Standard Forms and Agreements

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Clinical Trial Agreement (CTA)

Clinical Trial Agreements may be used for studies conducted to determine the safety and efficacy of new agents and devices.

• Center for Cancer Research Intramural CTA: Used for clinical trials conducted at the NCI (Word)

Confidential Disclosure Agreement (CDA)

Used for the exchange of confidential information. There are 3 different versions of the CDA. Select from the following:

• For two (2) parties sharing confidential information (Word )
• For an outside party receiving confidential information from NIH (Word )
• For an outside party providing confidential information to NIH (Word )

Cooperative Research and Development Agreement (CRADA)

CRADA is used when NIH and Industry collaborate to further develop a technology for commercialization. There are 3 different versions of the CRADA. Select from the following:

• Standard CRADA: Used for collaborative studies of basic research.
  (Word)
• Intramural Clinical Trial CRADA: Used for collaborative studies which include a clinical trial conducted at the NIH.
  (Word)
• Extramural Clinical Trial CRADA: Used for collaborative studies which include a clinical trial conducted at NIH funded sites.
  (Word)

Employee Invention Report (EIR)

Used by NIH staff for reporting and evaluating inventions. (Word 2007 | Word 2003)

• SAIC-Frederick Invention Report Coversheet This coversheet is for use by SAIC-Frederick staff only - to be completed and attached to an EIR.
  (PDF)

Materials Cooperative Research and Development Agreement (Materials CRADA)

Materials CRADA is a simpler form of CRADA, with no significant collaboration, for the use of a proprietary material in an NIH research project.
( Word)

Material Transfer Agreements

Material Transfer Agreements are used for the exchange of materials with outside organizations for research purposes. The following agreements are preferred by NIH for transferring materials:

Standard Agreements

• Simple Letter of Agreement (SLA) (PDF)
  Intended Materials: vectors, plasmids, compounds, antibodies, peptides Not for Human Subject Research or for samples directly obtained from humans.
• Material Transfer Agreement for the Transfer of Organisms (MTA-TO) (Word)
  Intended Materials: genetically modified organisms, such as mice and other rodents
• Human Materials - Material Transfer Agreement (HM-MTA) (Word)
  Intended Materials: for transfers from the NIH intramural program of materials directly obtained from humans. The HM-MTA is also used for materials that are derivatives of materials originally obtained from humans and that are identified or are coded and NIH has access to the code (MTA policy).
  For NIH Intramural Scientists: A flow chart to help determine the correct MTA to use and required signatories. See also NCI specific flow chart, NIA flow chart, and NIDA flow chart.
• Uniform Biological Material Transfer Agreement (UBMTA) (Word (implementing letter) | PDF (master agreement))
  Intended Materials: vectors, plasmids, compounds, antibodies, peptides, and genetically modified organisms. The UBMTA is intended for sharing of proprietary materials among academic and nonprofit organizations that have signed the UBMTA Master Agreement. Materials can be transferred under the terms of the UBMTA by executing an Implementing Letter. See Signatories for a list of nonprofit organizations that have already signed the Master Agreement.

Other Agreements

While the agreements listed above are preferred, the NCI Technology Transfer Center may utilize other agreements as the situation dictates. Other agreements may include:

• Software Transfer Agreement
• Collaboration Agreement
• Outside party agreements consistent with NIH policies

For more information on any of these agreements, please contact NCI TTC staff.

Natural Products Branch-Developmental Therapeutics Program Memorandum of Understanding (MOU)

The Natural Products Program Memorandum of Understanding is used when a foreign institution provides extracts and /or pure compounds directly to the NCI for antitumor screening and evaluation. (Word)

The Letter of Collection (LOC)

The Letter of Collection is an agreement between the NCI Developmental Therapeutics Program Natural Products Branch and a Source Country (or institution therein) describing the process of collecting samples of the country's biodiversity (plant, marine, microbial) through an approved collection contractor and screening them at the NCI for cancer and other disease targets. (Word)