Opinion: Approaches to Set Up Principal Investigators for Success

Clinical Researcher—June 2018 (Volume 32, Issue 6) PEER REVIEWED Molly Downhour, MHA, BSN, NEA-BC, OCN, CCRC [DOI: 10.14524/CR-18-0002]   Show of hands—how many people believe that principal investigators (PIs) are not currently set up for success? Odds are that not many hands would go up with confidence after that question. As the perception of this […]

Embedding Clinical Research into the Continuum of Care

Clinical Researcher—June 2018 (Volume 32, Issue 6) PEER REVIEWED Jennifer J. Byrne; Jane M. Shen, PharmD; Amanda W. Wright [DOI: 10.14524/CR-18-0004]     Clinical research is the frontline of medical innovation. Through research projects, scientists and physicians make medical breakthroughs that directly impact the lives of patients and their families. However, what many patients and […]

Computer System Validation—A Risk-Based System Lifecycle Approach

Clinical Researcher—June 2018 (Volume 32, Issue 6) ICH IN FOCUS Denise Botto, BS; Michael Rutherford, MS [DOI: 10.14524/CR-18-4033]     In the April 2018 installment of this column (“ICH E6(R2) and Data Integrity: Four Key Principles”), computer system validation (CSV) was briefly discussed as one of the key principles of data integrity. It was emphasized […]

Overcoming Software Challenges at Clinical Trial Investigator Sites

Clinical Researcher—June 2018 (Volume 32, Issue 6) ON THE JOB Rob Innes [DOI: 10.14524/CR-18-4031]   Once a clinical trial has reached the point of patient recruitment, the prime source of data generation and collection becomes the network of investigator sites engaged in the trial. Whether the sites are based at medical clinics, hospitals, or academic […]

The Essential Task of Keeping Technology Clean

Clinical Researcher—June 2018 (Volume 32, Issue 6) DATA-TECH CONNECT Paula Smailes, DNP, RN, CCRC, CCRP [DOI: 10.14524/CR-18-4032]     As our clinical research work environments become dependent on technology, we need to be mindful of the cleanliness of these devices. Technology facilitates research workflows with devices such as laptops, smartphones, tablets, desktop computers, and others […]