Different Eclinical Tools Used For Clinical Research

By Author: Lydia Daisy
Total Articles: 13
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e-PRO (Electronic Patient Reported Outcome)

What is a patient reported outcome?

A patient reported outcome or PRO, is any report coming directly from patients (i.e., study subjects) about a health condition and its treatment Without the interpretation by the clinician(FDA 2006).

PROs can be generic, condition-specific or treatment-specific; they are used across many therapeutic areas. PROs are available in multiple languages and contain accepted standardized questions collected globally.

Historically, PRO responses were completed by the patient on paper and sent to the clinical data management department for double key entry. This process was lengthy and time consuming, as you can imagine, especially when forms for entry were shipped from thousands of miles away. How do we reduce the time to database lock?

Hence now a day’s ePRO is a patient-reported outcome that is collected by electronic methods. The two main methods currently used for ePRO are computers (Pen Tablet) and telephone / mobile systems.

IVRS (Interactive Voice Response Systems) and IWRS (Interactive Web Response ...
... Systems)

IVRS (Interactive Voice Response Systems) and IWRS (Interactive Web Response Systems) both the tools processes are controlled by a central computer. IVRS is accessed via telephone and IWRS via web interfaces. Both the tools are very useful in Global trials for register new patients, randomize patients, obtain double blind medication, blinding, to unblind patients in Medical emergency etc. Now-a-days most of the protocol uses IXRS (Interactive phone and web Response System) depending on the site convenient their might use the appropriate system.

Fax

Software scans faxed patient forms and faxes back a report, eliminating the need for data entry at the clinic level.

•Limitations
•Confidentiality
•Maintenance and monitoring
•Availability of clerical staff to verify submissions
•Slow turnaround time

Image Recognition Technology

Image-recognition systems, including optical character recognition and optical mark recognition, provide a means of capturing data from printed sources.

Data on paper chart > Scan > OMR/OCR software > EMR

Optical character recognition

Translation of printed text on each page to electronic text documents OCR software converts scanned image to machine-readable and editable text, Less costly and faster compared to manual keying in.

Optical mark reader

Scanning preprinted paper forms to convert marks in checkboxes, text printed in block form and barcodes into machine readable text.

Questionnaire format commonly used in post-marketing trials fast and time saving.

Conclusion

Implementation of eClincal technology in a study helps us in many ways such as real-time data access, clean data at any given point of time, immediate resolution to queries, locking patient data when clean.

Additionally, the LPLV-DBL timelines can be significantly reduced (i.e.) from conventional 8 to 10 weeks for paper studies to three to four weeks for an EDC. These 3 to 4 weeks can further be reduced to a week or even less than that by adopting one of the strategies, such as "Lock as You Go".

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An informative article on the importance of eClinical products/tools written by an employee of MakroCare. MakroCare-DDi gives IT solution to life sciences industries including pharmaceuticals, biotechnology and medical device companies with their eClinical Technologies.