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Setting up an NDA for a Clinical Trial

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The process for establishing NDAs or CDAs for clinical trial agreements follows these steps:  

  1. Identifying the Need – A need for an NDA arises when a sponsor, collaborator, or university investigator anticipates sharing confidential information related to a potential clinical trial. This is typically identified at the initial discussion stage.  
  2. Initial Contact – The sponsor or collaborator contacts the University to discuss the potential clinical trial and the requirement for an NDA.   
  3. Drafting the NDA – The sponsor usually provides the initial draft. If the University initiates the NDA, the contract team drafts it using University-approved templates. 
  4. Submission in RAMP – A University administrator uploads the NDA request into RAMP to track the agreement and initiate internal review.   
  5. Contract Review – Both the sponsor’s and the University’s contract teams review the NDA to ensure compliance with institutional policies and regulations. At UW-Madison, this involves RSP (Office of Research and Sponsored Programs) for any agreements that are routed through RAMP.    
  6. Negotiation – If revisions are necessary, both parties negotiate terms until they reach a mutually acceptable agreement. The updated agreement is uploaded to RAMP and routed for final approval and signature from RSP.   
  7. Signing – Authorized representatives from both the sponsor and the University sign the NDA. The executed agreement is uploaded into RAMP for recordkeeping. The agreement remains accessible in RAMP for reference throughout the collaboration.  
  8. Implementation – Once the RAMP record is marked “active,” the University may share confidential information with sponsor as permitted under the NDA.    

  

 

  

 

Non-Disclosure Agreements

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What is a Non-Disclosure Agreement (NDA)?

A Non-Disclosure Agreement (NDA) or Confidentiality Agreement (CDA) is an agreement that protects specific proprietary information.  NDA’s can be either uni- or bidirectional depending on the sharing that is contemplated.  NDA’s are critical when you believe you will be sharing potentially valuable or patentable confidential information with a third party.  Many companies will also require you to sign an NDA to engage in discussions about potential collaborations.  Do not sign an NDA in your personal capacity; only authorized UW signatories can sign NDA’s on behalf of the institution. 

When do you need an NDA or CDA? 

An NDA or a CDA is needed when one party is sharing any proprietary information to another party, whether that information is being shared by a UW investigator with a potential sponsor or by a sponsor with a UW investigator.  

CDAs/NDAs are limited to a specific exchange of confidential information between UW and a collaborator. Any research agreements or other projects that emerge from subsequent discussions should be outlined in a supplemental agreement.  If confidentiality needs to extend through the term of the agreement, a confidentiality section in the supplemental agreement will then control.  

FORMS

Conflicts of Interest

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Conflict of Interest Guidance

No member of the academic staff may engage in an outside activity if it conflicts with his or her public responsibilities to the UW School of Medicine and Public Health.

The UW manages three types of Conflicts of Interest:

  1. Conflicts of Commitment
  2. Research Conflicts of Interest
  3. Financial Conflicts of Interest

A conflict of Commitment may occur when outside professional activities interfere with a UW employee’s ability to fulfill UW expectations, obligations, and responsibilities. These are governed by Policy UW-1075. If an outside activity, whether done as part of your UW appointment or separately, will require more than two days of commitment, it must be preapproved by your supervisor.

KEY POINTS
Update your OAR within 30 days of any to change to your outside activities
Determine if Management Plan is Appropriate
Err on the side of disclosure; conflicts can often be managed.

Continue reading “Conflicts of Interest”

Other Teams You Need to Know

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Radius 

Radius is a medical image processing and analysis laboratory within the UW  Department of Radiology.  Research images often have embedded metadata, which may include identifers.  Radius offers services to de-identify images, and can reduce images to a Limited Data Set, depending on the needs of the research team.  This service has been vetted by the Office of the Honest Broker to meet requirements under The Health Insurance Portability and Accountability Act (HIPAA) of 1996.  Radius can also support labs in reviewing their own de-identification processes to confirm that it removes identifiers as intended. 

To contact Radius for a consultation, please email Radius@rad.wisc.edu 

CRDS 

Clinical Research Data Services (CRDS) is a division within of the SMPH Informatics and Information Technology group in the SMPH Dean’s Office.  CRDS provides data support services for investigators who need to extract a large data sets from the Electronic Health Record for purposes of research.  As part of their informatic services, CRDS helps identify and retrieve key data points from the EHR, can de-identify or remove specific identifiers from data sets to ensure compliance with privacy regulations before sharing the data with the study team or third party. 

To begin this process, please submit a consultation request on the link below https://iit.med.wisc.edu/services/data_source_integration/ 

Office of the Honest Broker 

An Honest Broker is an individual who specializes in maintaining the anonymity of data sets.  UW’s office of the Honest Broker provides a variety of services in support of the research enterprise, such as data analysis, coding data sets, and altering data sets to render them de-identified.  The Honest Broker works closely with the CRDS.  Reach out to Ingacio (Nacho) Rodriguez Cortez for assistance.

Cybersecurity 

The SMPH Cybersecurity Team is available to assist you with the technology reviews related to software and data transfers, and can offer assistance when planning complex data transfers related to your research.  They are experts in ensuring that recipients of your data have the security controls in place to ensure that the data is protected in compliance with the applicable regulations.  Contact Amy Diestler for assistance.  

The Dean’s Office Research Administrators

The SMPH Dean’s Office Research Administration team is your principal point of contact for grant submissions and administration.  They are led by Christy Shulz, and maintain a site here.

Additional Links and Resources

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    • https://arrow.wisc.edu 
    • Biosafety officer signature for agreements (if applicable)– Andrea Ladd 
    • https://ehs.wisc.edu/labs-research/biological-safety 
  • Research Animal Resources and Compliance (RARC) – IACUCs ensure that the care and use of animals on campus is ethical and humane by consulting federal regulations, veterinary standards of care, campus policies, and facility standard operating procedures 
  • Purchasing
    • please submit a requisition to Shop@UW+ and include the relevant documents, including any purchasing agreements
    • contact that assigned purchasing agent for support
  • HIPAA – oversight of privacy and security of health information under the Health Insurance Portability and Accountability Act of 1996 
    • Campus HIPAA Security  
  • Export Control – oversight over compliance with US Export Control Laws and regulations 
    • Contact John Jay Miller at John.miller@wisc.edu 
    • Export Controlled activities include: travel abroad, shipping items abroad, working with foreign collaborators, working with controlled items, working under a grant that has an export control clause 
  • UW Health legal issues 
    • Submit Legal Services Request (LSR) and a UW Health attorney will be assigned to the ticket and contact the submitter.  A physician champion is typically required for such requests.