Protocol KSADS part 1 1045 Coffee break 1100 KSADS part 2 Good Clinical Practice Study medications amp logistics Laboratory procedures amp MRI 1230 Lunch Agenda morning ID: 780270
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Slide1
09:00 Welcome & introductions Protocol K-SADS part 1 10:45 Coffee break11:00 K-SADS part 2 Good Clinical Practice Study medications & logistics Laboratory procedures & MRI12:30 Lunch
Agenda - morning
Slide2Good Clinical Practice
Slide3Good Clinical Practice (GCP) is defined as a‘standard for the design, conduct, performance,monitoring, auditing, recording, analyses and reporting of clinical trials that providesassurance that the data and reported resultsare credible and accurate, and that the rights, safety and wellbeing of trial subjects are protected’ (ICH GCP)
Slide4General principles of GCPClinical research needs to be conducted in line with ethical principles of ICH, GCP, laws and regulationsClinical research can only be conducted when the expected benefits justify the expected risksRights, safety & well being of subjects prevail over interests of science and society
Slide5How to comply with ICH GCP?Involve qualified staffRespect the patients’ rightsRecord information appropriatelyProtect confidentialityHandle investigational products appropriatelyFollow the protocol
Slide6How to comply with ICH GCP? Thorough training for new team members is essential in complying to GCP!Onboarding program:If new colleagues join the study team, notify your monitorThe monitor will guide the new team member through the required trainingHe checks whether the new team member is sufficiently trained to start conducting protocol proceduresAnd checks whether this is sufficiently documented in study files If everything is OK, the new team member can start!
Slide7Parties involved in GCP
Slide8Frequent audit findings! Failures to adhere to protocol Eligibility criteria not met Randomization incorrect Required efficacy tests missing Changes made without authorization of sponsorFailures to maintain adequate/accurate records Data changes could not be verified Records destroyed or otherwise missing Medical course AEs not documented Failures to obtain proper consent Only verbal, no signatures Only signature of patient – who has informed? Qualified? Old version of IC IC obtained after protocol procedures
Slide9What is ‘Informed consent’?"Informed consent is a process by which a subject voluntarily confirms his or her willingness to participate in a particular clinical trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate”ICH 1.28
Slide10How to acquire informed consent? (1/2)Investigator must provide all relevant information, including risks & benefits.Clinical trial information must be presented in a way that ensures understanding.Allow adequate time for questions & answers.Subjects must understand that they are able to withdraw consent at any time.
Slide11How to acquire informed consent? (2/2)Participants must sign and date the most recent ERB approved informed consent document.The person administering the consent also signs and dates the form during that same visit.Participants are given a copy of the consent form and the originals are filed with the participants’ record.THIS HAPPENS BEFORE ANY PROTOCOL PROCEDURE!INFORMED CONSENT IS AN ONGOING PROCESSTHROUGHOUT THE STUDY!
Slide12Important notes on informed consentFor PURPOSE, minors are eligible for the study Rules & regulations for obtaining informed consent or assent differ per country Please make sure you are aware of your national laws on this topic!An extensive GCP training video will be available online beginning of 2016.