Nick Allan*, Bruce Kriger, Anna Barak (Kirger Research Center Inc.)
* Corresponding author: E-mail: nallan@kriger.ca
Data Management Training Program
I am sure that everyone in the data management community is all too familiar with the 1999 failure of NASA’s Climate observer. Last month marks the 5th anniversary of this spectacular failure of proper data communications and transfer, so I felt that this story makes a timely segue into my discussion on training for a global CDM environment. The NASA investigation which followed the September 23rd crash of the Mars Climate Obiter concluded that two teams involved in the project had each used different measurement units in navigation calculations; one team had used imperial units while the other used the metric system. The data was transferred between the two teams without the necessary conversions.
The result was the loss of a multimillion-dollar spacecraft. While, not necessarily involved with placing a spacecraft in orbit around a planet 303 million miles (487 million kilometers) away, the data handled by the Clinical Data Managers (CDM) is no less important. The success or failure of multimillion-dollar drug trials is often in the hands of the CDM and how critical clinical trial data is handled. More important than advancement of knowledge of a neighboring planet, the data handled by CDMs ultimately affects the health and well being of millions of fellow human beings right here on our own planet.
With the ever expanding globalization of clinical trials and introduction of internet-based clinical trials, the role of the CDM has become increasingly more complex. While the CDM’s primary role is that of a bridge between clinical research and biostatistics, this role has now expanded into serving this function on a global level. This article will endeavor to highlight the goals of global clinical data management and outline the training requirements for clinical data management for the new millennium.
One of the major developments to affect the CDM is the globalization of clinical trials. To address the global needs for international speed-to-market and safety, the International Conference on Harmonisation1 (ICH) was formed in 1990. In November of 2000, the Common Technical Document (CTD) guideline was approved, allowing for simultaneous submission, approval and launch of new drugs in the United States, European Union and Japan. Recently, these ICH countries have released standards for single “folder” submission of new drug approvals to any participating country governed by the standards of the ICH2.
Although a global submission process for approval has been developed, host countries can still enact their own clinical trial security, access and control legislation and policies. Therefore, the global CDM must also be familiar with host country specifics, as well as the standards laid out by the ICH. What’s more, industry-sponsored research has moved rapidly beyond the ICH regions into large parts of Central and Eastern Europe, South America, Asia, and Africa3.This expansion stresses the need for even further standardization and puts an even greater burden on the global CDM to manage non-standardized data in the interim. Global CDM training must accommodate this globalization of clinical trails by providing a standard and cohesive training program to all CDMs on a global basis, to allow for the effective communication and collaboration in these newly expanded clinical research sites.
Another challenge to the global CDM, is the rapid changes and improvements in data management/capture technology. Recently electronic data capture and Internet-based clinical trials (IBCTs) have been introduced and Contract Research Organizations (CROs) and clinical research study sites are progressively moving away from the ‘tried and true’ paper case report forms (CRFs) to this new electronic medium. IBCTs allow for obtaining large sample sizes with reduced unit costs through global access, fast interaction, and automation4. They provide a fast and easy avenue for the acquisition of scientific data, and this method of data acquisition will become much more common place in future multicenter clinical trials5.
The implementation of IBCTs eliminates the need for double-key data entry as the system automatically checks for inconsistent, illogical or missing data6. In IBCTs, most of the data management planning and implementation are completed even before data entry is initiated. The annotated CRF, database design, and the vast majority of edit and logic checks are finalized prior to enrolling the first subject6. The CDM can now look at the data in real-time, and begin the generation of data listings and identification of potential problems early during the course of a study6. Training for CDMs in this new global environment, must accommodate this change in technology and shift in the clinical data management paradigm.
THE GOALS OF GLOBAL CLINICAL DATA MANAGEMENT
- Provide Electronic Translation Solutions: Developing translation software totransform data reliably from a variety of sources into a standard readableformat.
- Develop Data Management Standard Operating Procedures (SOPs): Following Good Clinical Practices (GCP), and GCDMP in a standard way on a global scale.
- Verify Data for Protocol Compliance: Global standards in assessment of allimage and non-image data to ensure proper display format, data integrity andconformance to protocol in accordance with FDA (and/or other) regulations.
- Develop Global Standards in Archiving of Original Data & Back-ups:Provide archive solutions based on the size and type of data setsinvolved in the trial and the sponsor’s needs. Utilization of a secureon-site data storage facility to house electronic backups of all trial datain compliance with GCP disaster recovery requirements.
- Track Patients and Workflows: Training of Research Associates to electronicallymonitor all trial data workflows. Providing the sponsor with access to thisworkflow via a secure link (web interface).
- Provide Sponsor with Electronic Access to Database: Providing sponsors withaccess to trial data via a secure link (web interface).
- Create Database of Data Analysis Results: Extraction of trial data andsubmission of it in sponsor-specific database formats.
- Digital FDA Submission: Digital databases of images, reports, and analysisshould be suited to be submitted electronically (digitally) to the FDA (and/or other regulatory agencies).
- Timely Transfer of Data to Sponsor.
Training for a global CDM environment must encompass all the points laid out in this article. The training must accommodate changes (both technological and industry related) as they arise. To meet the needs of the global demands, can be accommodated through on-line or Internet based methods. To ensure compliance and common training standards are met, this on-line education should be augmented or implemented through some form of accreditation or certification regime through industry organizations like the Society for Clinical Data Management.
The Mars Climate Observer story at the beginning of this article serves as a dramatic example of the potential problems associated with proper data communications and transfer. As clinical research moves into the global arena, and clinical data gathering/transfer technologies shift towards Internet based systems, we should all be cognoscente of the potential ramifications of improper data management and strive towards a future where simple unit errors are only a problem confined to space travel!
References:
- The international Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, (1990).
- Wess, Bernard, P. “Creating a Global IT Infrastructure for Clinical Trials.” Perseid Software Limited, Needham, Massachusetts, (2001).
- Crawley, F.P., Guest Editor. “Good Clinical Practice in a Global Research Setting: Achieving Best Practices in Ethics & Science.” Good Clinical Practice Journal. 6,6 (1999).
- M.A. Kelly and J. Oldham, “The Internet and Randomized Controlled Trials.” International Jounal of Medical Informatics, 47, 91-99 (1997).
- J. Kuchenbecker, H.B. Dick, K. Schmitz et al., “the Use of Internet Technologies for Data Acquisition in Large Clinical Trials.” Telemedicine Journal and e-Health, 73-76 (2001).
- Mitchell, J.T., “Meeting the Challenges of Internet-based Clinical Trials.” Applied Clinical Trials. (2001).
August 15th, 2008 by 
Barry - Admin BioPharmArena
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