Clinical Trials Informaon System (CTIS) - Sponsor Handbook
Table of Contents
Execuve summary ............................................................................................................................ 1
Table of Contents ............................................................................................................................... 5
1. What CTIS is and what it does ......................................................................................................... 7
1.1. A brief introducon to CTIS ..................................................................................................................................... 7
1.2. Overview of Clinical Trial Applicaon (CTA) process in CTIS – from submission to decision and reporng ............ 8
1.3. CTIS go-live date ...................................................................................................................................................... 9
2. Geng access to CTIS – registraons ............................................................................................. 10
2.1. User self-registraon ............................................................................................................................................. 10
2.1.1. Mul-factor authencaon in CTIS .................................................................................................................... 11
2.2. Organisaon and Sponsor Administrator registraon ........................................................................................... 11
2.2.1. Organisaon registraon in OMS ....................................................................................................................... 11
2.2.2. Organisaon registraon locally in CTIS for use in CTIS ...................................................................................... 13
2.2.3. Sponsor Administrator registraon in EMA Account Management portal for use in CTIS ................................. 13
3. Management of users and organisaons in CTIS ............................................................................ 15
3.1. Key user management concepts in CTIS ................................................................................................................ 15
3.2. User roles concept in CTIS ..................................................................................................................................... 15
3.3. Organisaon-centric approach - Sponsor Administrator ....................................................................................... 16
3.4. Trial-centric approach – Clinical Trial Administrator .............................................................................................. 17
3.5. Markeng Authorisaon Holder (MAH) group of users ........................................................................................ 18
3.6. CTIS user personas and organisaon models ........................................................................................................ 18
4. How to get a clinical trial applicaon started in CTIS ...................................................................... 19
4.1. Introducon ........................................................................................................................................................... 19
4.2. Draing of the clinical trial applicaon dossier ..................................................................................................... 19
4.3. Clinical Trial Applicaon under evaluaon ............................................................................................................ 24
4.4. Clinical Trial Applicaon aer decision .................................................................................................................. 24
5. Transion from Direcve to Clinical Trial Regulaon ...................................................................... 25
5.1. Transion period .................................................................................................................................................... 25
5.2. Points to consider on transional arrangements .................................................................................................. 27
5.2.1. What trials should not be transioned ............................................................................................................... 27
5.2.2. Can the trial be transioned? ............................................................................................................................. 27
5.2.3. What are the assessment melines of transional trials ................................................................................... 29
5.3. How to create a transional trial in CTIS ............................................................................................................... 29
5.4. How to manage trials transioned to the CTR in CTIS ........................................................................................... 29
6. Product management in CTIS ........................................................................................................ 30
6.1. Medicinal product registraon in XEVMPD ........................................................................................................... 30
6.2. Medicinal product in CTIS extracted from XEVMPD .............................................................................................. 32
6.3. Adding an authorised medicinal product in CTIS ................................................................................................... 32
6.4. Adding an unauthorised medicinal product in CTIS .............................................................................................. 34
6.5. Medicinal product details in CTIS .......................................................................................................................... 35