The various bodies involved in the funding, regulation, sponsorship and approval of health research have specific reporting requirements that must be complied with throughout the life cycle of a research study. The nature and timing of the reports required will depend on the study type. The table below summarises the main reporting requirements (for studies where a Noclor partner is sponsor).
All reports and related acknowledgements and correspondence should be retained in the relevant section of the Study/Trial Master File (S/TMF).
| REPORT TYPE | REPORT DUE DATE | REPORT REQUIREMENTS | STUDY TYPE | |
|---|---|---|---|---|
| Annual Progress Reports to Research Ethics Committee (REC) | The anniversary of the REC approval (not the date the study commenced). To be submitted within 30 days of the anniversary (unless the study has officially declared ended before this anniversary) | Progress report should be prepared and submitted by the Chief Investigator using the appropriate template. Reports should be disseminated to Noclor Sponsor Representative and Principal Investigators. | All research with a favourable ethics opinion | |
| End of Study | Notification | Within 90 days of the study ending (end as defined in the protocol) | Declaration of the End of Study Form should be completed by Chief Investigator and submitted to Noclor Sponsor Representative, REC and Principal Investigators | Non-CTIMPs |
| Declaration of the End of a Clinical Trial form (CTIMP) should be completed by the Chief Investigator and submittted to Noclor Sponsor Representative (who will submit to MHRA), REC and Principal Investigators | CTIMPs | |||
| Early termination | Within 15 days of decision to terminate early being made | Declaration of the End of a Clinical Trial form (CTIMP) should be completed by the Chief Investigator and submittted to Noclor Sponsor Representative (who will submit to MHRA), REC and Principal Investigators | CTIMPs | |
| Summary Study/Clinical Trial Report | Within 12 months of the end date (the date provided in the end of study declaration not the date the form was submitted) | The Chief Investigator should send a final summary report to the Noclor Sponsor Representative, REC and disseminate to Principal Investigators | Non-CTIMPs | |
| The Chief Investigator should send the final summary clinical trial report to the Noclor Sponsor Representative within 11 months of the end of the trial declaration. The Sponsor Representative will authorise submission of report by the Chief Investigator to the REC, MHRA and Principal Investigators | CTIMPs | |||
| Finance Report /Funder Progress Reports | According to the conditions of funding/ contract | The Chief Investigator should review the research budget against expenditure on a quarterly basis (minimum requirement) and provide these budget reports to Noclor (Senior Management Accountant) where a Noclor partner is sponsor of the study. Copies of all progress reports to funder should be copied to Noclor Sponsor Representative |
All funded research | |
| Incident Reporting | According to local Trust policy | For research sponsored by a Noclor partner, the incident should be also be reported to the Noclor Sponsor Representative (directly through the incident reporting system where possible by including sponsor.noclor@nhs.net as one of the reviewers of the incident report) | All research | |
| Recruitment Reports - NIHR Portfolio Studies | Monthly | Report anonymised study recruitment data onto the Clinical Research Network’s Portfolio Database. Download the leaflet explaining how to report NIHR recruitment data |
NIHR portfolio studies | |
| Reporting Protocol Violations and non-compliance | Within 24 hours | Minor and major protocol violations and non-compliance should be reported to the Noclor Sponsor Representative (and copied to the Chief Investigator) by submitting the Noclor Non-Compliance Report Form within 24 hours of becoming aware of the violation /non-compliance | All research | |
| Safety Reports | DSURs | One year anniversary of Clinical Trial Authorisation (CTA) | DSUR will be prepared by Chief Investigator or person delegated responsible for Pharmacovigilance by the sponsor. DSUR to be submitted to MHRA by Noclor Sponsor Representative or person delegated responsible for Pharmacovigilance. Copy of DSUR should be sent to main REC by Chief Investigator (with REC safety report cover sheet) and to Principal Investigators. | CTIMPs |
| SAEs | Within 24 hours to sponsor | All SAEs should be reported to sponsor according to the protocol and Noclor Safety Reporting SOPs. | Clinical Trials | |
| Within 15 days to main REC | SAEs judged as related and unexpected should be reported by the Chief Investigator to main REC within 15 days of being made first aware using NRES template (copy of report and correspondence should be sent to Noclor Sponsor Representative) | Non-CTIMP Clinical Trials | ||
| SUSARs | Within 7 calendar days of first notification to sponsor for fatal /life threatening SUSARs, and within 15 calendar days of first notification to sponsor for all other SUSARs | Sponsor (or person delegated responsible for Pharmacovigilance) to report SUSAR to MHRA and main REC according to sponsor SOPs (REC report should be sent with REC safety report cover sheet). SUSARs to be disseminated to Principal Investigators by the Chief Investigator | CTIMPs | |
| USMs | Reported verbally immediately to Noclor Sponsor Representative/Chief Investigator and REC (MHRA for CTIMPs). Reported officially by notice of substantial amendment within 3 days. | The Chief Investigator (or sponsor representative as agreed) should make initial notifications by telephone to the REC (and for CTIMPs the MHRA Clinical Trial Unit) Notify the main REC (and MHRA for CTIMPs) by substantial amendment within 3 days of the USM being taken |
Clinical Trials | |
| Serious Breaches | Within 7 calendar days of Noclor (sponsor) becoming aware of potential serious breach | Noclor Sponsor Representative will make judgement as to whether a serious breach has occurred that requires reporting to REC (MHRA for CTIMPs). Reported serious breaches should be circulated to Principal Investigators by the Chief Investigator |
All Research | |
| Sponsor Update Reports | According to agreed study-specific monitor plan | Noclor Sponsor Representative should be copied in all reports (as instructed as allows sponsor oversight). Notes should be made of meetings /TCs, and copies of email correspondence retained for the Study/Trial Master File (S/TMF) | All sponsored research | |
| Temporary Halts | Within 15 days of the decision to temporary halt | Notified to REC (and MHRA for CTIMPs) as a substantial amendment within 15 days of the decision being taken to halt the trial | Clinical Trials | |