects

3.1Inclusion Criteria(should include):

  • Diagnosis required
  • Extent or stage of disease required
  • Prior therapies or medical history
  • Age range
  • If involving actual subjects should include statement about eligibility of

pregnant/lactating females, subjects who are sexually active and/or of childbearing potential

  • All subjects must have given signed, informed consent prior to registration on study.

3.2EXCLUSION CRITERIA

4.0subject Registration

Describe how subjects will be recruited and consented, including where and by whom. If not recruiting actual subjects (i.e. database query for eligible tissue samples), state what will be queried, and how and by whom eligible samples will be identified.

5.0study design & methods

Describe the overall study design, as well as the methods for data collection and data analysis.

6.0statistical plan (May be called “ANALYSIS” if more appropriate)

Must include proposed sample size and justification, as well as a statistical analysis that corresponds directly to the stated aims of the study. If recruitment of subjects is involved, must include a statement of feasibility.

7.0data collection & record keeping

Should include a description of who will perform what tasks, how data will be compiled and stored. Sub-sections might include:

  • Confidentiality Issues
  • Source Documents
  • Case Report Forms
  • Records Retention

9.0References(Begin on separate page)

Appendices

May include data collection forms, detailed specimen processing procedures, patient tools (i.e. questionnaires), etc.

Version Date:

(Each draft should have its own version date for clarity) - 1 -