Pre-Award Grants and Contracts FAQs

1. Do I have the authority to sign a Confidentiality/Non-Disclosure Agreement (CDA/NDA)?

No. Confidentiality Agreements must be signed by a University Hospitals employee with Authorization Level 7 or above, which includes University Hospitals Cleveland Medical Center’s president. A UH employee that does not have this authorization level, including physicians, does not have the authority to sign on behalf of UH or to bind UH to a contract. It is important to remember that all CDAs/NDAs MUST be reviewed and approved by the Pre-Award office. In addition, the Pre-Award office will obtain the signature for you. Please do not contact UH Cleveland Medical Center’s president or any other authorized official to sign the CDA/NDA.

Please note that a physician/investigator can sign a contract as “Read and Acknowledged.” This does not make a physician/investigator a party to the agreement, it only confirms that he/she understands his/her obligations under the terms of the contract. It is important to note that an authorized UH official will still have to sign the contract even if a physician/investigator signs as “Read and Acknowledged.”

2. Who should sign my contract?

The Pre-Award office can you help you determine who should sign your research contract. Only authorized officials have the authority to sign contracts on behalf of UH. UH Policy GOV-7: Transaction Approval and Authorization determines the signing authority based upon the type of contract and the total amount of the contract. This policy establishes signature authority to protect UH employees from potential liability related to the contractual terms in research agreements.

Please note that a physician/investigator can sign a contract as “Read and Acknowledged.” This does not make a physician/investigator a party to the agreement, it only confirms that he/she understands his/her obligations under the terms of the contract. It is important to note that an authorized UH official will still have to sign the contract even if a physician/investigator signs as “Read and Acknowledged.”

3. Do I need a Data Use Agreement (DUA) to send data outside of UH?

Yes. If the transfer of data is not covered under another agreement, such as a Clinical Trial Agreement, then a Data Use Agreement is required. A DUA is an agreement between a covered entity and a recipient in which the covered entity discloses a Limited Data Set or a De-identified Data Set for purposes of research or any other lawful purpose specified in the contract. Data Use Agreements are required to restrict the use of the shared data, to safeguard the Protected Health Information (PHI) shared (if applicable), and to address issues such as ownership, privacy and publication rights related to the data. For data sets that are classified as Limited Data Sets, a DUA is required by law unless an exception applies. UH policy R-3 addresses Uses and Disclosures of PHI for Research.

There are two types of Data Use Agreements that UH uses to send data outside of the institution.

a) Data Use Agreement for a Limited Data Set (LDS). A Limited Data Set permits limited PHI to be sent to another institution. A total of 16 direct identifiers of a patient need to be removed prior to sending the data. Please refer to UH Policy PH-16: Limited Data Set: Permitted Purposes for Use/Disclosure for specific details regarding the identifiers that need to be removed. A template is available from the Pre-Award office to provide to the recipient of data when UH is the provider.

b) Data Use Agreement for De-identified Data. If you plan on sending de-identified data outside of UH, please ensure that the data is truly de-identified. Please refer to UH Policy PH-15: De-Identifying Protected Health Information (PHI) for additional information on de-identifying data. A template is available from the Pre-Award office to provide to the recipient of data when UH is the provider.

4. Do I need a Data Use Agreement (DUA) if I have a clinical trial agreement, collaboration agreement or subcontract for research purposes?

If you are participating in research that has been approved by the UH Institutional Review Board (IRB) and all subjects are required to sign informed consent forms, which include a valid HIPAA authorization, then you do not need a DUA in addition to your clinical trial agreement, collaboration agreement or subcontract; however, you must have one of these contracts in place if you are conducting research or sharing data with any person or entity outside of UH to ensure that the rights of UH and our patients are protected.

If you are participating in research that has been approved by the UH IRB but has been classified as Non-Human Subjects Research or a HIPAA waiver has been granted, then a DUA or other form of agreement is still required if data is being shared with any person or entity outside of UH.

5. Do I need a Data Use Agreement (DUA) if I am receiving data from an outside organization?

Yes. A DUA includes language that limits the use of the data and also includes ownership, privacy and publication rights related to the data. The organization sending you the data will likely request that their institution’s DUA be used. Please send their DUA to the Pre-Award office and your designated grants and contracts specialist will review the contract to ensure that UH can comply with the terms and conditions.

6. What types of contracts does the Pre-Award office review?
  • Amendment
  • Business Associate Agreement associated with Clinical Research
  • Clinical Trial Agreement
  • Collaboration Agreement
  • Confidentiality/Non-Disclosure Agreement
  • Consulting Agreement
  • Data Use Agreement
  • Grant Agreement
  • Investigator Initiated Clinical Trial Agreement
  • Laboratory Services Agreement
  • Letter of Indemnification (LOI)
  • License Agreement associated with Clinical Research
  • Master Agreement
  • Material Transfer Agreement
  • Service Agreement
  • Study Start-up Agreement
  • Subcontractor/Subsite Agreement

View the definitions of each contract type here.

7. Is there any way to expedite the review of a Clinical Trial Agreement?

Yes. One option is to use a Master Clinical Trial Agreement (MCTA). A Master Clinical Trial Agreement is an agreement that embodies agreed-upon terms and conditions establishing a relationship between UHCMC and a Sponsor. The terms included in the MCTA can govern future research studies between the parties and permits the parties to quickly negotiate future agreements by relying on the terms of the MCTA.

Once a MCTA is in place, a “Work Order” or “Addendum” is generated for each new study to be done under the MCTA. The Work Order sets forth the items particular to a certain study and defines the work activities such as the protocol name, principal investigator, deliverables, timelines, and payment terms. All terms not defined in the Work Order are governed by the MCTA. The use of a MCTA is an excellent resource for getting studies up and running in an efficient manner. UHCMC currently has over 30 MCTAs in place with private/industry Sponsors and the CRC Grant & Contract Specialists are continually reaching out to new Sponsors to assess interest in negotiating these agreements.

Another mechanism to expedite review is through the Accelerated Research Agreements Initiative. The Accelerated Clinical Trial Agreement (ACTA) was developed to create a standard agreement to facilitate relationships and accelerate the contracting process between Sponsors and Institutions. When drafting the ACTA, the entities involved brought to the discussion extensive knowledge from negotiations between private/industry Sponsors and university and academic medical center partners. Based on those negotiations, the language is intended to provide the optimal compromise position for both parties.

The ACTA represents a straightforward and unambiguous position that sets forth regulatory and contractual obligations. The ACTA can be chosen when used in template form with no modifications or when slight modifications are made and approved by UH legal. The use of the ACTA can help streamline and reduce overall contract review time.

While the use of a MCTA or the ACTA is not possible for every new clinical trial at UHCMC, there are additional ways to help expedite your contract review. Each clinical trial agreement is reviewed on a case-by-case basis and there are a number of key issues that are common in all clinical trial agreements. UHCMC focuses on important issues such as subject injury, indemnification, confidentiality, ownership of data and publication rights. In an effort to expedite the contracting process, investigators should discuss these important topics with their Grant & Contract Specialist prior to the start of negotiations.

Even if a MCTA or ACTA is not being used an investigator can help to expedite the review of a Clinical Trial Agreement by providing the following documents to the Pre-Award office prior to the start of negotiations:

  • Draft Clinical Trial Agreement
  • Clinical Trial Protocol
  • Informed Consent Form
  • Completed and signed Startup Forms
  • Status of IRB submission

During clinical trial agreement negotiations, the investigator and study team should proceed with other required start up activities, including submission to the IRB and coverage analysis. In addition, it is important to respond to questions from your Grant & Contract Specialists related to the specific investigator preferences when it comes to subjects such as publication.