Effective Management Flashcards
What does the clinical trial manager do?3
Plans before a trial, oversight and monitoring of a trial, helps ensure participant safety and accurate reporting of the results
How does clinical trial manager oversee participant safety?
Audits, monitoring and inspections
Who has ultimate responsibility for clinical trial oversight?
Sponsor
How does sponsor oversee safety and pharmacovigillence?
- check if measures are in protocol 2. Put a formal procedure in place for managing adverse reactions 3. Annual safety report 4. Reports adverse reactions to ethics committees and MHRA 5.Updates investigator’s broschure
What is the principal investigator responsible for?
Responsible and accountable for treatment, evaluation and data integrity
What does the principal investigator need to do?
- needs to make sure all staff are aware of safety and reporting requirements 2. ensure systems are in place to record and notify adverse reactions in accordance with regulations
How does the principal investigator keep safety in check?
monitoring, oversight meetings and implementing quality and management systems
What does the study monitor do?
Checks all aspects relating to trial are in compliance with the protocol
Where are monitoring documents kept?
Trial master file
Where is monitoring done?
Centrally or on -site
What is the approach of monitoring?
Risk based approach
What is safety monitoring and reporting and why is it done?
One of key activities performed in the course of recruitment, treatment and follow up. Protect participants and ensure benefits outweigh risks
Why is it important to collect safety information on an ongoing basis?
New information comes to light
How do we know about safety before start of trial?
Do systematic review or lit search of available data , IMPs might have an IB or a summary of product characteristics
What should be done in terms of safety monitoring before the start of the trial?
- Risk assessment and propose mitigations 2. Safety management plan 3. roles and responsibilities defined 4. Prepare safety section of protocol 5. training requirements 6. see if IDMC needed
what to do in terms of safety monitoring when the trial is open?
Consider changing risk/benefit profile of interventions
Define adverse event
Any untowed medical event which happens in a patient in a CT
Define Adverse reaction
Reasonable evidence to suggest a suspected casual association between trial drug and event - judged by PI. So definitely probably and possibly
Serious AE or Serious AR: 4
Results in death/is life threatening / needs hospitalisation or prolonged hospitalisation / results in sig or persistent disability/ congenital anomaly or birth defect
Unexpected Adverse Reaction
Nature and severity not consistent with applicable product in IB or Summary of Product Characteristics
Suspected Unexpected Serious Adverse Reaction:
SUSAR - Any serious AR classified as unexpected - so serious, related and unexpected
How to perform ongoing safety monitoring for participants?4
- collect baseline data
- Ask health related questions at every visit
- Record all untoward medical occurrences
- collect accurate and timely data related to safety
What are the 3 regulatory requirements for safety reporting?
- notification of adverse events to sponsor
- Expedited reporting of SUSARs to regulatory authorities
- Annual reporting of SARs
How to report SAEs 4
1-Procedure is in protocol, non serious AEs on patient CRF
2- if serious, SAE form signed by CI and notify sponsor within one day
3- log them, review events
4- reg and ethics notified
How to report SUSAR (timeline)
7 days to MHRA/REC, 15 days to others
What to do if adverse event / reaction in blinded trial?
Assume on active treatment
When is it ok to unblind if adverse event?
Clinically and medically needed or event assessed as possible SUSAR
Who is unblinding done by? how?
Individual not involved in trial - coded
When are SAEs, SARs and SUSARs reviewed?
In TMGs
Where is safety data also included in?
Reg report to IDMC
When is frequency of review and meetings determined?
During risk Assessment of trial and documented in safety management plan
What should be reported in safety reports to investigators by regulations?
Only SUSARs
