The items below are keyed to sections of the eGC-1 form that might cause confusion for investigators who are completing the form for industry-sponsored clinical trials. The items are presented in the order in which they appear in the “Application Details” section of the eGC-1 form.
Under "Application Details"
Title (full): Enter the same title that you used on page 1 of the Human Subjects Application Form under, “Title of Project.”
Dates Requested: For the “Start” date, use the date that you expect to begin incurring expenses related to the trial. For the “End” date, use the last date that you expect to charge expenses to the study budget.
Sponsor deadline: Enter the “Start” data that you entered in 2., above. Industry sponsored clinical trials almost never have firm deadlines; however, the eGC-1 form requires a date for this field.
Under "Budget"
Total Direct Costs and Total Costs: For the initial eGC-1 submission of an industry-sponsored clinical trial requesting concurrent review (CRBB develops the budget while OSP negotiates the contract language), enter "$0" by Total Direct Costs and "$0" by Total Costs. After CRBB completes the budget and sends you their "review summary" email, you will need to withdraw the eGC-1 form in SAGE, insert the agreed-upon dollar amount, and resubmit the eGC-1 form. Note that this resubmission does not require another round of signatures.
Under "Details"
Date needed from OSP: Leave this blank. OSP understands that the contract needs to be negotiated as soon as possible and will proceed accordingly.
Under "Application Type:"
After the Fact Application: Check this box. An industry-sponsored clinical trial is considered to be an after-the-fact application.
Under "Project Details:"
Project Type: Choose “Contract.”
Under "Sponsor:"
Sponsor Name: Choose “Look Up,” then enter the sponsor’s name, exactly as it appears in the research contract, in the “Search for” box. Your sponsor’s name will appear on the screen if the name is in the existing database. If the sponsor’s name does not appear on the screen, follow the directions for adding the name to the database. Note that entering the sponsor’s name correctly, i.e., exactly as it appears in the sponsor’s contract, is very important. Industry sponsors tend to merge and morph, and accurate entries will allow OSP to maintain a current sponsor list.
For industry-sponsored clinical trials, “sponsor” is the company from which the funds originate. Do not list a Contract Research Organization (CRO), whether private or academic, as the sponsor. For example, if Quintiles, Inc. is conducting a study for Pfizer, list Pfizer as the sponsor.
Contact Name and Contact Phone: Provide the name and telephone number of a specific person in the company so that OSP can call that person to discuss contract issues. Note that if a CRO is involved in the study, the contact person is likely to work for the CRO, not the sponsor. Indicate that the contact person is from a CRO by including that information in parentheses after his/her name, e.g., “John Doe (Quintiles).”
Under "Budget:"
For the initial submission of an industry-sponsored clinical trial requesting concurrent review, under the "Total" column, enter "$0" as "unallocated."
For the second submission (after CRBB has completed the budget), enter the total direct costs in the "unallocated" field. You do not need to complete any of the other columns in this section of the eGC-1 form.
Under "Indirect Costs:"
“Amount subject to indirect costs (base): Enter the same amount that you entered in the “Unallocated” sum box, above.
Under "Compliance Questions:"
Financial and General Questions FG-3: “Are indirect costs reimbursed at less than the federally negotiated rate for the UW?” Answer yes.
Under "Compliance Explanations:"
Enter an explanation for any “yes” answer to the compliance questions. For an industry-sponsored clinical trial, you will have answered “yes” at least twice - - once to FG-3 (indirect costs) and once to HS-1 (human subjects). As an explanation for FG-3, enter “25% is the UW industry-sponsored clinical trial indirect cost rate.” The instructions for answering the human subjects questions are self-explanatory.
Signatures:
Note that for industry-sponsored clinical trials, the Department of Medicine requires signature by both the principal investigator’s department chair and division head.