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Basic course on Regulations and Organization of Clinical Trials (BROK®) UMCG

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Since 2006, all clinical researchers - affiliated with the UMCs - are required to follow the Basic Course on Regulations and Organization of Clinical Trials (BROK®) to obtain the corresponding certificate. This course is an initiative of the eight joint University Medical Centers (UMCs).

Target group

Clinical investigators involved in research involving human subjects.

Program​

The course consists of 3 parts:

  • E-learningmodule + Self-assessment (national)
  • Centre specific sessionl
  • Exam (national)


Costs

Participation costs are:

  • € 400,- for UMCG/ RuG
  • € 600,- for external candidates

Since 1 January 2016 the participation costs are excluding 1 re-examination. The re-examination costs are € 100,-.

Registration

You can register for this course on the website NFU Brok® Academie.

To register, you must first register in the BROK portal of the Dutch Federation of University Medical Centers (NFU). Please note: you must complete the current course before 1 January 2020.

After registration and payment, the national database offers the following four options:​

  • to the study arrangements where all the study material is available
  • to the 'self-assessment'
  • to register for the center-specific session in the UMCG. The following dates are planned (if enough subjects participate): 14 May and 2 July 2019 (8.30-12.30)
  • register for a national exam. You can take the national exam at any UMC, registration closes 7 days before the exam date. Dates in the UMCG are (if enough subjects participate) scheduled for: May 21 and July 10, 2019 (9.00-11.30)

Questions​

Denise Mailly, BROK coördinator: Contact

All questions you have about the e-learning,  can be asked by e-mail: Contact


Re-certification BROK UMCG

The BROK® certificate is valid for 4 years, after this period a  re-registration must take place. You can do this via the online re-registration course of GCP Central. The course meets the requirements set by the NFU BROK Academy.

Target group

Clinical investigators with a BROK certificate that expires soon.

Time investment

It takes approximately 6 hours to finish the e-learning module.

Program​

With this basic module you update your knowledge of medical scientific research and the new legislation. The program is accredited by the “Kwaliteitsregister V&V” and “ KNMG-GAIA” with 6 points. BROK® re-registration certificate and update  in BROK® register (by EMWO).

Admission

To follow this module you must have passed the BROK course and must therefore also be registered in the NFU BROK register. Regulations regarding this are documented in the Opleidings- en examenreglement BROK®.

Please note: your BROK registration will expire after 4 years. The re-certification course only leads to an extension of your BROK registration if your current registration has not expired before you complete the re-registration! If in doubt, contact the UMCG BROK coordinator: Contact

Costs

The standard price of the GCP BROK e-learning module is € 125,-.
For UMCG employees a reduced rate of € 87.50 (€ 105.88 incl. VAT) applies if you have a discount code. You can request the discount code at: Contact

You pay online at registration (iDeal or credit card) and after that you will receive an invoice at the specified email address for your administration.

Registration

Start the course immediately? Please go to www.mygcp.nl and create an account. Activate your myGCP® account via the activation link that you receive by e-mail. After activation, choose "buy license" and select the BROK® re-registration course in the webshop. After successful payment (iDeal) the training modules are ready for you on your training page in myGCP®. You can immediately start the BROK® re-certification course.​