If IT'S NOT WRITTEN DOWN - IT DIDN'T HAPPEN! HOW TO APPLY THE GOLDEN RULE OF RESEARCH TO YOUR TRIAL MASTER FILE Good Documentation Practice (GDP) is the cornerstone
If IT’S NOT WRITTEN DOWN – IT DIDN’T HAPPEN! HOW TO APPLY THE GOLDEN RULE OF RESEARCH TO YOUR TRIAL MASTER FILE
Good Documentation Practice (GDP) is the cornerstone to ensuring a quality, inspection ready Trial Master File (TMF). GDP is the responsibility of everyone that contributes (i.e. via submission or creation) clinical trial documentation to the TMF.
This webinar will evaluate the following:
- The regulations that support GDP
- Best practices on how document contributors can apply the golden rule of research to their TMF
- How to avoid writing too many and unnecessary Note-to-Files (NTFs)
- Tips on becoming inspection ready and staying that way
Sholeh Ehdaivand, Principal Consultant and President, LMK Clinical Research
Sholeh is an internationally known TMF Subject Matter Expert with over 15 successful years of experience in the Clinical Research Industry. Her expertise and knowledge in all areas of study management and operational aspects of the clinical trial and document management processes has made her a leader and trusted expert.
Her experience includes the TMF Reference Model Subject Matter Expert, eTMF management, domestic and international pharmaceutical and biological clinical trials, clinical trial management, site selection, vendor relations, electronic document management, regulatory submissions, quality control processes and implementation and regulatory inspection preparation and participation.
Jackie Morrill is a Lean Six Sigma Green Belt certified clinical research professional with nearly a decade of experience in clinical trial coordination and process improvement within the healthcare, biotech, and pharmaceutical industries.
In recent years, her dedicated focus has been on all things Trial Master File (TMF). Her experience includes oversight of electronic TMF (eTMF) implementation, coordination of a large migration project to move 20+ studies from a paper and/or hybrid TMF to an eTMF, development of a robust metrics and training program, a complete overhaul of TMF QC processes, and extensive inspection readiness preparation for FDA, MHRA, and PDMA inspections.
(Thursday) 11:00 am - 1:00 pm
Join LMK's CEO Sholeh Ehdaivand at SoCRA's 26th Annual Conference as she will be speaking on “How to Ensure Trial Master File
Join LMK’s CEO Sholeh Ehdaivand at SoCRA’s 26th Annual Conference as she will be speaking on “How to Ensure Trial Master File (TMF) Quality from Beginning to End” Fri., Oct. 6 at 4:15 to 5:00. EST.
Join over 1,000 of your Colleagues at SoCRA’s 26th Annual Conference! For the 26th year, SOCRA will welcome clinical research professionals from across the world. Located in Orlando FL, at Disney’s Coronado Springs Resort, this three day conference will offer current information and tools, best practices, and training to assure that you’re up-to-date and compliant in your clinical research practice. The program will feature over 100 academic sessions, a peer-driven poster session, and an exhibit program.
All Day (Friday)
Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals. Clinical Research Monitoring is an evolving practice. The purpose of this workshop
Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals. Clinical Research Monitoring is an evolving practice. The purpose of this workshop is to assist Research Site Coordinators, Quality Assurance Auditors, and CRAs/Monitors in improving their skills and their understanding of the roles and responsibilities of the Clinical Research Associate/Monitor. Although designed with all research professionals in mind, this program is ideal for Research Study Coordinators who want to improve the understanding of their responsibilities and interactions with their Clinical Research Monitors, and for Monitors/Auditors/Project Managers with 0-5 years monitoring experience who want to increase their knowledge and understanding of monitoring responsibilities.,.
Objective: The goal will be accomplished through lecture, discussion and practical application facilitated by certified clinical research professionals with combined clinical research experience of more than 20 years. Information will be presented and discussed regarding the conduct of clinical trials; regulatory guidelines regarding IRB oversight and human research protections; ethical issues in clinical research; and workshops will stress the ability to follow directions and practices related to abstracting information and completing case report forms and other records.
Learning Objectives: Upon completion of the workshop, the attendee should be able to:
- Discuss the basic requirements necessary to meet the demands of a CRP in clinical practice
- Discuss the basic components of compliance – Law, regulation, guidance, policy and procedure
- Explain the drug/biologic development process
- Describe the device development process
- Outline concepts for Good Clinical Practice (GCP)
- Explain the elements of informed consent
- Describe the membership and reporting requirements of IRBs
- Explain rules relating to financial disclosure
- Discuss the basics of study design
- Explain the rules and reporting requirements for adverse events and serious adverse events
- Explain study closure procedures and record retention guidelines
- Outline the reasons for monitoring, audits and site visits
- Explain the Food and Drug Administration rules, regulations, and guidelines on research
- Discuss the importance of investigational drug accountability
- Demonstrate and describe how to read clinical reports and records
- Discuss Quality Assurance including, Monitoring and Auditing
- Explain issues that would constitute clinical fraud
October 11 (Wednesday) - 12 (Thursday)
Hampton Inn Philadelphia City Center - Convention Center
1301 Race Street
Proventa International will be gathering over 100 C-Level Directors from a mix of emerging to large Pharmaceutical, Biotechnology & Academic/Research Institutions to help solve their key strategic challenges in the
Proventa International will be gathering over 100 C-Level Directors from a mix of emerging to large Pharmaceutical, Biotechnology & Academic/Research Institutions to help solve their key strategic challenges in the area of Clinical Operations.
(Wednesday) 7:30 am - 9:00 pm
The Westin Boston Waterfront
425 Summer St, Boston, MA 02210 United States