Announcements

Call for Public Comment

• Considerations and business models for using vendor-hosted EDC systems 
• Common practices for training clinical investigational sites in the use of EDC 
• Methods for managing system access and privileges 
• Common steps in system set-up and testing 
• Special considerations for data processing when using web-based EDC 
• Common dynamic workflow and data flow options within web-based EDC systems 
• Basic and common features of fields, forms and form groupings in EDC systems 
• Similarities and differences between paper and web-based data collection 
• The regulatory basis for practices in EDC implementation and study start-up 

The revised edition of this chapter of the GCDMP covers: 
This chapter reviews the implementation and start-up tasks for clinical studies using web-based EDC for form-based data collection and management. Topics covered include designing, developing, testing, and implementing workflow and data flow in clinical studies using EDC systems. Prior to the final publication, we are seeking your input on the draft chapter. 

The 2020 edition of Electronic Data Capture – Implementation and Study Startup is now open for public review and comment.

DOWNLOAD DRAFT CHAPTER

How to submit your feedback: 
• Download a comment sheet. 
• As you read the draft chapter, record your comments in the columns provided. 
• Email your completed comment sheet to [email protected]

COMMENT SHEET

Every comment will be read and resolved by the authors, so this is your opportunity to contribute your expertise to the revision project.

EDC-Implementation and Study Start-up will be open for public comment through March 30, 2020. The authors will host an online presentation to introduce the revisions and speak directly with clinical data managers with questions on Monday, March 2, 2020, at 10 am EST. Keep an eye on your inbox for more information!

REMINDER: The open comment period for Electronic Data Capture – Selecting an EDC System will close on February 10, 2020. 

That leaves you just a few days more to offer your feedback on the 2020 revision prior to publication! You’ll find the draft chapter and comment sheet to download here at the SCDM.org.

#SCDM2020 is officially online!

Visit the website at scdm2020.org to find out everything about the upcoming conference, this year’s tagline?
Explore. Communicate. Pioneer.

#StayTuned and looking forward to welcoming you in San Antonio!

#SCDM

Check Out Our Upcoming Webinars and Online Courses! Key topics include The Triple Constraints, the PM Life Cycle and the Nine Knowledge Areas. 

More info? Click here: https://www.pathlms.com/scdm

#SCDM Community,
Check Out Our Upcoming Webinars and Online Courses! Key topics include The Triple Constraints, the PM Life Cycle and the Nine Knowledge Areas. 

More info? Click here: https://www.pathlms.com/scdm
Last but not least, don’t forget to renew your membership!

Use the online form, and update your profile and info with this link: https://scdm.org/renew-your-membership/

Any questions? Contact us: [email protected]

Bruce Hellman, CEO and Co-Founder of Umotif is the winner of what we know as the People Choice Award. During the Technology Ignite – Spark the Future session at the SCDM 2019 Annual Conference, Bruce showcased his solution for capturing better data for researchers within the world of Clinical Trials and wowed the audience with his innovative approach. If you have missed the session in Baltimore, check out the below podcast to find out more.

#IAMSCDM: The new “GCDMP© – Vendor Selection & Management” is now available.

This new chapter is a consensus-based text including the most current regulatory guidance for data management.
After reading this chapter, you will learn:
• The purpose of and regulatory basis for vendor selection and management
• Differences in outsourcing and contracting models
• Processes for vendor selection
• Contents and organization of vendor scope of work (SOW)
• Processes for vendor oversight
• Governance models for strategic partnerships

Chapter: https://lnkd.in/gxEq3FU

Greetings all participants!  We are in the home stretch with our last week ahead.  There has been some fine discussions and activities and assignments which demonstrate your understanding of the the challenges around the design and use of CRFs.  I appreciate all of your hard work and information sharing.  I do believe that when our organizations can embrace the standards, that are becoming more the norm than the exception, we should be able to become more efficient in our CDM processes.

Welcome to our 2019 CRF Design Course!  I am anxious to "meet" all of you​ as we spend the next 4 weeks dissecting how the importance of well-designed CRFs will be integral in the data collection required for our clinical trials.

Regards,
Denise

Register now for the SCDM EMEA Conference 2019 taking place this 23-25 October 2019 in Berlin, Germany. 

This year's theme will be ‘Evolving Clinical Data Management’, and many of the changes – present & future – are slated to be discussed.

SCDM 2019 EMEA Conference
Berlin, Germany  |  23-25 October 2019
 
Dear Clinical Data Management Friends!

Save the date: this 23-25 October, the Society for Clinical Data Management (SCDM) Europe, Middle East & Africa (EMEA) Conference will take place in Berlin.

Clinical Data Management is typically one of these areas where continuous change has become the new normal. The theme of the meeting will be ‘Evolving Clinical Data Management’, and many of the changes – present & future – are slated to be discussed.
 
As always, the SCDM Conference will be characterized by interaction: the emphasis will be on the exchange of ideas & discussion. The target audience will be the seasoned CDM professionals & leaders, from Pharma, Regulators, CROs & Academia.

More information will be available very soon!