University of California Office of the President
Senior Vice President--Business and Finance
Research Administration Office
July 12, 1999
Contract and Grant Officers
C & G CGX System Contacts
Campus Information System CGX Contacts
Subject: Addition of Project Type Categories for Clinical Trial and Material Transfer Agreements in Contracts and Grants Data Base
As follow-up to the discussion at the Contract and Grant Officers’ meeting in Santa Barbara, the Contract and Grant Information Systems Contacts’ meeting in San Diego, and at the recent joint meeting of the Contract and Grant Officers and Patent Coordinators in Irvine, we are proceeding with the plan to establish two new project types in the Corporate Contracts and Grants System (CGX): one for clinical trial agreements, and one for material transfer agreements.
As you know, there is increased emphasis upon getting a complete picture of the University’s relationships with industry. Recommendations from the President’s Retreat on University/Industry Interactions in Research and Technology Transfer, as well as the activities of the President’s Industry-University Cooperative Research Program, emphasize the importance of understanding the breadth and depth of the relationship. While clinical trial activity is currently reported in the CGX data base, there has not been a unique project type category designated for the activity. As such, it has been difficult to assess the portion of the total University-industry interaction attributed to clinical trials. In addition, policy exceptions have been approved for clinical trials, and there are different administrative requirements associated with the activity. Creating a project type category for clinical trials will enhance the utility of the CGX system and provide the means for a better interface with the Corporate Financial System which recently added a unique fund group code for clinical trials.
To date, most material transfer agreements (MTA’s) have not been reported in the CGX system. In recent years, the negotiation and execution of MTA’s has become increasingly important to the University of California research enterprise and activity in this area is often cited as one of the most significant aspects of the University’s relationships with industry. The central tracking of MTA’s will have several advantages. It will serve as a resource for University contract and grant (C&G) negotiators who wish to explore the experience their colleagues have had in negotiating the terms of similar agreements with particular organizations. It also will assist C&G negotiators in determining what intellectual property rights have already been committed for a particular principal investigator before entering into new, potentially overlapping intellectual property commitments. The availability of information on MTA’s in a central location will also enable UC staff responsible for licensing University technology at all UC technology transfer offices to assure that any prior intellectual property commitments made in an MTA have been addressed before the University enters into a license agreement for a particular technology. Finally, collecting basic information on MTA’s is consistent with recommendations put forth in the recent Department of Health and Human Resources (DHHS) draft Principles for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources.
Enclosed is a draft of the change in the CGX data element definition for project type that reflects the changes described above. You will note that the two new categories are specified as an "A" and a "B"; this single character approach allows for the expansion of project type codes beyond '1' through '9' without affecting the record layout of the files sent to the Office of the President (UCOP). As such, it is expected that there will be fewer programming changes required to begin reporting these two new values in the CGX files.
The official change in the reporting specifications will be effective Qtr 3 of FY2000 (due at UCOP on April 21, 2000). While we do not plan to require reporting of these categories until then, we will be prepared to begin receiving the new categories for project type beginning with the First Quarter of FY2000 (due at OP on October 21, 1999). If your local system already captures the project type for clinical trials, you may begin reporting the new categories on the files for the First Quarter of FY2000. Similarly, if information on MTA's is available to you now, you may also begin reporting it as of the same cycle.
Once the new clinical trial and material transfer agreement categories are implemented, the CGX system will be able to report on these projects. Information on clinical trials and MTA's will also be incorporated automatically into the UC/Company Relationships Profiles and Faculty Relationships Profiles currently available as Operational Tools on the OTT Home Page.
Please submit any comments on the proposed changes and data element definition by August 6, 1999.
David F. Mear
Director, Research Administration
Corporate Contract and Grant System Specifications
Name:PROJECT TYPE CODE
Code identifying the award or proposal by the type of research or purpose.
'1' - Basic Research
'2' - Applied Research
'3' - Developmental Research
'A' - Clinical Trial Research
'4' - Other Research
'5' - Training
'6' - Public Service
'7' - Other Service
'8' - Equipment
'B' - Material Transfer
'9' - Other
Comments: See attached for expanded definitions.
Draft: Rev. 09/99
Corporate Contract and Grant Information Requirements
PROJECT TYPE CODE Field Length/Type: 1 alphanumeric
This field identifies the award or proposal by type of purpose. The project type is reported for the total award, not for the individual transaction. For instance, if a modification to a basic research project is made to authorize equipment purchase, the project type remains basic research. All awards and proposals must be identified by one of-the following categories:
Project Type Code
1 - Basic Research
2 - Applied Research
3 - Developmental Research
A – Clinical Trial Research
4 - Other Research
5 - Training
6 - Public Service
7 - Other Service
8 – Equipment
B – Material Transfer
9 - Other
Expanded definitions of categories:
1. Basic Research - that type of research which is directed toward increase of knowledge in science wherein
the primary aim of the investigator is a fuller knowledge or understanding of the subject under study, rather than
a clear or direct practical application thereof. This includes analytical and experimental activities which primarily
seek to increase the understanding of fundamental phenomena. The end product is usually a report, although
experimental hardware may be involved. In basic research, the particular use of the knowledge is not foreseen or
identified at the beginning of the effort.
2. Applied Research - consists of the effort which (1) normally follows basic research, but may not be severable from the related basic research, (2) attempts to determine and expand the potentialities of new scientific discoveries or improvements in technology, materials, processes, methods, devices, and techniques, and (3) attempts to "advance the state of the art". Applied research involves the study of phenomena relating to specific, known needs in connection with the functional characteristics of a system. Applied research does not include any efforts when their principal aim is the design, development, or test of specific articles or services to be offered for sale, which are within the definition of the term development.
3. Developmental Research - means the systematic use and practical application of investigative findings and theories of a scientific or technical nature toward the production of, or improvements in, useful-products to meet specific performance requirements but exclusive of manufacturing and production engineering. The dominant characteristic is that the effort be pointed toward specific problem areas to develop and evaluate the feasibility and practicability of proposed solutions and determine their parameters. Development includes studies, investigations, initial hardware development and ultimately development of hardware, systems, or other means for experimental or operational test.
A. Clinical Trial Research - means the controlled, clinical testing of investigational new drugs, devices, treatments, or diagnostics, or comparisons of approved drugs, devices, treatments, or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions, and/or outcomes, if any, in human subjects. Such studies may be conducted under either a sponsor-developed or an investigator-developed protocol. These studies are conducted in conjunction with obtaining new drug or device approval from the U.S. Food and Drug Administration, under Phase I, II, III, or IV. Preclinical laboratory studies or studies in animals are not included under the term clinical trial research and neither are projects designed to develop new compounds, as well as test them; such projects are reported in one of the other research categories.
4. Other Research - is to be used only if a research project cannot be classified as basic, applied or developmental research.
5. Training (benefiting the University) - for the purposes of reporting to Office of the President, this category means the conduct of scholarly, professional, occupational instruction for matriculated students or University employees in forms such as classes, seminars, workshops, conferences, etc. This category includes sponsorship of students or employees who are "in training" primarily but not exclusively at the graduate and postgraduate levels. The scope of this code also includes sponsored training awards made to The Regents which provide for selection of student recipients by academic departments, and the institutional support which is either included in the training grant or is applied for and awarded separately. Excluded from this group and from this contract and grant information requirement are fellowships or other similar awards made directly from sponsors to students, and Student Aid programs identified in III.A.l.c.
Awards and proposals which require both the development of training materials and the conduct of training as part of the same award should be identified as Training, (Category 5).
Awards and proposals which are primarily for development of training materials and curricula should be identified as Developmental Research, (Category 3).
Training projects which are intended for the training to be conducted by the University for presentation to and for primary benefit to the public, i.e., individuals or groups external to the University, should be identified as Public Service, (Category 6).
6. Public Service - as the term is interpreted in the context of sponsored projects means externally sponsored projects where the sponsor, particularly the Federal and State Government, desire to have the University provide the benefits of scholarly or professional training or services to individuals or sponsor designated recipient groups which are external to the University. Examples of public service may include some programs such as those sponsored by the Agency for International Development, the National Endowment for the Humanities, and the National Institutes of Health in the area of biomedical services or training. The principal characteristic of public service is that individuals and groups external to the University are the. intended beneficiaries.
7. Other Service - includes services which the University provides or makes available which do not fit
within the categories of training or public service, such as the use of University facilities as provided by Regulation
8. Equipment - applications or awards which are restricted by the sponsor for the sole purpose of the University's procurement of equipment. This may include direct grants of equipment, or full or partial funding to enable the University to purchase equipment, where in both cases the sponsor intends to transfer or have title to the equipment vest in the University.
B. Material Transfer - used for agreements whose sole purpose is to govern the transfer of materials to the University from the provider wherein the provider restricts the use of the material to a designated research project. Such agreements often include rights granted back to the provider. Materials may include, but are not limited to, cultures, cell lines, plasmids, nucleotides, proteins, bacteria, transgenic animals, pharmaceuticals, devices, models, reagents or other chemicals. When terms pertaining to the transfer of materials are integrated into an agreement that provides for both the funding of research and the transfer of materials, use the project type appropriate for the financial transaction (e.g. basic research).
9. Other - to be used only if a project can not be classified by one of the above categories.