CT: Data Management Systems for Sponsors of Clinical Trials

This course is designed to assist clinical trials sponsors to design data capture methods, and to organize and manage clinical trial data collected from one or more investigative sites. Topics include data flow from site to sponsor; case report form (CRF) design, database structures; database management systems including validation, backup, security and electronic data capture (EDC) systems; data capture techniques, data transfer and uploads; data quality methods including data entry, data review and programmatic checking, CRF-to-database audit procedures; analysis-ready database procedures; patient confidentiality; and ICH Guidelines (21 CFR part 11).

Other Credits: BRN: 16 CE hours.

Course Number: FPM-40218
Credit: 2.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management

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6/29/2024 - 7/20/2024

$525

Live Online

Closed

• SECTION ID:

  182132

• CLASS TYPE:

  Synchronous web-based class meetings that are scheduled to meet online at published times (time/date).

• INSTRUCTOR:

  Rittenhouse, Sharon, Working for a large Contact Research Organization (CRO) and now at a major biotech company

  Sharon Rittenhouse of Allergan Pharmaceuticals, has been involved with clinical trials for over 12 years, starting as a CRC for a small family practice and then moving to a local site management organization (SMO). She made the switch into data management working for a large contact research srganization (CRO) and now at a major biotech company.

• TEXTBOOKS:

  No textbook required.

• POLICIES:

  No refunds after: 6/29/2024.
  

• NOTE:

  Course will be offered via live remote Zoom delivery fo rmat. Zoom class sessions will be held on three Saturdays, June 29, July 13, and July 20, 9: 00 AM to 3 :00 PM (PST).

DATE	DAY	START	END	LOCATION
6/29/2024	Sat	9:00 a.m.	3:00 p.m.
7/13/2024	Sat	9:00 a.m.	3:00 p.m.
7/20/2024	Sat	9:00 a.m.	3:00 p.m.