Managing the documentation for clinical trials
- 2° EDITION: 27 March 2025
- Online
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Italian
- 1° EDITION: 18 September 2024
- 2° EDITION: 27 March 2025
- Online
-
-
Italiano
-
Training overview
Applications of the new ICH E6 (R3) in step 3
Conducting clinical trials is a complex activity that involves knowledge of specific standardized documentation and involves multiple stakeholders and different organizations. From a documentation point of view, each trial is organized through a series of documents that are the basis of the activities and allow visualizing theoretical and practical aspects, which are useful for all the figures involved in the trial. Different types of studies require “Core Documents”, which are essential for the initial phase of the study. The teacher aims to create a mapping of the study in line with the appendix of the ICH E6 (R3) draft currently in step 3.
Key points of the training
- General concepts and terminology of clinical trial documentation
- ICH steps and ICH timing E6 (R3)
- The Reference Standards of Clinical Trial Documentation
- The possible structuring of the study documentation
- The responsibilities of the figures involved
09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION
- Trial Master File: Core documents and Sponsor/CRO documents.
- Center Study File: documentation specific to each trial center
- Investigator Study File: documentation in charge of the experimental center
- Pharmacy File: documentation from the hospital pharmacy
Q&A Session
Final test (not mandatory)
Clinical Research Sector:
- Quality Assurance, Monitor/CRA, Clinical Trial Assistant and Project Manager
- Study Coordinator and Experimental Center Staff
The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.
For online trainings the access link will be sent 2-3 days before the start of the training.
5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.
Cancellation terms
In order to cancel enrolment to an event, please email in**@ph*******************.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
Participant replacement
It is possible to replace a participant attendance without additional cost, simply by contacting in**@ph*******************.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.
Training cancellation
If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.
Speakers
Oriella Nasta
Quality Assurance & Auditor - Independent Consultant
Graduated in Industrial Pharmacy in 2008 and operating for over 10 years in the pharmaceutical and cosmetic sector with strong experience in clinical studies and skills for the management of CRO pursuant to DM.15.11.2011. In January 2020 she became an Independent Consultant as QA & Auditor with experience in GxP and ISO in the pharmaceutical, cosmetic and food sectors. Expertise: Quality system management (SOP management, selection of training providers; implementation of audits and CAPA), according to GCP/GMP/ISO; Internal and external quality controls, AIFA audits and inspections; Support to CRA, Project Manager and Medical Director for Clinical Trials according to ICH GCP (E6) R2.
Interested in Clinical Research training?
Enroll in 3 courses and you’ll get a 15% discount*, while choosing 5 courses will grant you a 20% discount*!
Choose among these titles:
- Auditing per Clinical Trials: Introduzione Auditing per Studi Clinici
- Auditing per Clinical Trials: Approfondimento Auditing Cycle
- La Documentazione della Sperimentazione Clinica
- Gli Studi Osservazionali
- La Farmacovigilanza negli Studi Clinici
- L’Investigator nella Ricerca Clinica
- CTIS: Guida all’Utilizzo del Nuovo Portale Europeo
(*) discounts apply to the full prices of the courses and cannot be combined with other promotions.
The promotion is limited to enrolling the same person in 3 or 5 courses selected from those offered.
Register now
550€
Training materials available for attendees
Certificate of attendance
Senior trainers with hands-on experience
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