Class notes
Lecture 6
- Course
- Institution
HC6 van Clinical Trials and Clinical Development
[Show more]
Seller
Follow
annelotte444
Content preview
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
2
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller annelotte444. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $3.21. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
71947 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now