This course is designed to give hands-on practical experience to those new in the field who hold little clinical research knowledge, experience or skills. At the end of this course, the employee will receive a certificate for the course.

Course content:

-The History, Structure and Functions of Clinical Research

-Data Management, ICH-GCP Regulations and Review Boards

-Study Participant Management (Informed Consent & Safety), Privacy of   Information and Quality Control (Monitoring)

-Essential Document Maintenance in compliance with Canadian and   International Regulations and Quality Assurance (Audit & Inspection)

Training is conducted onsite, over a 3-day period equaling 21-hours, accommodating a maximum of 3 persons.

This option is for any experienced or practicing professional, that holds any research position, and could benefit from the reinforcement of select topics, to sharpen their research knowledge and skills, and maximize their on-the-job application and contributions, toward improving the success rate of trials.

We provide support to your team by showing you “HOW TO” in whatever area of clinical research activities that you may have the need. For example, mentoring support to your junior research staff, guiding your new QA officer to set up a quality assurance program, preparing your study files for inspection, etc. Just let us know what you need and we will provide the solution!!

This interactive course offers professional training and certification in good clinical practice for those new in the field and for professionals whose certification is up for renewal.

This course was designed by two highly experienced clinical research professionals (both with combined roles of senior auditor, clinical study manager, site study coordinator/nurse, senior monitor) to give new or aspiring investigators (or even those wanting a 'refresher’) concise and relevant knowledge for this very important role. It can also be offered to investigators who following a health authority inspection, had an observation of inadequate Investigator oversight.

By the end of this course, the Investigator will understand his/her role and responsibilities (and those of his/her team) in the conduct of a clinical study; delegation of tasks; protocol compliance; regulatory and ethical expectations; source and essential documents; safety reporting; visits from monitors, auditors and inspectors; and the dual role of sponsor-investigator.

This 2.5-hour training can be conducted onsite or remotely the period.

This 8-hour course is designed for Clinical Research Clerks who assist CRAs (example, CRAs working from home or consultants CRAs who require clerical help) in various administrative tasks (such as filing) in order to give them a general knowledge and understanding of clinical research, the sponsor master file, essential documents, and CRA visits to sites.

This training is only offered remotely.