CASE REPORT FORMS VERSUS ELECTRONIC DATA CAPTURE. Clinical trials traditionally use case report forms (CRFs) to record relevant data in a clinical trial. The medical record (includes laboratory reports, etc) is the primary or source document. Research coordinators copy data from the record to a CRF. The sponsor of the trial then extracts the data from completed CRFs and enters it into the trials data base The data base serves as the “official” data upon which further analyses are performed. Obviously, there are multiple sources for human error when data moves form the medical record to the CRF to the database. Electronic data capture (EDC) permits transfer of the data from the source document to the database. EDC permits verification of data (source data compared with that recorded by EDC) before data is irreversibly entered into the data base), signature (electronic), and security (locking and secure transmission). Most current EDC products use a web interface and permit secure data entry from any Internet-connected computer.
 Investigators designing their own studies should consider the use of EDC as an alternative to designing, printing, and monitoring CRFs. EDC might be particularly useful for large studies and those involving multiple sites. At least one local company, Acumen Healthcare Solutions, has an available EDC product. EDC products are also available from other vendors.
 

EXPLORING CLINICAL RESEARCH OPPORTUNITIES. We encourage faculty who are new to the University of Minnesota or inexperienced in clinical research to consider getting involved. The RSO director or associate director are happy to meet with faculty members to assist them in exploring the possibilities. Experienced clinical investigators should also refer their new or junior colleagues to the RSO and be sure that we add these new people to the newsletter mailing list. RSO contact information can be found at the RSO website (www.ahc.umn.edu/rso/rso_staff.html).
 

CLINICAL RESEARCH COORDINATORS CONFERENCE. The Association of Clinical Research Professionals (ACRP) annual meeting will be held from April 28-May 3, 2001 in San Francisco. Detailed program information and registration forms are available
at www.acrpnet.org.