Study Expeditor

Study Expeditor

Study Expeditor

PROTOCOL(# or name) :

INVESTIGATOR EMAIL PHONE

  • Are you a WashingtonUniversityfull-time faculty member? Yes No

CONTACT(for Investigator) EMAIL PHONE

FAX CAMPUS BOX

CHECK NOTIFICATIONS WILL BE SENT TO THE INDIVIDUALS ON OUR MASTER LIST FOR THE DEPARTMENT;

CONTACT MELANIE ROEWE WITH ANY QUESTIONS REGARDING THE LIST (747-5390)

SPONSOR NAME:

CRO (if applicable):

CONTACT (for Sponsor or CRO)

PHONE FAX EMAIL

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IRB Approval: Approved Pending N/A Informed Consent: Enclosed Pending N/A

Who developed the protocol? PI Industry Sponsor Non-industry Sponsor (i.e. other academic site, foundation, etc.)

Both PI and Sponsor (If both, who initiated protocol?)

Type of Study: Inpatient Outpatient Both

Treatment Testing Both Data Collection Only

Phase I Phase II Phase III Phase IV N/A

Single Site Multi-Center If Multi-Center, # of sites: 1-10 11 or More Is Wash U Lead Site?

How many patients do you anticipate enrolling (at WU)?

Device Trial:Yes No If Yes, specify category: A or B Who holds the IDE?

Drug Trial: Yes No If Yes, Who holds the IND# If no IND#, is there IND exemption letter from FDA?

If any procedures conducted at any non-WashU facility, please specify type of procedure, location, and department.

______.

Do you have any other support for this study? ______.

When will /did enrollment start for this Study? ______.

Are any sites currently enrolling? ______.

What is Sponsor’s expected enrollment close date? ______.

AGREEMENT PREFERENCES

  • INTELLECTUAL PROPERTY– Do you anticipate that you will make an independent discovery or invention (other than the Sponsor’s anticipated result) related to the study you are performing, or do you expect to make an improvement to or develop a new use for the Sponsor’s drug or product? (A new use is a use beyond the Sponsor’s existing patent and/or FDA approved treatment with the study drug) Yes No
  • DISCLOSURE – Do you* or any investigator* participating in the study have a financial interest in the sponsor consisting of:

Consulting, Speaking fees, Serving on a BOD or SAB, Honoraria, Personal Gifts,

Licensing agreement or royalty income, Equity interests, including stock, stock options, warrants, partnership or equitable ownership interests, or Other fees/compensation *includes family member(s).

  • ICOI – To your knowledge, does this study involve utilizing a technology developed at Washington University that is currently licensed to a commercial entity? Yes No

If yes, please answer the following: Briefly describe the technology: ; Provide the name of the inventor(s) and their department name ; Provide the name of the commercial entity that is party to the license agreement (if known)

  • BUDGET – University overhead for corporate sponsored clinical studies is now 26% effective July 1, 2006. The Budget should include the appropriate University overhead, any departmental overhead, and IRB fees. (Please note that Department Business Offices require review and approval for your budget prior to submission to Sponsor. Please involve them early to avoid delays.). Please forward documentation of Dept approval of the budget, which is required for CCS files.

Is the budget provided by the Sponsor acceptable to you? Yes No Pending

Is the payment schedule provided by the Sponsor acceptable to you? Yes No Pending

CCS SERVICES

Are you requesting CCS services for this study ( IRB submission / coordinator services/CAM/Recruiting)? YESNO

(If yes, complete Request for CCS Services Form as found on the CCS web site: ccs.wustl.edu)

For more information about CCS services, budgets, or contract terms, visit the web site:

PRINCIPAL INVESTIGATOR’S SIGNATURE: DATE:

FORWARD signed Expeditor and ICA form, a copy of the Agreement, Informed Consent and the Protocol Synopsis (if the Protocol Synopsis is not available,send the Study Rationale / Study Objectives)to the e-mail address:

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Rev. 112015

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