Clinical Trials

A commercial licence agreement is required to use the ECAS for commercially sponsored clinical trials.

To request a commercial licence, please contact Professor Sharon Abrahams: s.abrahams@ed.ac.uk

Procedure for Clinical Trials

ecas@ed.ac.uk
Prof Sharon Abrahams, s.abrahams@ed.ac.uk
Further guidance and training see https://ecas.psy.ed.ac.uk/

For Clinical Trials (commercial and non-commercial) the ECAS must be performed and evaluated in full accordance with the ECAS Guidelines of the University of Edinburgh.

Training and Certification

  1. All interviewers using the ECAS to collect data in a clinical trial must be certified to undertake the test. This is achieved by passing the training programme, see training tab on the ECAS website.
  2. Training and certification is provided for each interviewer separately and must be undertaken through the ECAS team at the University of Edinburgh.  The training programme is online and automated and takes a couple of hours to complete.
  3. To gain certification the interviewer must pass the assessment at the end. If the interviewer fails the assessment they can retake the assessment 2 more times and if they do not pass on their third attempt, a fourth assessment cannot be undertaken for 12 months.
  4. To ensure full reliability and consistency, every certified interviewer must pass a short re-certification assessment online every two years after their original certification.

Administering the ECAS in different languages

  1. A number of versions of the ECAS are available in different languages.
    These have been developed and validated together with local collaborators and have been adapted for local culture. Developing and validating a local version is not a simple task and cannot be done by a translation company. Anyone wishing to do this must gain permission from Prof Abrahams and the University of Edinburgh and follow the guidelines for translation found on the website under the International tab.
  2. The ECAS should be administered in the participant’s native language. If the person is bilingual they can be assessed in either language, but preferably the one they are most fluent and have had the most experience with.
  3. The interviewer should be fluent in that language. The ECAS should not be administered using a translator. A translator can be used to help translate the participant’s responses only.

Repeated administration of the ECAS over time

  1. In most languages 3 parallel versions are available (ECAS A, B and C) to be used for repeated assessment. If available these should be used always when repeating assessments over time. These should be administered in order with a minimum of a 4 month and preferably 6+ month gap in between each. This will ensure that the same version is not repeated within 12 months.
  2. In a few languages less than three versions are available only. Repeat these but ensure that you do not use small gaps in between (see point 1).

Commercial Licence Fees

  1. An estimated fee is provided for each study based on their intended design. This is based on several factors including the number of patients and administrations and the number of translated versions required. Please provide this information when contacting the ECAS team.
  2. Payment for training is done separately and is charged per trainee. This can be arranged within the license agreement or by a separate invoice.
    Once arranged the trial coordinator should provide the ECAS team at the University of Edinburgh with the list of names and email addresses. Once each trainee  has passed we will send you a copy of the certificate.
  3. The trial coordinator needs to monitor who will need recertifying and contact us to gain access in sufficient time. Note interviewers who have been certified within the last two years individually, or under a different project will not need to undertake the assessment again, but will need to do the brief re-certification within two years from the date of their previous certification.

Professor Sharon Abrahams & the ECAS Team
Psychology – Philosophy, Psychology and Language Sciences
University of Edinburgh
7 George Square
Edinburgh EH8 9JZ

Click here for a PDF version of the above Procedure for Clinical Trials.