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Evolution of the Clinical Data Management Role, 1994-2014

20-Year Retrospective

The role of the Clinical Data Manager (CDM) has changed immensely since 1994, both in terms of role and function. Let's take a fun retrospective look at the great strides made in our field over these last 20 years, and more importantly, where the CDM role is headed. Let's begin with 1994, in honor of the Society of Clinical Data Management (SCDM), which commemorated its 20th Anniversary in 2014.

1994: SCDM Debuts!

In 1994, pop star Justin Bieber was born, Bill Clinton was in the White House, boy bands with obsessively maintained hair were the rage, and shoulder pads donned by women in the 1980s suddenly became very unstylish. The most common way of connecting to the internet was via 28.8K modem. Cell phones were expensive and not widely used. 21 CFR Part 11 did not exist and Y2K was on no one's radar.

Huge desktop computers with chunky monitors consuming more space in depth than width were on everyone's desk. Signs of the times shared by data managers everywhere included:

  • Fat 3-ring binders stuffed full of paper
  • Rows of filing cabinets
  • Stacks of 3-part NCR forms
  • FedEx, UPS and DHL ruled the roadways (kept busy trucking around CRFs and queries)
  • Paper cuts – an everyday health concern
  • Rubber thumb tips – a tool of the trade

There were no common practices surrounding data management – we all simply did it OUR way. Additionally, there were no common data standards supporting trial set up and design.

Clinical monitors and data managers worked in isolation of each other. Paper CRFs were filled out and sent to data management for entry and processing. There was no formal measure of data managers' knowledge and know-how.

Fortunately with the introduction of SCDM, this all begins to change.

1997: CDISC and 21 CFR Part 11 Introduced

The Google domain name was registered (a reminder Google has NOT always been here). "Baby Cha-Cha," a 3D-rendered animation of a dancing baby achieved internet fame, becoming one of the first viral videos. Digital Video Discs, aka Digital Versatile Discs (DVDs), were being mass produced and rapidly overtake VHS. Steve Jobs rejoined Apple.

2000: Good Clinical Data Management Practices Guide Introduced

We welcomed the new millennium and survived Y2K after all. The GCDMP Guide was introduced embodying extensive knowledge of Data Managers. Today the guide continues to assist CDMs with implementation of high quality clinical data management processes. Anyone preparing for CDM training and education finds it a wealth of information.

2002: Certified Clinical Data Manager (CCDM) Program Exam First Offered

The CCDM program established eligibility criteria and standards of knowledge measured by a rigorous examination to qualified applicants. Today it provides instantaneous feedback for organizations seeking to hire the best and brightest in the field.

2014: Mobility!

In the age of all-access computing and communicating everyone carries a smart phone to stay connected! Robotic surgery continues to surge, fashion meets technology with Google Glass, and iPad and convertible laptop sales continue to boom.

In the research world, direct-to-patient trials kick off; big data is everywhere; globalization and outsourcing continue to climb; huge studies are the norm; cost-cutting shows signs of leveling off; analytics rule; and risk-based monitoring is hot.

2015 and Beyond

Here we are entering 2015 and BioClinica is excited about what the future holds. We are working to ensure that our eClinical product roadmap and service delivery model continue to stay ahead of the next round of change in coming years.

Mobility; cloud computing; direct-to-patient trials, risk-based monitoring implementation; and increasingly complex study designs are just a few of the areas where you'll find us working to deliver solutions.

What are some of your favorite memories in data management of yesteryear? Drop me a line and we'll keep the conversation going.

To stay apprised of what BioClinica offers to run better clinical trials, please be sure to visit our website frequently for the latest information. We look forward to working with you in 2015!

Overcoming Barriers to Risk Based Monitoring

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