Clinical Trials Administrator Archives – August 1, 2003
August 1, 2003
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Advance preparation is key to keeping clinical trials on track
Clinical trial coordinators can easily become overwhelmed by the myriad tasks they must perform during the studys duration. But the key to keeping a drug or device trial or other research study moving is to do as much advance preparation as possible, say experts. -
Seven tips for managing a clinical trial
The main role of a study coordinator is to act as a patient advocate, yet still maintain the integrity and progress of the trial, says Laurie Czaplewski, RN, BSN, clinical trial coordinator with the Mayo Alliance for Clinical Trials in Rochester, MN. -
Protocols involving prisoners must be approved by OHRP
In an attempt to clarify Department of Health and Human Services (HHS) regulations, the federal Office of Human Research Protections (OHRP) has issued an update to its 2000 guidance on research involving prisoners. -
Tuskegee experiments hold valuable lessons
Most learned people know something about the experiments done on black men in Tuskegee, AL, in the early part of the 20th century: Syphilitic men were enrolled in a study without adequate consent or understanding, and ultimately refused effective treatment in the name of science. -
Trial subjects have emergency help
What would happen if one of your clinical trial participants appeared in an emergency department (ED)? How would physicians know the potential impacts of study medications on their treatment? -
Electronic access gaining momentum
The National Health Information Infrastructure Act of 2003, sponsored by Rep. Nancy Johnson (R-CT), was introduced July 24. The bill would establish architectural standards so that computerized software systems can communicate with each other. -
House BioShield bill excludes incentives
The House version of Project BioShield excludes two elements believed to be key in enticing drug makers into developing biomedical countermeasures.