Stanley Medical Research Institute | Quarterly Report Form

Quarterly Report Form

Fields marked with a * are required.

Grant ID *

Approval Date (mm/dd/yyyy)

Primary Investigator First Name *

Last Name *

Report Year *

Quarter *

Title of Project *

Total Sample Size *

Total Patients "consented" since the onset of trial *

Total Patients "randomized" since the onset of trial *

Total Patients "currently active" *

Cumulative number of serious adverse events since the onset of trial *

Cumulative number of drop-outs due to adverse events since the onset of trial

"Serious Adverse Events" reportable to the IRB since the onset of trial

Cumulative number of unexpected findings (positive or negative) since the onset of trial

IRB Approval Date (mm/dd/yyyy)

IRB Expiration Date (mm/dd/yyyy) *

Describe any material changes that have occurred or are anticipated in previously described expenditures

Cumulative number of inventions since the onset of trial

List any income received as the result of the project

Please check yes or no (if yes fill in detailed explanation) if the following applies to investigators or sub-investigators at your site participating in the conduct of this protocol:

1) Does the investigator, the investigator's spouse and dependent children collectively have, at any point since the time the investigator began participating in the Project, an equity (ownership) interest, including stock options, shares, American Depository Receipts, or other shareholder interest, exceeding US$50,000 equivalent in any entity with an interest in the outcome of the Project?

If Yes, Explain

2) Does the investigator, the investigator's spouse and dependent children and any of the investigator's affiliated institutions have, since the time the investigator began participating as an investigator in the Project, collectively received non-Project related payments exceeding the cumulative value of US$25,000 from any person or entity with an interest in the outcome of the Project?

If Yes, Explain

3) Any other financial relationship that could be material to a subject's decision to participate in the study.

If Yes, Explain

Comments/Additional Information/Requests

If you need to request a grant extension or permission to carry over unspent funds, please include the request in this section. Please note that if your IRB approval has expired, any requests and/or payments will not be approved until we have received and reviewed all required documents. Please allow 2-3 months from the deadline date for a complete review/payment approval.

SMRI needs current IRB approval on file. Please send any IRB updates to Jana Bowcut at bowcutj@stanleyresearch.org or by fax at 301-571-0768. Please note that informed consent forms are no longer required.

Quarterly Report Form

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