This course provides an excellent introduction to clinical data management in the pharmaceutical industry. Its focus on processes and their rationale renders it ideal for the new data manager and to other individuals who wish to learn basic clinical data management skills and the function of clinical data management in the medical product development process.
- Understand the medical product and study development process and the regulations that govern the clinical research process
- Identify the roles and responsibilities of the clinical research team
- Discuss the protocol design and development process
- Review the CDM Start-up activities/documentation
- Analyze case report form design, data tracking and collection, data entry and capture
- Discuss data review, validation, and queries
- Comprehend the rationale of the MedDRA dictionary
- Identify the role that CDISC and CDASH play in the standardization of data collection and reporting
- Understand quality control and quality assurance
- Discuss database lock and release
- Understand adverse event reporting and reconciliation
- Identify the changing CDM role towards project management and the issues associated with managing mega-trials and CROs
- Staff of Pharmaceutical Companies, Contract or Independent Research Organizations whose function is to review, correct, enter, or manage data, with less than one year of experience in that function
- Individuals who desire a basic understanding of the function of clinical data management in the medical product development process
The course will be led by one of the following instructors:
Denise G. Redkar-Brown, MT
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Day 1: 8:30 a.m. – 5:00 p.m.
- Introduction to Medical Product Development: Good clinical practice – purpose and history; roles and responsibilities of the FDA/ICH; phases of medical development research and development
- Overview of Clinical Data Management: Data management core processes and data flow; roles and responsibilities within clinical data management; interfaces with other disciplines within clinical research and development
- Protocol and Design: Good clinical study; steps in protocol development; designing a clinical trial; protocol elements and modifications
- Study Start-Up – A Clinical Data Management Perspective: Study documentation; data handling manual; annotated case report form and database design; remote data management
- Case Report Form Design and Development: Standard and study specific case report form modules; organization of a case report form; CRF design guidelines; data collection methods; CRF tracking; data capture, flow and entry; remote data capture
Day 2: 8:30 a.m. – 5:00 p.m.
- Data Review and Validation: Data errors; frequently encountered problems; identifying and developing data checks; data queries
- Coding: Purpose of coding; common coding dictionaries; computerized coding (autoencoding); coding philosophies
- Quality Control and Quality Assurance: Roles of quality control and quality assurance; audits and documentation
- Database Release and Lock: Study close-out and database release; lock and unlock
- Adverse Event (AE) Reporting: Definitions; describing and documenting AEs; collecting AE data
- Core Definitions and Concepts
- To “Split” or Not to Split
- Identifying Data Checks
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-13-034-L01-P. Released: 10/13.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.