The accredited ACRO Basic Monitor Training Course is aimed at internal QC monitors working at research sites. The course blends classroom presentations and interactions.
The course specific content ensures that trainees are equipped with a sound knowledge of local as well as international clinical trial environments and the applicable regulatory frameworks. It is ACRO's intention to work with local institutions and regulators to add regional specific content so that the training is available and relevant to trainees from other African countries.
All local ACRO trainers are accredited by the South African Qualifications Authority.
An initial eight days spent in the classroom at the ACRO offices in Johannesburg completing modules in theory and practice will provide the foundation on which trainees build during the ensuing six months of vocational training. It is strongly recommended that trainee monitors have one accompanied site visit (ASV) conducted by an ACRO facilitator or delegated colleague within the six month vocational session.Trainees then complete the course by returning to the classroom for a consolidation period lasting five days.
Foundation Period - In the classroom, trainees will monitor a simulated clinical trial to enhance their understanding of theoretical concepts. At the end of this classroom period, trainees will undergo a written assessment. A minimum pass mark of 80% is required.
Vocational Training Period - Trainees will have email and telephonic access to the ACRO trainers. The Trainee internal monitors should also experience one two day ASV to identify any possible gaps, to discuss any issues they've experienced, and to receive additional training on selected topics covered during the foundation period course as applicable.
ACRO will schedule regular feedback with the trainee's manager to monitor progress and address any retraining issues that might arise.
Trainees will be required to compile a portfolio of evidence during this period, consisting of completed core in-house and site-related activities in addition to a record of completed development exercises. The activities can be customised to address the needs of individual employers and organisations.
Consolidation Period - The course ends with five days spent in the classroom completing further theory and practical topics. At the end of this period, trainees will undergo a second written assessment. A minimum pass mark of 80% is required.
THE BASIC MONITOR TRAINING COURSE SCHEDULED DATES
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Ideally, this course is aimed at people who have an Industry recognised tertiary qualification, and at least one year's trial experience as a member of staff e.g. study coordinator at an investigative site, or six months experience as a CRA or internal monitor.
In order to be able to fulfill the six month vocational training requirement, the trainee should be currently employed in a monitoring position, or taking up employment in this capacity at the end of the initial eight day classroom training.
Classes are limited to 12 delegates so as to provide individual attention.
To qualify for an ACRO Certificate of Completion, trainees are required to obtain a Certificate of Completion Part 1 and Part 2, and submit a copy of their completed portfolio of evidence compiled during the 6 month vocational training period.
Trainees who do not pass a written assessment at the first attempt may choose to rewrite the applicable assessment, or to receive a Certificate of Attendance.
A FEW COMMENTS FROM SOME OF THE PARTICIPANTS
For further information, please contact our team using the information provided below:
Tel: +27 (0)11 470 2800