Clinical trial application (CTR): from start to finish

From start to finish: Clinical trial application under the CTR

1. Preparation

   1. Transparancy rules

      Transparancy rules

      • Transparancy rules: general information
      • Deferral public disclosure
      • Redacted and unredacted documents

   2. National or multinational

      National or multinational

      • National or multinational: general information
      • One research file: Part I and Part II
      • Full, staggered or mixed applications
      • Full or staggered application in the Netherlands
      • National Clinical Trial Office in the Netherlands

   3. Clinical Trials Information System (CTIS)

      Clinical Trials Information System (CTIS)

      • CTIS: general information
      • Registration CTIS
      • Roles and permissions
      • Organisation Management Service
      • Medicinal Product Registration

   4. Structure research dossier in CTIS

      Structure research dossier in CTIS

   5. Section Form and MSC

      Section Form and MSC

      • Cover letter
      • Proof of payment of fee
      • Compliance with Regulation (EU) 2016/679

   6. Research dossier Part I

      Research dossier Part I

      • Layout Part I application in CTIS
      • Protocol
      • Investigator's Brochure (IB)
      • Documentation relating to compliance with Good Manufacturing Practice (GMP) for Investigational Medicinal Product and Auxilliary Medicinal Product
      • Investigational Medicinal Product Dossier (IMPD)
      • Auxiliary Medicinal Product Dossier (AxMPD)
      • Scientific advice and Paediatric Investigational Plan (PIP)
      • Labeling IMP and AxMP

   7. Research dossier Part II

      Research dossier Part II

      • Layout Part II application in CTIS
      • Recruitment arrangements
      • Subject information, informed consent and informed consent procedure
      • Suitability of the investigator
      • Suitability of the facilities
      • Proof of insurance cover or indemnification
      • Financial and other arrangements
      • Compliance with national requirements on data protection
      • Compliance with use of biological samples

2. Submitting and assessment

   1. Submission

      Submission

      • Proposal for reporting Member State
      • Deadlines
      • Withdrawal

   2. Validation phase

      Validation phase

      • Validation phase: general information
      • Selection of reporting Member State
      • Validation

   3. Assessment phase

      Assessment phase

      • Assessment phase: general information
      • Assessment of Part I or Part I/II

   4. Conclusion, decision and appeal

      Conclusion, decision and appeal

      • Conclusion and opt out
      • Decision
      • Appeal

3. Conduct of study

   1. Notifications

      Notifications

      • Start of the clinical trial
      • End of recruitment
      • Temporary halt and restart
      • Early termination
      • Serious breaches
      • Unexpected events
      • Urgent safety measures
      • End of the clinical trial
      • Overview of notifications

   2. Modifications

      Modifications

      • Types of modifications
      • Submission of a substantial modification
      • Validation and assessment of a substantial modification
      • Timelines for substantial modifications
      • Addition of a Member State

   3. Intermediate data analysis

      Intermediate data analysis

   4. Safety reporting

      Safety reporting

      • Safety reporting: general information
      • (Serious) adverse events and SUSARs
      • Annual Safety Report

   5. Supervision

      Supervision

4. End of study

   1. End of study

   2. Summary of results

      Summary of results

   3. Clinical study report

      Clinical study report

   4. Archiving

      Archiving