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CLINICAL DATA MANAGEMENT - 1. BEST PRACTICES + 2. CDM SOP DEVELOPMENT & IMPLEMENTATION
GOAL: This workshop has been custome-developed and being conducted to impart an internationally accepted standard of knowledge and understanding of the existing global Drug Development and Clinical Research Processes and related regulatory guidelines as well medical/ scientific areas related to Clinical Research
OBJECTIVE: The workshop contains THREE Modules (1 Module / Day) :
a. MODULE I is Regulatory/ Procedural Module consisting sessions pertaining to: 1. Basic of Clinical Data and its importance in the Pharmaceutical and Medical Industry. 2. Roles and responsibilities of stakeholders in the industries. 3. ICH-GCP Guildelines and other local/ international regulatory bodies. 4. Role of regulatory bodies like FDA/ EMEA/ DCGI and the committees like IRB and IEC (from IND to NDA) 5. Source Documentation and modes of generation, storage, retrieval
b. MODULE II consists of sessions pertaining to: 1. Methods of Data Capture (paper-based & electronic), software requirements and types of database, data analysis capabilities and requirements, database staorge, database lock & retrieval.
c. MODULE III consists of basics and in-depth training about SOPs, database management and client management:
TARGET AUDIENCE: Clinical Research Associates, Clinial Data Coordiators/ Executives, Drug Regulatory & Compliance Experts, Principal Investigators, Hospital Sites/ Managers QA/QC Managers :
LEARNING OUTCOMES: The attendees should be able to:
. Discuss the Drug Development Process regarding definitions, regulations and all the processes from IND to NDA (Investigational New Drug - to- New Drug Application)
. Describe the roles and responsibilities of Sponsor/ PI/ Site/ CRC including regulatory, legal and ethical.
. Describe regulations that apply to the Informed Consent Process
. Explain Source Documentation & Research Record Management
. Discuss the Development and Implementation of Standard Operating Procedures throughout processes, across the departments and into all the reporting system
. Learn and understand : Data Ownership, Data Collection, Data Storage, Data Protection, Data Retention, Data Analysis, Data Sharing & Data Reporting
. Describe and discuss importance and benefits of writing and implementing SOPs in Clinical Data Management Project
. Develop workflow and discuss effective writing strategies.
. Develop effective SOP finally by defining and designing policies and intenational standards, and procedures that are agreed upon by data experts internationally
. Discuss examples of successful implementations and implement mechanisms to avoid multiple unsuccessful implementations
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 Ms. Keerti Kamath for questions at: firstname.lastname@example.org and/or
at: 91-9581634185 to discuss your options and take advantage of the savings.
CERTIFICATE OF PARTICIPATION & APPRECIATION PROVIDED UPON COMPLETION OF THE WORKSHOP SUCCESSFULLY