On Dec. 12, 2015 Sangeetha Gandepalli, a Technical Lead in Clinical Data Management at Cytel, will speak before SCDM India. Here is a preview of her talk entitled "Data Standards and My Experience."
Data standards play a key role in improving the efficeincy and quality of health care delivery. Without data standards organizations cannot readily share clinical information and medical care becomes geographically isolated.
Data standards are an agreed upon set of rules that allow information to be shared and processed in a uniform and consistent manner.
Which information from a patient's medical history should be communicated to a physician and how?.
If a patient has a life threatening allergy, who ought to know and when? Should a patient’s gender be documented as m or male?
Rules that answer such questions allow individuals and organisations to share medical information using a standard set of practices, creating more efficient communicatons and preventing errors.
Much of the discussion about clinical data standards centers on information technology systems, in particular the development of software that is written to ensure that standard rules of communication are followed.
Though not a prerequiste for the adoption of standards such an approach provides an efficient environement for their development and proliferation, while also reinforcing their use. The benefit of encoding clinical data standards in software applications is that, once developed and adopted, they can be followed reliably with a low error rate- allowing automation of repetetive processes and consistency across applications.
The challenge, however is agreeing to and coding for every possible rule and exception to handle the enormous complexity and variability of clinical process.
Despite many challenges hope for progress is increasing. Mandates such as hipaa have facilatated the adoption of standards and standards already in use including icd-9 etc.
I have expereinced that data standards will help the logical flow of data collection: all critical variables are at least collected, it avoids the redundant collection of data, and time and event are followed as per the protocol. Free text entry needs to be minimised to increase data standards. Check boxes and radio buttons are helpful when able to apply. Units of measures need to be consistent across crf for easy reporting and analyses.
Data standards are sometimes varied across countries as per the local regulations of the country. Hence a sponsor or equivalent needs to communicate on the local guidelines or train accordingly.
Data transfer specification (dts) is important for the data collection of external data. The specifications need to be very clear and consistent with the data collection points mentioned in the protocol. Validation checks play a vital role in keeping up the data quality and standards. Validation checks need to be implemented for all the vital data points which are collected in multiple panels. Each therapeutic area has specified data standards as per cdisc. Edit checks need to be standardised in the edc system.
Sangeetha will present her talk at SCDM India on December 12, 2015 at 11:20. Other Cytel participants at SCDM India 2015 will include Sangeet Kumar and Anil Golla. Here is a full list of activities.
Implementing Quality in Risk Based Monitoring - a DM Challenge
Sangeet Kumar (speaker)
Data Standards and My Experience
Sangeetha Gandepalli (session leader)