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NEXT CRA Course: Sept. 17-18, 2020 NEXT GCP Training: Sept. 29, 2020

CRA Training - Advanced

Training presentation

A Clinical Research Associate (CRA) is the person responsible for ensuring that the clinical trial is conducted following Good Clinical Practice (GCP) protocol and applicable legislation.

The Clinical Research Associate (CRA) Training Program will increase your knowledge and skills required for working and keeping up with the latest developments in the clinical research arena as a fully qualified CRA.

The Module 2, CRA Training – ADVANCED, is dedicated to Clinical Research Associates (CRA), Senior Clinical Research Associates (CRA), Junior Clinical Associates, Clinical Research Assistants (CTA) and other professionals who have already graduated the Entry-Level Module 1 of CRA Training as all other clinical studies specialists (physicians, pharmacists, biologists, biochemists etc.) willing to improve their monitoring skills.

The participants to Module 1 – CRA Training for Entry Level organized by Avantyo, will benefit of 15% discount to Module 2 – CRA Training for Advanced Level.

CRA Training - Advanced

Module 2 - CRA training Advanced

Scope: Understanding scope and execution of monitoring following ICH E6 (R2) §5.18

Date: September 17-18, 2020

Language: Romanian / English, depending on participants

Location: Radisson Blu Hotel, Atlas I Hall; Calea Victoriei 63 - 81, 1st District, Bucharest, 010065

Trainer: DR. CATALINA SARBU - Head of the CRO Association in Romania (ACCSCR), 
Director Clinical Operations Parexel International Romania

Participation Fee: 350 Euro / 1700 Lei (no VAT refund)

Discounts: 5% for over 3 participants and 10% for over 5 participants from the same institution. For assistance please contact us at anca.bejenaru@avantyo.com, 0726 840 456.

Online registration: by September 14, 2020

AGENDA

2 Days

DAY 1 - SEPTEMBER 17, 2020

8:30 –  9:00 REGISTRATION

9:00 – 10:30

  • Virtual Clinical Trials – Basic principles
  • Guidelines for Computerized Systems in Clinical Investigations
  • Electronic Medical Records
  • Electronic Informed Consent
  • Electronic Trial Master File
  • Electronic Investigator File
  • Electronic patient support and data collecting
  • Electronic Data Capture (eCRF)

The concept of Certified Copies

10:30 – 11:00 COFFEE BREAK

11:00 – 13:00

  • Remote monitoring visit
  • Remote SDR / SDV

13:00 – 14:00 LUNCH

14:00 – 15:30

  • Understanding Essential Documents and their management
  • Cross-check of documents (Case scenarios)

15:30 – 16:00 COFFEE BREAK

16:00 – 17:30

  • Monitoring and safeguarding compliance to regulatory requirements, to protocol, manuals, systems.
  • Aspects of patients’ recruitment and retention (strategies on the various sites potential)
  • Safety reporting


DAY 2 - SEPTEMBER 18, 2020

8:30 – 9:00 REGISTRATION

9:00 – 10:30

  • Fraud in Clinical Research
  • Investigators anti-bribery screening

10:30 – 11:00 COFFEE BREAK

11:00 – 13:00

  • Screening and site-selection activities including QV (evaluating the enrolment potential)
  • Essential points of a successful IV (initiation Visit)

13:00 – 14:00 LUNCH

14:00 – 15:30

  • Audit preparation, participation, answers

15:30 – 16:00 COFFEE BREAK

16:00 – 17:00

  • Communication with the site, the colleagues, the sponsor
  • TEST (multiple choices)

Note: due to the interactive nature of the agenda, the timings may change.

Register now!

Check the red button under the participation fee and make your reservation!

Limited seats. Register by 14th of September, 17:00 (EET)!

Not sure how to book? Click here for instructions in Romanian.

***

Certificates of Attendance: after the completion of the course, they will be available to be downloaded from the participants’ accounts on www.avantyo.com.

Attendance only by online reservation. Booking available after registering on this site.

For discounts and assistance please contact us:
info@avantyo.com, anca.bejenaru@avantyo.com, 0726 840 456.


If you would like to be placed on a waiting list for the next course or you need something else, please let us know at info@avantyo.com. Don’t forget to mention your specific education needs in clinical trials.

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Speakers

Dr. Catalina SARBU Head of the CRO Association in Romania (ACCSCR)
Director Clinical Operations Parexel International Romania
  • General Manager Business Administration & Director Clinical Operations at Parexel
  • 2004-GMBA and Director Clinical Operations–PAREXEL International Romania S.R.L.
  • 2000–Director of the Romanian Representative office of PAREXEL Nederland BV
  • General Practitioner –Center of Hematology, Ploiesti, Romania
  • Saint Antoine University, Paris, France - Hematology and Blood Transfusion, 1-year courses
  • University of Medicine and Pharmacy, Bucharest, Romania -Medical Doctor Degree
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