| *SCHOOL OF MEDICINE: CORPORATE-SPONSORED CLINICAL STUDY AGREEMENTS ARE SUBMITTED THROUGH THE CENTER FOR CLINICAL TRIALS – SEE SEPARATE PROCESS Where do I obtain the routing form?
Web-based routing form at https://ord2.umaryland.edu/uom/index.lasso
When should I begin routing? - Route proposals for signature at the same time as IRB submission
- Submit advance copies of routing form, proposals, contracts and company protocols directly to ORD for a pre-review (see below)
- Submit budget to ORD after the study budget has been negotiated
What signatures are required? - PI signature, required
- If required, Division Chief, Center Director, or similar position
- Department Chair
- Dean’s Office
What does ORD require in order to begin review/ negotiation? - Protocol
- Copy of routing form, including
- List of sites where UM PI will see study subjects
- Proposed agreement if provided by Sponsor
- Sponsor contact name, phone/fax numbers, e-mail address
How is the agreement finalized?
- PI will be informed of any significant agreement issues raised by the Sponsor or UM.
- Issues are resolved through negotiation
- ORD will provide a response to the Sponsor or follow up on the Sponsor’s response at least every 10 business days
- ORD will provide the PI with information about the status of negotiations at least every 10 business days
What does ORD require in order to sign the agreement for UM?
- Completed, signed routing form
- Sponsor indemnification letter (if not incorporated in agreement)
- Budget and all appendices
- IRB approval
Who sends the agreement to the Sponsor? - Unless otherwise instructed by PI, ORD will return the agreement to the Sponsor as either fully executed or to await full execution by the Sponsor.
- When the agreement has been fully signed, ORD will provide a copy to the PI
When can I begin enrolling study subjects?
- Study subjects may only be enrolled after the protocol has been approved by the IRB and the agreement has been signed by both UM and the Sponsor
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