Stanford University Continuing Review Application APP-3
Research Compliance Office [Renewal]
Protocol ID: Protocol Director Name:
File:APP03003 rev11 12/07 4 of 4 http://humansubjects.stanford.edu/
Stanford University Continuing Review Application APP-3
Research Compliance Office [Renewal]
File:APP03003 rev11 12/07 4 of 4 http://humansubjects.stanford.edu/
Stanford University Continuing Review Application APP-3
Research Compliance Office [Renewal]
· For paper protocols:
- Submit two collated copies of this form to: 1215 Welch Rd., Mod. A, Stanford, CA 94305 [M/C 5401].
- You must respond to all of the following items.
- Indicate “N/A” where not applicable.
1. a. Number of participants entered or specimens obtained or charts reviewed
since the beginning of the study.
b. Number of males and number of females entered since the beginning of the study.
c. Minority status of participants enrolled since the beginning of the study.
d. Number of children (less than 18 years) enrolled since the beginning of the study.
e. Number of other potentially vulnerable subjects (if applicable) enrolled since the beginning
of the study, including prisoners, pregnant women, economically and educationally
disadvantaged, decisionally impaired, and homeless people.
2. a. Number of withdrawals of participants from the research (both participant and investigator
initiated) since the beginning of the study. Provide reasons for the withdrawals.
b. Number of participants lost to follow-up since the beginning of the study.
c. Provide a narrative summary of the adverse events since the last Continuing Review (renewal). Indicate whether adverse events experienced by participants are different from those originally anticipated.
d. Provide a narrative summary (not a list) of the unanticipated problems involving risks
to participants or others that have occurred in the research in the past year.
e. Provide a narrative summary and attach any relevant reports (e.g. Data Monitoring
Committee reports, annual progress reports) received in the past year.
f. Complaints about the research in the past year.
g. Noncompliance: Has there been any agency, institutional, or other inquiry into
noncompliance in the study, or any finding of noncompliance concerning a member
of the research team?...... Yes No
If “yes”, please explain:
3.a. Provide a narrative summary of interim findings from your data in the past year.
b. Provide a narrative summary of recent relevant literature.
c. Provide a narrative summary of other relevant information, especially pertaining to risks
in the past year.
d. Provide a narrative summary of benefits experienced by participants in the past year.
e. Provide an assessment of whether the relationship of risks to potential benefits has changed based on the study results in the past year.
4. Description of remainder of project:
a. Is the study open to enrollment?...... Yes No
b. Is the study permanently closed to the enrollment of new subjects?...... Yes No
c. Have all participants completed all research-related interventions?...... Yes No
If “no” describe what intervention(s) participants are still undergoing:
d. Do you wish to renew this study only for long term follow-up?...... Yes No
(Note: Protocols must be renewed to follow subjects.)
e. Are you only doing data analysis?...... Yes No
Proposed Changes [Questions 5 – 7]
5. Describe all proposed protocol changes. Include:
- changes to procedures,
- personnel changes,
- funding changes,
- any other protocol modifications.
6. Describe all proposed Consent Form changes:
If you are still enrolling subjects, attach the consent form(s) you are using for this study.
Do not submit consent form(s) if the study is closed to enrollment.
Be sure to indicate any proposed changes in the consent form.
Note: Any significant new findings that may relate to the subject’s willingness to continue participation must be included in the consent form.
7. Describe any proposed changes in the use of x-rays or radioactive materials:
Include type, amount, route of administration, and total number of administrations per subject since the protocol was last reviewed.
8. Level of risk: Indicate whether the level of risk to participants has changed:
Increase No Change Decrease
If there has been a change, explain:
9. Is this a GCRC (General Clinical Research Center) study; i.e. was this protocol submitted
to the GCRC when it was new? …………………..…………………………………….…… Yes No
If “yes”, you must submit a copy of this renewal to the GCRC, Administrative Associate: M/C 5251.
10. Is this a Cancer Study? ………………..………………………………………..……………… Yes No
If “yes”, submit an electronic copy of this and all documents included in this application to CCTO;
File:APP03003 rev11 12/07 4 of 4 http://humansubjects.stanford.edu/
Stanford University Continuing Review Application APP-3
Research Compliance Office [Renewal]
.
See Steps for Protocol Submission at http://cancer.stanford.edu/trials/admin/forms.html.
File:APP03003 rev11 12/07 4 of 4 http://humansubjects.stanford.edu/
Stanford University Continuing Review Application APP-3
Research Compliance Office [Renewal]
11. Is this a VA Study? ……………………………………………………………………………. Yes No
If “yes”, have all serious or unexpected adverse events been reported
to the VA Research and Development (R&D) Committee?...... …... N/A Yes No
Potential Conflicting Interest
12. a. Has there been a change in the Conflicting Interest status for this protocol; for anyone who recruits, selects, consents, treats subjects, plans to analyze data, plans to serve as an author on papers originating from this research, or is an *immediate family member of anyone in such a role?...... Yes No
If “yes”, answer the following questions i - v:
Does anyone listed above:
i. Have consulting arrangements, responsibilities or equity holdings in the Sponsoring
company, vendor(s), provider(s) of goods, or subcontractor(s)? ..…...... Yes No
ii. Have any financial relationship with the Sponsoring company, vendor(s),
provider(s) of goods, or subcontractor(s)including the receipt of
honoraria, income, or stock or stock options as payment?...... Yes No
iii. Serve as a member of an advisory board with the Sponsoring company,
vendor(s), provider(s) of goods, or subcontractor(s)?...... Yes No
iv. Receive gift funds from the Sponsoring company, vendor(s), provider(s)
of goods, or subcontractor(s)?...... Yes No
v. Have an ownership or royalty interest in any intellectual property utilized
in this protocol?...... Yes No
b. To your knowledge, does anyone in a supervisory role to the Protocol Director have a conflict of interest related to this study? ...... Yes No
If you answer “yes” to any of the questions above, contact Barbara Flynn @ 723-7226, or
File:APP03003 rev11 12/07 4 of 4 http://humansubjects.stanford.edu/
Stanford University Continuing Review Application APP-3
Research Compliance Office [Renewal]
email . http://www.stanford.edu/dept/DoR/ad_hoc.html
File:APP03003 rev11 12/07 4 of 4 http://humansubjects.stanford.edu/
Stanford University Continuing Review Application APP-3
Research Compliance Office [Renewal]
*Immediate family means a spouse, dependent children as defined by the IRS, or a domestic partner.
If one or more of the above relationships exist, please include a statement in the consent form to disclose this relationship, i.e., a paid consultant, a paid member of the Scientific Advisory Board, has stock or stock options, or receives payment for lectures given on behalf of the sponsor (see sample consent form). The consent form should disclose what institution(s) or companies are involved in the study through funding, cooperative research, or by providing study drugs or equipment (see sample consent form).
c. To your knowledge, does Stanford University have an ownership or royalty interest in any intellectual property utilized in this protocol? ...... Yes No
13. List all items (verbatim) that you want to be reflected in your approval letter (e.g., Amendment,
Investigator’s Brochure, consent form(s), advertisement, etc.) in the box below. Include number and
date when appropriate.
File:APP03003 rev11 12/07 4 of 4 http://humansubjects.stanford.edu/