סדנאות בוקר של ביופורום

Data Focus:
Protocol and Data Management
Key Elements in Clinical Trials


  • מספר המקומות מוגבל ולפיכך מותנה באישור צוות ביופורום
  • השתתפות חינם ללקוחות ביופורום ו IMP (מוגבל לנרשם אחד מחברה)

תאריך: 13 פברואר 2017
מיקום הקורס: משרדי ביופורום, גולדה מאיר 3, נס ציונה. קומה 4
מידע כללי
משך הפעילות: יום לימודים מלא
שעות: 09:00-12:00
עלות: 450 ש"ח + מע"מ, חינם - למנויי ביופורום
נקודות זכות: 1
מק''ט: 17829
שפת הקורס: עברית
על הקורס

From the Synopsis to the Full Protocol – Shiri Diskin, Ph.D.
The protocol is the core document of any clinical trial. It sets out the objectives of the study and the methods to be used to achieve them. The protocol is the main tool through which the person responsible for designing the study communicates their intentions to the people responsible for approving the study and the people carrying it out.
Protocols have a uniform format (although not completely rigid), the familiarity with which streamlines the writing process and helps prevent the gaps in information in the final document. Protocols written correctly facilitate clear and rapid communication, shorten approval timelines and help in maintaining the safety of study participants as well as the cleaning of the data collected.
The purpose of the workshop is to familiarize participants with the structure of the protocol, and promoting the process of developing a complete protocol from the core idea embodied in the synopsis

Lifecycle of clinical data - Irina Sher, M.Med.Sc
Clinical data management is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management assures collection, integration and availability of data at appropriate quality and cost. The ultimate goal of Clinical data management  is to assure that data support conclusions drawn from research. Achieving this goal protects public health and confidence in marketed therapeutics. The purpose of the lecture is to familiarize participants with the lifecycle of clinical trial data-starting from targets defined in protocol and until the data submission. 

קהל היעד
  • Investigators who perform clinical studies
  • Research and Development personnel who write protocols
סדנאות בוקר של ביופורום
התועלת שתופק
  • Understanding the various parts of the protocol and the right way to write then so they work together
  • Understanding the importance of templates and the set structure of regulatory documents
  • Knowledge of relevant regulatory guidelines
  • Recognizing the interfaces involved in the writing process of the Protocol and what is required from of each of them
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • What is a clinical study protocol and why do you need it? When does the protocol need to be written?
  • What do you need to start writing?
  • Who reads protocols?
  • Structure of the protocol, the importance of templates and Regulatory authority Guidelines
  • Objectives
  • Background and Rationale
  • Subject Eligibility criteria
  • Study Design
  • Clinical Supplies
  • Safety
  • The Statistical Section
  • Risk and Benefit assessment for Study participants
  • The “smart QC”
אודות המרצה

גב' אירנה שר


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ד"ר שירי דיסקין

Shiri Diskin holds a Ph.D. in molecular biology from Tufts University (Boston, MA), today working as a medical writer, a member of the European Medical Writers Association (EMWA). Shiri has a lot of experience writing, editing and reviewing scientific journal articles, books and regulatory documents in both academic and industry settings. Shiri teaches scientific/medical writing workshops at the Israeli Medical Association and in industry.
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