Essential Good Clinical Practice for Investigators Online Training

Essential Good Clinical Practice for Investigators Online Training
Essential Good Clinical Practice for Investigators Online Training
Product Code: Essential Good Clinical Practice for Investigators
Availability: In Stock
Price: £100.00

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PLEASE NOTE: If you are booking for more than one participant or on behalf of someone else within your organisation you will be required to complete an 'Online Course Registration' form which can be downloaded by clicking here. Please ensure you click the 'Send to Brookwood Academy by E-mail' button at the bottom left of the form once completed. Failing to complete the form will cause delays in processing your order

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This short but comprehensive course provides essential information about the principles and practices of good clinical practice based on the ICH GCP guidelines. It focusses on the key responsibilities and offers good practice advice.

View our latest Essential Good Clinical Practice brochure here.

 

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. The training has been awarded 6 CPD credits by the faculty of Pharmaceutical Medicine (Royal Colleges of Physicians of the United Kingdom).

 

The training is available in numerous languages. The English version has been translated and adapted into Latin American Spanish, Brazilian Portuguese, Russian, Simplified Chinese (with Mandarin narration), French, German, Turkish, Italian, Japanese, Serbian, Czech and Polish. Each language version has the narration, notes, user guide, quizzes, exam and log on instructions in the chosen language.

Fantastic rates available for groups of 5 or more participants. Contact us NOW!

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Aims and Objectives

This short but comprehensive course provides essential information about the principles and practices of good clinical practice based on the ICH GCP guidelines. It focusses on the key responsibilities and offers good practice advice. The training will ensure that participants understand the need for GCP compliance by all those who take part in clinical trials. This training has been awarded 6 CPD credits by the Faculty of Pharmaceutical Medicine (Royal Colleges of Physicians of the United Kingdom)

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Who is the course for?

The training programme is suitable for those needing a basic knowledge of GCP, including investigators and other study site staff, sponsor personnel, senior managers, administrators and members of ethics committees. In addition, it can be used as core basic training to set a minimum standard for all staff.

What does it entail?

The programme consists of automatically advancing narrated slides and interactive quizzes followed seamlessly by an online examination for the Certificate in Essential GCP. The narrated part takes around one hour to complete.

What content is covered?

See a list of topics covered here.

Are there course notes?

There is an option to view course notes on screen as the programme advances. Course notes as a PDF attachment are provided. Additional attachments include a copy of the ICH GCP guidelines (E6 R2) and the book by Professor David Hutchinson entitled Essential GCP.

What is the exam?

Participants of the programme, who fully complete the training, are eligible to take an online exam leading to the “Certificate in Essential GCP”. The exam consists of multiple-choice questions in different formats. Participants who take the examination are given an instant result and those who pass are awarded the “Certificate in Essential GCP”.

Can the participants’ activity be tracked?

The participant’s progress is tracked by the Academy using a SCORM compatible learning management system. We can see when a participant logs on. We can track how much of the programme they undertake. We can see how they performed in the exam.We can see when they have fully completed the programme and passed the exam. Then we will issue certification. The participant does not need to contact us.

Will participants get a certificate?

Candidates who complete the entire programme will be sent a PDF certificate by email.

Are there any progress reports?

We provide progress reports on a regular basis, as agreed. These are sent to the project manager. Reports provide the activity status for each currently registered participant, by group, to that date, including the outcome of any exams.

How long is the participant given to undertake the training?

Usually 12 weeks. This is specified in the email sent to participants.

How do I enrol?

You may register and pay online by visiting our website. You can also send us an email and request registration. After receipt of payment we will send you a user name and password. This will allow you access to the programme purchased. Before you provide us with your personal information, make sure that you have read and accept our privacy statement.

What do I do next?

Book online or contact us by email to register or for further information info@brookwoodacademy.org

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