Benefits of integrated clinical trials systems in risk based monitoring
Keywords:Data integration, Risk based monitoring, Clinical trials, Clinical trial systems, CTMS, Leaner integration, Cross functional integration, Data quality, Data coding, Issue management, Risk management, Trends, Patterns, Clinical site, Adap
In the global world of integrated system, most industry recognized system integration is critical for optimal use to generate globally acceptable data, even clinical research industry is going through a paradigm shift from use of traditional system to integrated system to enhance the data availability on real time and supplements faster review and reporting of critical data points. But altogether to achieve 100% system integration, we need to create all compatible system with each other which require less mapping of different databases with reduced low data migration time.
http://www.appliedclinicaltrialsonline.com/ 2020-vision- fulfilling- future- clinical- research. Last Accessed on 08 February 2016.
http://www.ivrsdevelopment.com/ivrs_clinical_trial_management.htm. Last Accessed on 08 Feb 2016.
Risk-Adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products, Medicines and Healthcare Products Regulatory Agency. October 10, 2011.
Guidance for Industry Oversight of Clinical Investigations: A Risk Based Approach to Monitoring (Draft Guidance), U.S. Food & Drug Administration, August 2011. Last Accessed on 08 Feb 2016.
Morrison BW, Cochran CJ, White JG, Harley J, Kleppinger CF, Liu A, et al. Monitoring the Quality of Conduct of Clinical Trials: A Survey of Current Practices. Clinical Trials. 2011;8(3):342-9.
Guidance Webinar Video, Transcript from FDA Webinar Session, October 24, 2012.
Reflection Paper on Risk-Based Quality Management in Clinical Trials, European Medicines Agency, Aug. 2011, EMA/INS/GCP/394194/2011. Last Accessed on 08 Feb 2016.
Guidance on risk-proportionate approaches to the management and monitoring of clinical trials. Medicines and Healthcare Products Regulatory Agency. October 6, 2011. Last Accessed on 08 Feb 2016.
El Emam K, Jonker E, Sampson M, Krleža-Jerić, K, Neisa A. The Use of Electronic Data Capture Tools in Clinical Trials: Web-Survey of 259 Canadian Trials. Journal of Medical Internet Research. 2009;11(1):e8.
Ferguson, T. e-Patients. http://www.e-patients.net/e-Patients_White_Paper.pdf accessed 29th March, 2011. Last Accessed on 08 Feb 2016.
Greenhalgh T. The Devil’s in the Detail https://www.ucl.ac.uk/news/scriefullreport.pdf. Last Accessed on 08 Feb 2016.
CDC National Center for Health Statistics (2006) more physicians using medical records. http://www.cdc.gov/media/pressrel/a060721.htm?s_cid=mediarel_a060721. Last Accessed on 08 Feb 2016.
Center for Medicare and Medicaid Services (CMS) Fact Sheet (2009) Medicare and Medicaid health information technology: Title IV of the American recovery and reinvestment act. Retrieved 12 August 2009. http://www.cms.hhs.gov/ apps/ media/ fact_sheets.asp last Accessed on 08 Feb 2016.
Certification Commission for Health Information Technology (CCHIT). Retrieved 17 August 2009. http://www.cchit.org/. Last Accessed on 08 Feb 2016.Certification_Commission_for_Healthcare_Information_Technology.
Choi B, Drozdetski S, Hackett M, Lu C, Rottenberg C, Yu L, Hunscher D, Clauw .Usability comparison of three clinical trial management systems. AMIA Annu Symp Proc. 2005:921.