Clinical Trial Directive: Reporting Forms and Templates
Under the Clinical Trials Regulation (CTR), all safety reporting is carried out through CTIS and the below reporting forms are not required.
For studies remaining under the Clinical Trial Directive (CTD), as part of the reporting requirements of Clinical Trials of Investigational Medicinal Products approved by the NREC-CT, please use the appropriate templates and forms below.
CTD Safety Reporting:
The Cover Form should be completed by the Sponsor and submitted to the National Office with any safety reports such as annual safety reports and reports of suspected unexpected serious adverse reactions.
CTD Annual Progress Report:
Annual Progress Reports must be submitted to the National Office on the anniversary date of final NREC approval and for every year thereafter for the duration of the study.
CTD Declaration of End of Trial:
The Declaration of End of Trial should be completed by the Sponsor. It should be submitted to the National Office within 90 days of the conclusion (last person - last visit) of the trial.
CTD End of Study Report:
The End of Study Report must be submitted to the National Office within 12 months of the end of the clinical trial.
All reporting documents should be submitted to the National Office via email to clinicaltrials@nrec.ie.