Timelines from EU Directives 2001/20 and 2005/28 and Medicines
for Human Use (Clinical Trials) Amendment Regulations
2006
Applications
- 30 days for MHRA to respond to CTA application.
- 60 days for REC to respond to EC application for favourable
opinion.(clock stops during request for extra info once)
- At present, no timeline for Trust R & D approval but need
CTA from MHRA and favourable opinion from EC before Trust approval
is given and study can start.
SAE/SUSAR reporting
- Investigator to report SAE/SUSAR to Trust R & D (sponsor)
immediately or within 24 hours of first knowing of event. Follow-up
information to be sent within a further 5 days.
- 7 days for sponsor (Trust) to notify MHRA (and main REC) of
fatal or life-threatening SUSAR, 8 days to send any follow-up
info.
- 15 days for sponsor (Trust) to notify MHRA (and main REC) of
all other SUSARs.
- SAEs do not require expedited reporting.
Annual reports
- 1 year from obtaining the EC favourable opinion, PI to send an
annual progress report (APR) to the main REC and copy to the
Trust.
The report template is on the NRES website. See useful
websites/links.
- 1 year from the MHRA clinical trial authorisation being issued,
PI to send an annual safety report to the MHRA and copies to main
REC and Trust.
The report template is on the R&D intranet site (GCP
Documents) and site
index (site index/site map/ gcp forms).
Substantial amendments
- 35 days REC to respond to substantial amendment application for
favourable opinion (and MHRA to object, no timeline for Trust
endorsement).
- 3 days to notify MHRA, REC & Trust of urgent safety
measures by submitting a substantial amendment form.
See GCP SOP03 for details on the R&D intranet site (GCP
Documents) or site
index (site index/site map/ gcp forms).
Temporary halt of a trial
- Immediately notify MHRA, REC & Trust by submitting a
substantial amendment form & giving reasons.
- To restart the trial, make the request as a substantial
amendment to MHRA, REC & Trust – providing safety
evidence.
See GCP SOP03 for details on the R&D intranet site (GCP
Documents) or site
index (site index/site map/ gcp forms).
End of trial
- 90 days for sponsor (delegated to PI) to notify MHRA and REC
that a trial has ended. Copy to Trust. Use End of Trial Declaration
form. See useful
websites/links.
- 15 days if trial ended prematurely & give reasons.
- Within 1year for PI to submit a publication or clinical trial
report to MHRA, REC and Trust.
Archiving
- 5 years minimum after study end (last patient, last visit) to
archive Trial Master File, patient study data (CRFs), pharmacy
study file and study patients medical records (in paper form).
Notification of serious breaches
- Sponsor (Trust) to notify MHRA of any serious breach of GCP or
trial protocol within 7 days of becoming aware of that
breach.
A serious breach is likely to affect to a significant degree
either the safety or physical or mental integrity of the trial
subjects or the scientific value of the trial.
Acronyms
CTA: Clinical Trial Authorization
GCP: Good Clinical Practice
IMP: Investigational medicinal product
MHRA: Medicines & Healthcare Regulatory Agency
NRES: National Research Ethics Service
PI: Principal Investigator
SAE: Serious adverse event
SUSAR: Suspected unexpected serious adverse reaction