Boston Professional Events List


Good Clinical Data Management Practices (GCDMP)


Date
Nov 08, 2018 - 08:30 AM
Organizer
NY Events List
Venue
Boston
Location
Boston, MA, Boston, MA

Boston,
Massachusetts,
US,
ZIP: 02101
Phone:

Good Clinical Data Management Practices (GCDMP)

 

*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***
REGISTER TODAY!

 

Clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO).

CDM involves 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 CDM 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.

 

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar
 

Examples of CRF’s and required documentation will be presented. Data collection and preparation techniques will also be demonstrated. Additionally, this workshop will provide you with the knowledge and tools needed to assure a CDM plan that holds up when the inevitable deviations from protocol occur.


Learning Objectives:

  • Regulatory guidelines for Clinical Data Management

  • Best practices for data collection

  • Responsibilities of personnel

  • Case report form criteria

  • Maintaining confidentiality of data

  • Data storage and transferability

  • Data preparation and quality assurance for accuracy

  • Data monitoring plan criteria

  • Data systems validation

  • Adverse event reporting and coding criteria

  • What to expect on a monitoring visit

  • Troubleshooting and resolution of deviations from plan

 

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 CDM.

  • Compliance auditors and regulatory professionals who require a knowledge of CDM in assessment of study protocols and reports

 

AGENDA


Day 01(8:30 AM - 4:30 PM)

8:30 - 8:59 Registration Meet & Greet.
9:00 - 10:30 Introductions: Seminar objectives review, expectations and scope.
Session 1: CDM: 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,
10:30 – 10:45 Break
10:45-12:00 Session 2: 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
Handling Errors and Corrections
Storage and Transfer of Data
12:00-1:00 Lunch
1:00-2:30 Session 3: Study Set-Up
Essential documents
Prior to Study Commencement
During Conduct of the Trial
After Completion/Termination of the Trial
2:30 – 2: 45 Break
2:45-4:30 Session 4: Study Set-Up (continued)
CRF design and development (paper/e-CRF)
Database build and testing
Edit Checks preparation and testing

 

Day 02(8:30 AM - 4:30 PM)

9:00 -10:30 Session 1: Study Conduct
Data Entry
External Data integration and reconciliation
Discrepancies, errors, corrections
Data Cleaning (preparation) and Coding
10:30 – 10:45 Break
10:45-12:00 Session 2: Study Conduct (cont’d)
(MedDRA and WHODDE dictionaires)
Severe adverse events (SAE) status reporting
Data Review and Quality Control
Data Transfer procedures
12:00-1:00 Lunch
1:00-2:30 Session 3: Study Closeout
SAE Reconciliation
Quality Control
Database Lock
Electronic Archival
Database Transfer
Enhancing Reproducibility
2:30 – 2: 45 Break
2:45-4:30 Session 4: Monitoring Visits
What to expect during a monitoring visit
Elements for Establishing a Corrective Action Plan
Question and Answer Session


SPEAKER

Elaine Eisenbeisz

Elaine Eisenbeisz
Owner, Omega Statistics

Elaine Eisenbeisz is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers.

Elaine’s love of numbers began in elementary school where she placed in regional and statewide mathematics competitions. She attended University of California, Riverside, as a National Science Foundation scholar, where she earned a B.S. in Statistics with a minor in Quantitative Management, Accounting. Elaine received her Master’s Certification in Applied Statistcs from Texas A&M, and is currently finishing her graduate studies at Rochester Institute of Technology. Elaine is a member in good standing with the American Statistical Association as well as many other professional organizations. She is also a member of the Mensa High IQ Society. Omega Statistics holds an A+ rating with the Better Business Bureau.

Elaine has designed the methodology for numerous studies in the clinical, biotech, and health care fields. She currently is an investigator on approximately 10 proton therapy clinical trials for Proton Collaborative Group, based in Illinois. She also designs and analyzes studies as a contract statistician for nutriceutical and fitness studies with QPS, a CRO based in Delaware. Elaine has also worked as a contract statistician with numerous private researchers and biotech start-ups as well as with larger companies such as Allergan and Rio Tinto Minerals. Not only is Elaine well versed in statistical methodology and analysis, she works well with project teams. Throughout her tenure as a private practice statistician, she has published work with researchers and colleagues in peer-reviewed journals. Please visit the Omega Statistics website at www.OmegaStatistics.com to learn more about Elaine and Omega Statistics.

 

Please contact the event manager Marilyn ([email protected] ) below for:
- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorships

NO REFUNDS ALLOWED ON REGISTRATIONS
Service fees included in this listing.
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