Effective Management

Question 1

What does the clinical trial manager do?3

Answer 1

Plans before a trial, oversight and monitoring of a trial, helps ensure participant safety and accurate reporting of the results

Question 2

How does clinical trial manager oversee participant safety?

Answer 2

Audits, monitoring and inspections

Question 3

Who has ultimate responsibility for clinical trial oversight?

Answer 3

Sponsor

Question 4

How does sponsor oversee safety and pharmacovigillence?

Answer 4

1. 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

Question 5

What is the principal investigator responsible for?

Answer 5

Responsible and accountable for treatment, evaluation and data integrity

Question 6

What does the principal investigator need to do?

Answer 6

1. 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

Question 7

How does the principal investigator keep safety in check?

Answer 7

monitoring, oversight meetings and implementing quality and management systems

Question 8

What does the study monitor do?

Answer 8

Checks all aspects relating to trial are in compliance with the protocol

Question 9

Where are monitoring documents kept?

Answer 9

Trial master file

Question 10

Where is monitoring done?

Answer 10

Centrally or on -site

Question 11

What is the approach of monitoring?

Answer 11

Risk based approach

Question 12

What is safety monitoring and reporting and why is it done?

Answer 12

One of key activities performed in the course of recruitment, treatment and follow up. Protect participants and ensure benefits outweigh risks

Question 13

Why is it important to collect safety information on an ongoing basis?

Answer 13

New information comes to light

Question 14

How do we know about safety before start of trial?

Answer 14

Do systematic review or lit search of available data , IMPs might have an IB or a summary of product characteristics

Question 15

What should be done in terms of safety monitoring before the start of the trial?

Answer 15

1. 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

Question 16

what to do in terms of safety monitoring when the trial is open?

Answer 16

Consider changing risk/benefit profile of interventions

Question 17

Define adverse event

Answer 17

Any untowed medical event which happens in a patient in a CT

Question 18

Define Adverse reaction

Answer 18

Reasonable evidence to suggest a suspected casual association between trial drug and event - judged by PI. So definitely probably and possibly

Question 19

Serious AE or Serious AR: 4

Answer 19

Results in death/is life threatening / needs hospitalisation or prolonged hospitalisation / results in sig or persistent disability/ congenital anomaly or birth defect

Question 20

Unexpected Adverse Reaction

Answer 20

Nature and severity not consistent with applicable product in IB or Summary of Product Characteristics

Question 21

Suspected Unexpected Serious Adverse Reaction:

Answer 21

SUSAR - Any serious AR classified as unexpected - so serious, related and unexpected

Question 22

How to perform ongoing safety monitoring for participants?4

Answer 22

• collect baseline data
• Ask health related questions at every visit
• Record all untoward medical occurrences
• collect accurate and timely data related to safety

Question 23

What are the 3 regulatory requirements for safety reporting?

Answer 23

• notification of adverse events to sponsor
• Expedited reporting of SUSARs to regulatory authorities
• Annual reporting of SARs

Question 24

How to report SAEs 4

Answer 24

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

Question 25

How to report SUSAR (timeline)

Answer 25

7 days to MHRA/REC, 15 days to others

Question 26

What to do if adverse event / reaction in blinded trial?

Answer 26

Assume on active treatment

Question 27

When is it ok to unblind if adverse event?

Answer 27

Clinically and medically needed or event assessed as possible SUSAR

Question 28

Who is unblinding done by? how?

Answer 28

Individual not involved in trial - coded

Question 29

When are SAEs, SARs and SUSARs reviewed?

Answer 29

In TMGs

Question 30

Where is safety data also included in?

Answer 30

Reg report to IDMC

Question 31

When is frequency of review and meetings determined?

Answer 31

During risk Assessment of trial and documented in safety management plan

Question 32

What should be reported in safety reports to investigators by regulations?

Answer 32

Only SUSARs