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School of Medicine Office of Research Administration

Route an Agreement for Review

Nondisclosure/Confidentiality Agreement

No COEUS record is required for review of a Confidentiality Disclosure Agreement (also called CDA or Non-Disclosure Agreement or NDA). A MyRAP record will be generated by ORA for these agreements.

For the review of a Confidentiality Disclosure Agreement:

  • Email an editable version of the document, if available, to the ORA Sponsored Project Specialist assigned to your department. If no document is available, ORA has templates for use.
  • If the CDA/NDA anticipates commercially sponsored clinical research, it should be sent to the Pratt St. Office. All others should be sent to MRB.
  • Provide the contact information (name, title, email address, phone #, mailing address, etc.) for the Sponsor; and
  • Identify the purpose and your timeline.
  • A MyRap record will be created for the agreement and you will be contacted upon review.

Materials Transfer Agreement

If an information sheet for the MTA has already been filled out and submitted to JHTV, no COEUS record is required.  Otherwise, a COEUS record should be routed to ORA (Proposal Type= Negotiation Only if no funding)

  • Please provide the following:
    • Editable version of the Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use. If ORA is to draft the agreement, please indicate.
    • Proposed Budget, when applicable. No budget required for unfunded MTA’s.
    • Statement of Work or Scope of Work, clearly describing the materials being transferred and how they are intended to be used.
    • Provide the contact information (name, title, email address, phone #, mailing address, etc.) for the Provider/Recipient
    • IRB/IACUC approval or application number, if applicable (and other applicable compliance, like ISCRO). If these approvals are pending, please indicate.
    • Outgoing transfers of human biospecimens will require approval from the Vice Dean for Clinical Investigation. The form to request this review is available here.

Data Use Agreement

A COEUS record should be routed to ORA (Proposal Type= Negotiation Only if no funding)

  • Please provide the following:
    • Editable version of the Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use. If ORA is to draft the agreement, please indicate.
    • Statement of Work or Scope of Work, clearly describing the data being transferred and how the data are intended to be used.
    • Provide the contact information (name, title, email address, phone #, mailing address, etc.) for the Provider/Recipient
    • IRB/IACUC approval or application number, if applicable (and other applicable compliance, like ISCRO). If these approvals are pending, please indicate.
    • If this request has been approved by the Data Trust, please provide confirmation of the approval. For questions on which transfers require review by the Data Trust, click here

Contract/ Agreement (funded)

A COEUS record should be routed to ORA (Proposal Type= Contract or Subcontract)

COEUS Activity Type must be “Organized Research” as these agreements will be handled by ORA located in the Miller Research Building.

  • For an initial or original agreement:
    • Editable version of the Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use.
    • Provide the contact information (name, title, email address, phone #, mailing address, etc.) for the Sponsor
    • Proposed Budget
    • Statement of Work or Scope of Work
    • IRB/IACUC approval or application number, if applicable (and other applicable compliance, like ISCRO). If these approvals are pending, please indicate.
    • Agreements for commercially sponsored clinical research should be routed with an Activity Type of “Clinical Research” and will be handled at CRC.

Clinical Trial Agreement (commercial sponsor)

COEUS Activity Type must be “Clinical Research” as these agreements will be handled by our Clinical Research Contracting office located at 750 E. Pratt St.

  • For an initial or original agreement:
    • Editable version of the Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use.
    • Supplemental Information Sheet (“SIS”) for Commercial Agreements (available here)
    • Proposed Budget, when applicable. No budget required for unfunded studies.
    • Statement of Work or Scope of Work
    • IRB/IACUC approval or application number, if applicable (and other applicable compliance, like ISCRO). If these approvals are pending, please indicate.

Clinical Trial Agreement (noncommercial sponsor)

COEUS Activity Type must be “Organized Research“as these agreements will be handled by ORA located in the Miller Research Building.

  • For an initial or original agreement:
    • Editable version of the Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use.
    • Provide the contact information for the Sponsor.
    • Proposed Budget, when applicable.
    • Statement of Work or Scope of Work
    • IRB/IACUC approval or application number, if applicable (and other applicable compliance, like ISCRO). If these approvals are pending, please indicate.

Collaboration Agreement (unfunded)

A COEUS record should be routed to ORA (Proposal Type= Negotiation Only if no funding)

  • For an initial or original agreement:
    • Editable version of the Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use.
    • Contact information (name, title, email address, phone #, mailing address, etc.) for Collaborator
    • Statement of Work or Scope of Work
    • IRB/IACUC approval or application number, if applicable (and other applicable compliance, like ISCRO). If these approvals are pending, please indicate.
    • If your collaboration will include the transfer of human biospecimens to an external collaborator, the transfer will need approval by the Vice Dean for Clinical Investigation. The form to request this review is available here »

Grant Award

These agreements/awards must be submitted via the COEUS system with the following documents uploaded: 

(Note:  if a COEUS record for the proposal associated with this award was previously routed to ORA, no additional COEUS record is required)

  • For an initial or original agreement:
    • Editable version of the Award/Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use.
    • Proposed Budget if different from proposal submission.
    • Contact information (name, title, email address, phone #, mailing address, etc.) for Funder
    • Statement of Work or Scope of Work
    • IRB/IACUC approval or application number, if applicable (and other applicable compliance, like ISCRO). If these approvals are pending, please indicate.
    • Proposal COEUS PD# if a COEUS record was submitted at the proposal stage.

Memorandum of Understanding

These agreements must be submitted via the COEUS system with the following documents uploaded:

  • For an initial or original agreement:
    • Editable version of the Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use.
    • Proposed Budget, when applicable. No budget required for unfunded studies.
    • Contact information (name, title, email address, phone #, mailing address, etc.) for Collaborator
    • Statement of Work or Scope of Work or description of the proposed collaboration
    • Some MOU’s will require additional review by the Office of the Provost

Modification to an Existing Agreement

Except for Confidentiality/Non-Disclosure Agreements, a COEUS record is required to formally modify an agreement. COEUS Proposal Type will be Supplement, Continuation, Administrative Action or Negotiation Only depending on the type of modification requested. The process should proceed just like that of a new agreement.

Other Agreements

Most agreements must be submitted to ORA through COEUS.  If you have questions as to whether ORA is the proper office for a particular agreement you can reach out to the ORA Specialist that supports your department for information – click here for commercial clinical research agreements (CRC Office) or here for all other sponsored research agreements (ORA-MRB Office).

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    School of Medicine Office of Research Administration
    East Baltimore Office


    Miller Research Building, Suite 117
    733 N. Broadway, Baltimore, MD 21205

    P: 410-955-3061

     

    School of Medicine Office of Research Administration
    Clinical Research Contracting and
    Clinical Research Support Services

    750 E. Pratt Street, 14th floor
    Baltimore, MD 21202

    P: 410-361-8372

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