Authorities - Submission, Approval and Notifications - 1.9
Ongoing Trial Reports and Notifications - SOP 1.9.b
Changes from the Previous Version
CT SOP version 2.0
Updated from version 1.0 to adapt to the wording used in ICH GCP R3.
Updated instructions for how to both submit and download reports and notifications from CTIS, and requirement for archiving of these documents in the TMF.
Added timelines for reporting in paediatric trials.
Updated links to attachments and references.
CT SOP version no 1.0.
Main changes from LM SOP 3.3. Adapted to clinical trial regulation 536/2014.
Responsibilities
The sponsor has overall responsibility for ensuring that this SOP is followed.
The sponsor’s responsibilities shall be described in the quality system of the sponsor institution. Tasks are delegated according to SOP Roles and Responsibilities in clinical trials implemented in the institution.
The sponsor is responsible for submitting reports and notifications in CTIS. The coordinating investigator should perform this task on behalf of sponsor.
The sponsor may transfer some or all of the sponsor's trial-related duties and functions to a service provider such as a Contract Research Organisation (CRO), but the ultimate responsibility for the quality and integrity of the trial data always remains with the sponsor. The sponsor should ensure oversight of trial-related duties and functions carried out on its behalf. Transfer of duties shall be specified in a written agreement.
Procedures
Reporting Requirements
The sponsor must ensure compliance with the requirements for submission of various types of reports and notifications while the trial is ongoing. The reports and notifications to be sent through CTIS are listed in the Table in "Reporting Procedures and Deadlines" below.
For the few trials that should be registered in clinicaltrials.gov, the information should be updated every 6 months after initial registration. Also the status for each site and for the trial as a whole including completion should be recorded within 30 days.
The hospital's website should be updated when the trial is closed for recruitment. Local procedure should be followed.
All annual safety reports and notifications to authorities are submitted in CTIS during study conduct and should be filed in the Trial Master File (TMF), see SOP Study files Submitted documents must be available for audits and inspections. For notifications (i.e. date for milestones, unexpected events, serious breaches, urgent safety measures, inspections by a third country inspectorate) reports can be downloaded from CTIS as a pdf file.
Reporting Procedures and Deadlines
The sponsor coordinating investigator, will submit the following reports/notifications as necessary:
WHAT SHOULD | DEADLINE | FORMAT/COMMENTS |
| Administrative issues | ||
Clinical trial start in each country. | Within 15 days. | Form in CTIS
To respective Member State concerned |
First patient first visit in each country. | Within 15 days. | Form in CTIS
To respective Member State concerned |
End of recruitment in each country. | Within 15 days. | Form in CTIS
To respective Member State concerned |
End of trial in each country. | Within 15 days. | Form in CTIS
To respective Member State concerned |
| End of trial – EU/EEA. | Within 15 days. | Form in CTIS
To all Member States concerned |
End of trial – overall (including third countries). | Within 15 days. | Form in CTIS
To all Member States concerned |
Clinical trials that were approved but did not start. | As soon as the decision is taken that the trial will not start. | Form in CTIS
To all Member States concerned |
| Scientific issues | ||
| Substantial modification. | See SOP Modifications after Trial Start | |
| Safety issues | ||
| Suspected unexpected serious adverse reactions (SUSAR). | Strict deadlines (7 and 15 days), see Safety reporting - SOP 1.4.b | See SOP Safety reporting |
| DSUR/annual safety report (trials on-going for more than one year). | For unauthorised products, no later than 60 days after DIBD, which is the clinical trial approval date in any participating country.
For authorised products, no later than 60 days after the initial approval of the trial in CTIS
First report after one year. | Through CTIS
See SOP Safety reporting |
| Temporary halt or early termination for reasons of subject safety (benefit-risk balance), and other reasons. | No later than 15 days after halt. | Form in CTIS |
| Unexpected events, which affect the benefit-risk balance of the clinical trial. | No later than 15 days from the date becoming aware of this event. | Form in CTIS |
| Urgent safety measures. | No later than seven days from the date the measures have been taken. | Form in CTIS |
| Restart after temporary halt for safety reasons. | No later than 15 days after restart. | Form in CTIS |
| Compliance | ||
| Serious breaches. | No later than seven days of the sponsor becoming aware of the breach. | See SOP Protocol Deviation Handling
Through CTIS |
| Inspection reports of third country authorities concerning the clinical trial. | When applicable. | Form in CTIS |
Results | ||
| Summary of result of intermediate data analysis. | Within one year of the intermediate data analysis date
Within 6 months for paediatric trials | Through CTIS |
| Summary of result of the clinical trial. | Within one year of the end of the trial
Within 6 months for paediatric trials | Through CTIS |
| Lay person summary of results. | Within one year of the end of the trial, see Good Lay Summary Practice Guidance
Within 6 months for paediatric trials | Through CTIS |
In CTIS the ASR-submitter role must be assigned to a dedicated user and then becomes visible in the blue-line menu. The forms for notifications are accessed by opening the trial and selecting «Notifications» on the grey-line menu beneath the trial title.
The forms for reporting unexpected events, serious breaches, urgent safety measures, inspections by a third country inspectorate, are found further down on the same page.
Attachments
References
External References
- ClinicalTrials.gov - Facility Status
- ClinicalTrials.gov- Overall Status
- ClinicalTrials.gov - Primary Completion Date
- Good Lay Summary Practice
- EudraLex Volume 10
- Regulation for clinical trials 536/2014
- ICH GCP R3
- NoMAs website: Klinisk utprøving av legemidler
- REK KULMU website
Internal References
