Rationale
Rationale
Search Engine to Directly Access EHRs without Data Warehouses or Loss of Unstructured Data
Rationale: There is currently an unacceptably long delay in the time required to obtain study approval by the UCSF Committee on Human Research (CHR). The CHR must review and approve all studies involving human subjects performed by UCSF faculty, staff, or students. Studies with more than minimal risk to participants, such as trials of diagnostic tests or treatments, require in-depth review by a faculty-led committee, a process referred to as Full Committee Review. Currently, the average time from submission to approval of these studies is 84 days.
Rationale: US law requires researchers to register clinical trials within 21 days of enrolling the first participant (since 27Sep2007) and to report clinical trial results in the ClinicalTrials.Gov (CT.gov) online system within 12 months of the last participant visit. Reporting results does not mean publishing in a peer reviewed journal, but rather entering information in CT.Gov’s standardized system. Noncompliance can result in the following for institutions and individual PIs: fines of u
NB: This Pilot proposal deals with several completely new ideas and related terminology. To obtain explanations of these new ideas and terminology, please use the inserted Links to jump to WebSites, for descriptive information, and examples.
Rationale: This proposal is based on two premises: First, it is well known that consecutive sampling is preferable to convenience sampling for essentially all prospective enrollment studies. One of the greatest obstacles to implementation of consecutive patient sampling, however, is the need to have 24/7 research assistant (RA) support for patient identification, enrollment, and data collection. Payment for RA support thereby commonly consumes over half of grant budgets for prospective studies, often rendering potentially meaningful studies impractical.