Authorities - Submission, Approval and Notifications - 1.9
Ongoing Trial Reports and Notifications - SOP 1.9.b
Changes from the Previous Version
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, often delegated to the national co-ordinating investigator/project leader, has the responsibility for the submission of reports/notifications through the CTIS.
The sponsor may transfer any or all of the sponsor's trial-related duties and functions to a third-party vendor such as a Contract Research Organisation (CRO), but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The sponsor should ensure oversight of any 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 the CTIS are shown 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 webpage of the hospital should be updated when recruitment is closed. Local hospital procedure should be followed.
All reports and notifications which are submitted will be filed in the Trial Master File (TMF)/Investigator's Site File (ISF). Submitted documents must be available for audits and inspections. See Study Files – SOP 1.6.a.
Reporting Procedures and Deadlines
The sponsor, often delegated to the national coordinating investigator/project leader, 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 Modifications after Trial Start – SOP 1.9.c | |
| Safety issues | ||
| Suspected unexpected serious adverse reactions (SUSAR). | Strict deadlines (7 and 15 days), see Safety reporting - SOP 1.4.b | See Safety reporting - SOP 1.4.b |
| DSUR/annual report (trials on-going for more than one year). | No later than 60 days after DIBD, which is the clinical trial approval date in any participating country. First report after one year. | See Safety reporting - SOP 1.4.b |
| Ethics Committees can, if the committee finds it necessary, set the requirements for annual or other reports. | If necessary and as required by the Ethics Committee. | Through CTIS. |
| 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 becoming aware of the breach. | See Protocol Deviation Handling - SOP 1.10.b. 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. | Through CTIS. |
| Summary of result of the clinical trial. | Within one year of the end of the trial. | Through CTIS. |
| Lay person summary of results. | Within one year of the end of the trial, see Good Lay Summary Practice Guidance. | Through CTIS. |
References
External References
- Clinical Trials- Facility Status
- Clinical Trials- Overall Status
- Clinical Trials - Primary Completion Date
- Good Lay Summary Practice
- EudraLex Volume 10
- REGULATION (EU) No 536/2014 of The European Parliament and of the Council on clinical trials on medicinal products for human use
- ICH Guideline for Good Clinical Practice (GCP) E6 (R2)
- NoMAs website: Klinisk utprøving av legemidler
- REK KULMU website
Internal References
