Validating electronic source data clinical trials kimora lee simmons who is she dating

07 Nov

They can include information in original records and certified copies of original records of clinical findings, observations, or other activities captured prior to or during a clinical investigation used for reconstructing and evaluating the investigation.” Saying it differently, e Source data are original subject data that are collected digitally without having to record the data on a piece of paper first, and then transcribe it to an electronic data capture (EDC) system.

It has been shown by many that changes made to the study database as a result of source document verification (SDV) affect neither study results nor the interpretation of those results., it is difficult to explain 1) why many of those managing clinical research operations they still respond to a perceived risk, instead of adopting systematic and scientifically substantiated approaches for data management and cleaning, and 2) why there has been tepid adoption of e Source solutions coupled with “intelligent” monitoring of clinical trials.

Some of us may be curious and adventuresome, while some of us are not; and that is okay.

Some say “if it ain’t broke why fix it” and put off decisions until a crisis hits.

They also serve to provide review and compliance guidance to staff, thereby ensuring that mandates are implemented in a fair, consistent and effective manner.

Investigators like the flexibility and versatility of pen and paper, and they perceive computerized systems as a drain on their productivity.

The Internet is not always easily accessible from the clinical sites, especially overseas.

Perhaps failure to appreciate the wisdom contained in the quotes below explains why those doing clinical research spend a lot of their time on non-productive activities.

There is broad agreement across the pharmaceutical industry that it no longer makes sense to collect clinical trial data by writing results and observations first on a piece of paper, then to transcribe those data into an EDC system, and then to save that paper so that a clinical research associate (CRA) can check how precisely a person transcribed information from a piece of paper into the EDC system.