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Version date:

CHILDREN’S HOSPITAL OAKLANDPROTOCOL SUMMARYFORMAT

Five pages is the maximum length for Sections 1 through 5. Sections 6 through 9 are not included in the five-page limit. Put a version date in the top left corner.

Title:

Principal Investigator:

Co-Investigators:

1.HYPOTHESIS AND SPECIFIC AIMS

A.Hypothesis:

B.Specific Aims:

2.BACKGROUND INFORMATION AND SIGNIFICANCE

3.PROGRESS REPORT/PRELIMINARY STUDIES

4.EXPERIMENTAL DESIGN

A.General Study Design:

B.Patient Selection:

C.Inclusion Criteria:

D.Exclusion Criteria

5.PROCEDURES

6.BIOSTATISTICAL DESIGN AND ANALYSIS

A.Sample size and justification:

B.Data analysis:

C.Data management:

7. HUMAN SUBJECTS INFORMATION

A.Subject population including gender and ethnicity:

B.Sources of research material obtained from individually identifiable living human subjects (specimens, records, data):

Indicate whether material/data will be specifically obtained for research purposes or use will be made of existing specimens, records or data.

C.Recruitment plans:

(including outreach), consent procedures to be followed (including circumstances under which consent will be sought and obtained, who will seek it, nature of information to be provided to prospective subjects, and method of documenting consent).

D.Potential risks:

(physical, psychological, social, legal, other). Assess likelihood and seriousness. Describe alternative treatments/procedures.

E.Procedures minimizing potential risks (including risks to confidentiality):

Assess likely effectiveness. Where appropriate, briefly discuss provisions for ensuring necessary medical/professional intervention in event of adverse effects, and provisions for monitoring data collected to ensure safety of subjects.

F.Risk/Benefit Analysis: Discuss why risks to subjects are reasonable in relation to anticipated benefits to subjects, and to the importance of the knowledge that may reasonably be expected to result.

8. REFERENCES

9.RELATED OTHER SUPPORT

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