All About CRADAs and CDA Information

On December 26, 2007, then Under Secretary for Health Michael Kussman, MD, signed the VHA Directive 2007-044 Mandating Use of Cooperative Research and Development Agreements (CRADAs), described at 15 USC §3710a.  Effective March 2008, CRADAs must be used to establish terms and conditions for industry sponsored research studies.  CRADAs are a highly flexible form of federal contract.  They offer sponsors protections for their pre-existing inventions and a means to establish in advance ownership and treatment of any inventions that may result from the collaboration. 

Each CRADA is a three-way contract signed by the industry sponsor, VA and the NPC administering the study.   Because CRADAs must be signed by VA, each CRADA must undergo review and approval by VA.  In order to advance CRADAs through the review and approval process, NPCs should be aware of two departments within VA that are charged with CRADAs negotiations: 

• Technology Transfer Program (TTP) in the Office of Research and Development (ORD) - For comprehensive information about VA CRADAs and CRADAs in general, please go to the VA R&D web site regarding technology transfer: 
  http://www.research.va.gov/programs/tech_transfer/crada/default.cfm
• Specialty Team Advising Research (STAR), program started in September 2012 in the Office of General Counsel (OGC).   
• Click here for Registry of In Process and Executed VA CRADAs

Model CRADAs

To ease the process of negotiating CRADAs with industry sponsors, VA created a variety of model CRADAs for specific research relationships. Following are the types of model CRADAs available:

• Basic Science CRADA Model - For collaborative research, development, engineering, testing or evaluation studies when a VA investigator designs or contributes substantively to the design of the statement of work, and the study does not involve human subjects or materials derived from humans.
• Data Collection CRADA Model - For projects that meet all of the following criteria: a)  the SOW calls for the retrospective or prospective collection of data from patient medical records, such as Registries, data mining and outcomes analysis; b) the SOW does not call for any interaction with patients; c) no intellectual property is anticipated from the project and neither party is interested in pre-commitment of intellectual property rights; and d) the sponsor is not seeking individually identifiable information as defined in the CRADA.
• Device Clinical Trial CRADA Model - For collaborative research, development, engineering, testing or evaluation studies involving devices.
• Phase I-II Clinical Trial CRADA Model - For phase I or II Clinical Trials where the sponsor writes the protocol and holds the investigational new drug (IND)
• Phase III-IV Clinical Trial CRADA Model - For phase II and IV Clinical Trials where the sponsor writes the protocol and holds the investigational new drug (IND)
• Principal Investigator-Initiated CRADA Model - When a VAMC participates in a study of an FDA approved drug or device already on the market, for which a VA investigator designs the protocol and holds any investigational new drug (IND) application.  A commercial company may provide funds, materials and/or equipment.  The study may involve human subjects or materials derived from humans.

• Material Transfer CRADA Model - When any proprietary material and/or information is exchanged between VA and non-VA investigators, when the receiving party intends to use it for his/her own research purposes and when no research collaboration between scientists is planned.  Usually there are no funds made available to support this research and, therefore, NPCs are not a part to Material Transfer CRADAs.

Model CRADAs are updated on a periodic basis and are posted on the VA intranet as they become available.  NPCs are encouraged to check the VA web site to ensure that the latest version is sent to a potential collaborator.  Click here for more information on how to access VA Model CRADAs and guidance.

Types of CRADAs

Before initiating CRADA negotiations, NPCs should inquire whether the sponsor is likely to enlist additional VA sites for the same study or whether the sponsor has already negotiated a Multi-site CRADA or a Master CRADA.

• Single-site CRADA - Used for a specific protocol that will be conducted at only one VA site.
• Multi-site CRADA - A singe CRADA that can be used at multiple VA participating sites for one specific protocol.
• Master CRADA - For those companies regularly conducting studies with VA, a “master CRADA template” is recommended.  These allow a company and VA to pre-negotiate all of the key terms and conditions.  Once a master template is in place, all that has to be added is the protocol and budget.  CRADAs using masters can be completed in just a few weeks.

CRADA Review

NPCs will forward a complete review package to OGC/STAR. A complete review package includes:

• 1) If a CRADA, the document must show all changes made by the Collaborator and NPC against the Model agreement. All documents must be in an editable (i.e. unlocked) MS Word format. If NPCs are forwarding sub-award documents, they should be in an editable (i.e. unlocked) MS Word format;
• 2) A completed CRADA cover page with all information provided;
• 3) Draft Protocol/Statement of Work, and
• 4) A completed, signed, and dated Research Financial Conflict of Interest Statement (OGE Form 450 Alternative-VA 11/2013).

STAR will review documents upon receipt and notify the NPC within 48 hours if the package is complete. If the package is incomplete, STAR will inform the NPC as to what is required to complete the submission. The full review will be completed within 10 federal business days from the receipt by STAR of the complete review package. It is expected that review of a Simple or Master CRADA will be completed in less than 10 business days. During the review, STAR may reach out to program offices such as the Technology Transfer Program, Office of Research and Development, U.S. Trade Representative, and others, for input and guidance. STAR time spent outside of STAR’s jurisdiction does not count against review time. Program offices will provide their review within a reasonable time to OGC.

STAR will review any subsequent revisions to the document within 7 business days from receipt.

Time-line applicable to all Nondisclosure Agreements:

• 1) NPCs or VA will provide to STAR documents in an editable (i.e. unlocked) MS Word format.
• 2) STAR will review and return documents within 6 business days.
• 3) Any subsequent review of documents by STAR will be completed within 3 business days.

See below for a link to more CRADA Review Information provided by the STAR Team.

CRADA Review Documents: This packet contains exact information from the OGC/STAR's SOP for CRADAS as well as, FAQs, and samples to assist in the CRADA process. It is the same information as given from the TTP.

• STAR's SOP - A brief summary of the CRADA Review Process
• NPC Town Hall Questions and Answers
• Sample CRADA Cover Sheet with Complete Information
• Sample Completed COI Form (signed and dated)

eCRADA Registry

NPCs must enter all CRADAs into the online eCRADA registry.  Keeping the information current is a VA requirement.  The registry is an effective means to share information about CRADAs and to avoid duplication of effort.  The registry may be found on the VA intranet by going to: http://vaww.apps.research.va.gov/CRADA.  Requests for log-in or password information or general questions about the registry can be forwarded to Noahline Stuart in TTP (Noahline.Stuart@va.gov).

Legal Review Fee for Research and Education Agreements

Pursuant to 38 U.S.C. §7364, NPCs may reimburse VA's Office of General Counsel (OGC) for any of its expenses in providing legal services attributable to research and education agreements.  OGC initiated a pilot program that is to run from January 2013 through January 2014 and established a standard operating procedure for NPC reimbursement of legal services. 

• OGC Standard Operating Procedure for NPC Reimbursement for Legal Services Attributable to Research and Education Agreements.

CRADA Report

In response to the Technology Transfer Commercialization Act of 2000 (P.L. 106-404), the Office of Management and Budget (OMB) collects from each agency (i.e., VA) information on the total number of active and newly executive CRADAs during the Federal fiscal year. VA collects this information through a report which is sent to each facility's Associate Chief of Staff for Research.  VA's Office of Research and Development (ORD) recently revised the annual CRADA report which includes a question about the number of CRADAs involved with small businesses.  NPCs were asked to use the Department of Commerce definition of small business, which is any business with less than 500 employees.

Helpful tools

• Quick steps on how to re-use CRADAs.
• CRADA FAQs
• CRADA Statutes and Links
• CRADA Fee Schedule
• CDA Presentation