Conference Description:

Course "Good Clinical Data Management Practices (GCDMP)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:
Why should you attend:
Good clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO).
CDM is involved in all aspects of collecting, processing, and interpreting information. There are many types of computer applications and database systems to support data collection and management. However, there are elements of Good Clinical Practice that apply across the board.
Review and approval of drugs or devices by regulatory agencies requires the assumption that the data presented are valid and reliable. Integrity of the data is paramount to ensure confidence in the results and conclusions you will make.
This seminar is based on FDA E6 GCP Guidelines which are the basis of effective data quality management. Even if your research is not FDA regulated, the information you learn in this course will help to ensure a robust data collection and management plan.
The information conveyed in this course will also assist investigators in setting up processes for smoother data monitoring and auditing.
Examples of CRF’s and required documentation will be presented. Data cleaning techniques will also be demonstrated. Additionally, this workshop will provide you with the knowledge and tools needed to assure GCDMP’s that hold up when the inevitable deviations from protocol occur.

Who will benefit:

• Study Investigators
• Data managers
• Data processors
• Statisticians
• Site Personnel
• Clinical Research Associates
• Clinical Project Managers/Leaders
• Study Sponsors
• Professionals in pharmaceutical, medical device, clinical and biotechnology research who oversee or work with data collection and management
• Staff in the above fields who work with data collection/management and require training in GCDMP.
• Compliance auditors and regulatory professionals who require a knowledge of GCDMP in assessment of study protocols and reports

Agenda:

Day 1 Schedule
Lecture 1 (90 Mins):
GCDMP: The Reasons and The Requirements
• GIGO = Garbage In, Garbage Out. Why we need good practices in data management
• Presentation and overview of FDA GCP Guidelines on data management
• NIH Policy (SOP 15, 17, 19)
• 21 CFR Parts 11, 312.62, 812.140
• Presentation and overview of SCDM guidelines for GCDMP
Lecture 2 (90 Mins):
Elements in Developing a Data Management Plan
• Choosing a vendor and outsourcing
• Data privacy and protection of subject data
• Quality Assurance and Quality Control
• Monitoring and auditing of data
• Errors and Corrections
• Storage and Transfer of Data
Lecture 3 (180 Mins; Afternoon of Day 1):
Study Set-Up
• Essential documents
o Prior to Study Commencement
o During Conduct of the Trial
o After Completion/Termination of the Trial
• CRF design and development (paper/e-CRF)
• Database build and testing
• Edit Checks preparation and testing

Day 2 Schedule

Lecture 1 (90 Mins):
Study Conduct
• Data Entry
• Discrepancies, errors, corrections
• Data Cleaning (preparation) and Coding
Lecture 2 (90 Mins):
Study Conduct (cont’d)
• (MedDRA and WHODDE dictionaires)
• Data Review and Quality Control
• Data Transfer
Lecture 3 (90 Mins):
Study Closeout
SAE Reconciliation
• Quality Control
• Database Lock
• Electronic Archival
• Database Transfer
• Enhancing Reproducibility
Lecture 4 (90 Mins):
Monitoring Visits
• What to expect during a monitoring visit
• Elements for Establishing a Corrective Action Plan
• Question and Answer Session


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