College aantekeningen
Lecture 6
HC6 van Clinical Trials and Clinical Development
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Voorbeeld 2 van de 8 pagina's
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Lecture 6 Friday morningIRB/IEC – Investigator – Sponsor
IRB/IEC
IRB & IEC are different but have the same function, the difference is geography
IRB – US = legal power – you can end up in prison
IEC – EU & the rest of the world = no legal power just favourable opinion
But ICH says, you need a favourable opinion ICH is law so it ends up the same -> always
positive opinion/approval
AIEC = Accredited Ethics Committee
METC = Medisch Etische Toetsings Commissie
IEC has one job, to protect the right, safety & well-being of the subjects
-Special attention for trials that include vulnerable subject
-This when the outcome is of importance for the subjects/that population & the trial cannot
be done without them
IRB/IEC tasks
-They do benefit risk analysis for the subjects
-Reviewing and approving/providing favourable or non-favourable opinion on
-Trial protocol
-Suitability of the investigator
-Suitability of the facilities
-Methods and material to be used in obtaining and documenting informed consent of
the trial subjects
The documents they need for analysis are
-Protocol
-ICF + PIF (Patient Information Form)
-CV PI (Principal Investigator) -> not for approval
-IB -> not for approval it is a tool
-Letter with a statement from the BoD with their approval and a statement that they are up
to it
-All information written to subject, diaries/advertisements
-ABR = Algemeen Beoordelings- en Registratieformulier
-Insurance certificate for the trial, that the insurance covers for the number of patients you
enrol and the amount of the insurance must be high enough
Amendment to protocol has to be approved by IEC, except when in immediate hazard, to
protect the safety, rights and wellbeing of the subject.
IRB/IEC opinion -> see slide
-4 options
1
, -Approval/favourable opinion
-Modifications required prior to approval
-Disapproval/negative opinion
-Termination/suspension of prior given approval
th
-> 5 option; conditional approval; life up to conditions then chairman will sign and approve
without a 2nd round
IRB/IEC responsibilities
-Consider qualifications
-Continuously review each ongoing trial, but at least once per year
-Determine ethical aspects and applicable regulations in case of trials in emergency
situations
-Review payments to subjects
IRB/IEC composition
-At least five members
-At least 1 with non-scientific interest
-At least 1 who is independent of the institution/site
IRB/IEC Voting
-Only members who actually participate in the review and discussion vote
-Investigator may provide information on the trial but should not participate in voting
IRB/IEC Obligations
-Perform funcitons according to written operating procedures
-Maintain written records of activities and minutes of meetings
-Comply with GCP and applicable regulatory requirements
IEC Notifications
IEC should notify the investigator concerning:
-Its trial related decisions
-The reasons for its decisions
-Procedures for appeal of its decisions
Notification to IRB/IEC
Investigator should promptly report to IEC:
-Deviations from protocol to eliminate immediate hazard
-Changes increasing the risks to subjects
-All adverse drug reactions ADR that are both serious and unexpected
-New information that may affect adversely the safety of subjects or conduct of trial
EuCTD: ECs
-For multi-center trials only one single EC opinion for each participating Member State
-Ethics committee should have member with expertise in relevant disease and patient
population or seek advice from expert
-EC shall consider the relevance of a clinical trial and the anticipated benefits and risks
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