WP03 - Education and Training

Objectives

  • To ensure that all individuals involved in the Project have received appropriate education and training, including knowledge of the Protocol and project timeframe, Good Clinical Practice, Ethics, and administration of tests and
  • rating instruments.
  • To ensure all the tests and rating instruments that are being used in the study and which are key clinical end points are administered in a harmonized fashion at all the clinical trial sites.
  • To provide on-line advice and educational support which can be accessed throughout the duration of the study, to clarify issues and support previous learning.

Workpackage Description

The WP leader will oversee the provision of education and training for all individuals involved in the Project. This will be achieved through face-to-face one-day training workshops, one for each language, supplemented
with on-line resources. Topics will include overview of nilvadipine, overview of the Project Protocol, principles of safety and Good Clinical Practice, Ethical considerations, overview of rating instruments, specific training in administration of standardised tests and evaluation of inter-rater reliability. The training materials and methods can be used for future NILVAD activities and other IDCTs.

Task 1: Preparation and production of training manual and training materials, including video demonstrations. Both English and non-English versions will be developed in cooperation with designated experts in each country. The experts will be chosen from individuals who are experts in clinical trials and statistical analyses.

Task 2: Workshop presentations to overview nilvadipine and the Project Protocol (with input from WP1), safety and Good Clinical Practice (with input from WP5), and Ethics (with input from WP3).

Task 3: Workshop presentations and demonstrations regarding all rating instruments, including administration and scoring conventions and common problems encountered. On-line support will augment this training.

Task 4: Workshop presentations, including video demonstration and hands on role play training, regarding all standardised tests including administration and scoring conventions and common problems encountered. This will include evaluation of inter-rater concordance during the workshops On-line support will augment this training.

Task 5: On-line educational and support resources will be developed which can be accessed at any time during the study, to augment the face-to-face workshop training.

WP Leader

St. James's Hospital (Dr. Robert Coen)