Compliance with protocol scheduling and patient retention in clinical trials: Flashcards
2 Reasons why it is important to follow protocol
Protocol describes rules of the trial and if we dont follow - jeopardise patient safety and data integrity
What is protocol deviation?
When without significant consequences, activities on a trial diverge from approved protocol
How could protocol deviations occur?3
Patient non adherence, non compliance by researcher, Dont result in harm to anyone or scientific value of results, documented in CRF or file note
What is protocol violation?
Divergence from protocol that potentially increases risk or decreases benefit, affects patients rights, safety or welfare or integrity of data, and there is a consistent variation in practice from protocol
3 things that would result from a protocol violation:
Decrease quality of data, make consent form inaccurate, impact a subjects safety, rights or welfare
What should be done if major violation?
Reported to sponsor within 3 days
Major vs Minor violation:
Major impact patients safety and effects data integrity
What is a serious breach of protocol?
Serious violation that is likely to effect to a significant degree either the safety of physical and mental integ of subjects or scientific value
What to do with a serious breach of protocol?
Sponsor should notify MHRA within 7 days of becoming aware
What are urgent safety measures?
Protocol amendments implemented ahead of regulatory approval for safety reasons to protect subjects against immediate hazard
What to do with urgent safety measures?
Inform MHRA by phone and in writing within 3 days
4 reasons for importance of patient retention:
Incomplete data sets, no study outcome, participants dont benefit, inconclusive data
Reasons why patients would leave:
Feeling no improvement, SEs, Assessment and treatment methods, length of the study…
What does the trial management group do in oversight?
Day to day management and monitor all aspects
What does the trial steering committee do for oversight?
Overall supervision on behalf of sponsor and funder
