INVESTIGATORS CAN PREVENT DELAYS IN INITIATING CLINICAL TRIALS. We’ve recently experienced “road blocks” to rapid initiation of clinical trials that could easily be prevented. Here’s what you can do to help the study “start up” process move smoothly and efficiently:

1) Make sure you have an updated AREPA/Form 15 available on file with your department. This only takes 5-10 minutes. Your department won’t sign the BA23/PRF until you have an approved AREPA on file. Sponsored Projects (SPA) will not negotiate a contract with the sponsor until they have the BA23/PRF.

AREPA is “A Report of External Professional Activities.” It is the form used by your department to maintain compliance with the University’s conflict of interest policy. This policy states that employees must annually submit a disclosure form to their departments (whether conflicts exist or not). For more information on how to complete or update your AREPA, talk to your department office or go to http://nirvana.ortta.umn.edu/index.html/. For more on the University’s conflict of interest policy, go to http://www.fpd.finop.umn.edu/.

2) Make sure you meet the educational requirements that are part of the University’s program on the “Responsible Conduct of Research” (RCR). If you haven’t met the requirements, SPA is not permitted to execute a contract and you are not permitted to conduct research. To verify your RCR education and dates of training, go to http://nirvana.ospa.umn.edu/rcr/. For more information about the educational requirements go to http://www.research.umn.edu/training/.
 

VA HUMAN RESEARCH PROTECTION ACCREDITATION PROGRAM. The VA has initiated a program to accredit IRBs/human subjects protection programs at each of its research facilities. The accreditation standards can be reviewed at http://www.ncqa.org/Programs/QSG/VAHRPAP/vahrpapfinalstds.pdf. This accreditation model is an example of what might be mandated for all IRBs by OHRP and the FDA in the future.
 

GOOD CLINICAL PRACTICE WEB SITE. The FDA has recently revised its Web site with information on "Good Clinical Practice in FDA-Regulated Clinical Trials" The site provides access to FDA regulations, guidance, compliance programs, FDA contact information relating to clinical trial conduct, and other FDA web sites. The URL for the site is http://www.fda.gov/oc/gcp.