ORA Announces New Master Clinical Trial Agreements

ORA is pleased to announce that we have recently entered into new Master Clinical Trial Agreements (CTAs) with Millennium Pharmaceuticals, Medarex Inc., and OSI Pharmaceuticals.

Master CTAs are agreements that embody a set of agreed-upon terms and conditions that apply for a sponsor's research projects at JHU. For studies performed under a Master CTA, there is no need to "reinvent the wheel" by negotiating a full set of contract terms for each project, as the sponsor and JHU have already agreed on the "master" set of terms. Instead, each study simply requires a short, simple "work order" or "study letter" that references the Master CTA and sets out the details of the particular study such as the protocol name, principal investigator, schedule details and budget/payment terms.

The use of Master CTAs is a key tool in getting studies up and running at JHU-SOM as quickly and easily as possible. We now have Master CTAs with over 30 commercial sponsors, and ORA anticipates that several new Masters will be completed in the coming months. For the current listing of Master CTAs, please use the following link: http://www.hopkinsmedicine.org/Research/ora/Funding/masteragree.html

Please remember to parallel process your contract and IRB submissions - your department will be reimbursed for commercial study IRB review fee, if a contract is never awarded. Also note that PI-initiated trials may not be covered by all Master CTAs, and that occasionally a sponsor may elect not to use a Master CTA for a given sponsor-initiated trial.

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