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Cooperative Research and Development Agreement
(CRADA)
What is a CRADA?
A CRADA, or Cooperative Research and Development Agreement,
is the federal equivalent of a clinical trial agreement,
sponsored research agreement, or material transfer agreement.
CRADAs are developed when the VA or a VA researcher wishes
to collaborate in research with private industry, nonprofits,
or private organizations. The purpose of the CRADA is
to explain the responsibilities of the parties involved.
These agreements typically contain sections that outline
who will do the research, where and when the research
will be done, payment schedules for funding, and intellectual
property rights, among other things.
If you are a Portland VA Medical Center (PVAMC) researcher
planning a research collaboration, contact Paula
Ousley (paula.ousley@va.gov,
PVAMC x55738) as early as possible in the process. Paula
will initiate the CRADA negotiations with the sponsor.
A CRADA can be developed for any kind of research collaboration:
for basic research, for materials transfer, and for clinical
research, including investigator-initiated research and
Phase I to Phase IV clinical trials.
Clinical Research CRADAs
When a proposed project at the PVAMC involves human subjects,
particular issues must be addressed and must be included
in the CRADA for the project:
- The project must use procedures to protect research
participants
- The project must comply with the protocol and applicable
law
- The CRADA must specify who is responsible for providing
and paying for any medical care for research participants
who sustain a research-related injury
- The CRADA must specify the steps to be followed to
communicate results from a research study to participants
when those results directly affect their safety or medical
care
- The sponsor must promptly report to the PVAMC any
findings that could:
- Affect the safety of study participants
- Affect the willingness of participants to continue
in the study
- Influence the conduct of the study
- Alter the IRB’s approval to continue the
study
- Publication of findings from the study must follow
VA policies and procedures
Further information about VA Cooperative Research and
Development agreements is available from the national
VA Technology Transfer web site.
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