Validating electronic source data clinical trials
Source data should be ALCOA and must meet the regulatory requirements for recordkeeping.FDA has proposed that electronically capturing and transmitting source data to the e CRF should: According to the FDA, data can be entered into the e CRF either manually or electronically using “direct entry of data into the e CRF.” For example, there are many data elements in a clinical investigation, such as blood pressure, that can be entered directly into the e CRF at the time of the office visit.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.
Doing the math, moving to electronic systems can provide a dramatic return on investment by 1) reducing labor costs at the clinical research sites and sponsoring companies, 2) reducing travel costs, and 3) providing improvements in data quality.The FDA, in September 2013, issued a final “Guidance for Industry: Electronic Source Data in Clinical Investigations.” Regulators seem ahead of the game in supporting the transformation of how the pharmaceutical industry manages the performance of clinical trials.The following summarizes aspects of the perspectives of FDA and EMA.An acceptable amount of delay should be defined and justified prior to trial recruitment.
The source data and their respective capture methods should be clearly defined prior to trial recruitment (i.e., in the protocol or study-specific source data agreement).
Data element identifiers should be attached to each data element as it is entered or transmitted by the originator into the e CRF.