January 2022: CTIS Training Update

European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on January 20, 2022, by adding new and updated versions of documents in Modules 08 and 17:

  1. Module 08 – Step-by-step guide: How to evaluate an Additional MSC clinical trial application (Add MSC CTA) (v1.0): It defines Add MSC CTA and the step-by-step procedure for its evaluation. It mainly includes assessment and decision along with its timeline and screenshots for better understanding.
  2. Module 08 – Step-by-step guide: How to evaluate a Substantial Modification clinical trial application (v1.0): It defines substantial modification and the step-by-step procedure for its evaluation. It mainly includes validation, assessment, and decision along with its timeline and screenshots for better understanding.
  3. Module 08 – Quick guide – Part II: How to evaluate an Initial Clinical Trial Application: Assessment and Decision  (v1.2): Updated by modifying the flowchart of ‘Roles and permissions’
  4. Module 08 – Quick guide – Part I: How to evaluate an Initial Clinical Trial Application: Assessment and Decision (v1.2): Updated by modifying and adding ‘Decision-maker submitter’ to the flowchart of ‘Roles and permissions’
  5. Module 08 – Quick guide – Decision: How to evaluate an Initial Clinical Trial Application: Assessment and Decision (v1.2): Updated by adding steps to be taken if an ethics committee has issued a negative opinion by the law of that MSC in the section of ‘Process to submit the decision’
  6. Module 08 – FAQs: How to evaluate an Initial Clinical Trial Application: Assessment and Decision (v1.2): Updated by adding section “4.11 How a CTA decision can be changed from ‘Authorized with conditions’ to ‘Authorized’?”
  7. Module 08 – Quick Guide – Introduction: How to evaluate an Initial Clinical Trial Application: Assessment and Decision (v1.2): Updated by adding the section ‘Assessment and decision of an initial clinical trial application’ which mentions that the evaluation of an initial clinical trial has three main phases including validation, assessment, and decision. It also briefly explains parts of the assessment along with their timelines.
  8. Module 08 – Instructor’s guide: How to evaluate an Initial Clinical Trial Application: Assessment and Decision (v1.2): Updated by adding ‘Step-by-step guides’ in materials available in sections 2 and 5.
  9. Module 17 – FAQs: Supervise a Clinical Trial: Ad Hoc Assessment (v1.2): Updated by adding questions 1.5  and 4.3 related to corrective measures and suspended trails. Also, question 3.2 in the previous version was replaced by the question ‘3.6 Can the sponsor view the Member States discussion on ad hoc assessment’ in the latest version